Heart Failure, Mitral Regurgitation, Mitral Valve Regurgitation, Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects
Conditions
Keywords
Functional Mitral Regurgitation, Mitral Valve Regurgitation, Symptomatic Heart Failure, Functional MR, MitraClip, Mitral Valve Insufficiency, Cardiopulmonary exercise testing, COAPT CAS, COAPT Continued Access Study, MitraClip NT
Brief summary
The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. This randomized controlled trial will provide the opportunity to strengthen or add labeling claims regarding safety and clinical benefits of the MitraClip System for symptomatic heart failure patients with moderate-to-severe or severe functional mitral regurgitation. Approximately 610 subjects will be randomized at up to 100 investigational sites with approximately 305 subjects targeted to receive the study device. COAPT study completed recruiting subjects in June 2017. As part of the COAPT trial, a subset of patients will be registered in the cardiopulmonary exercise (CPX) sub-study. The objective of this sub-study is to evaluate the exercise responses in a sub-cohort of COAPT subjects who receive MitraClip device (Device group) compared to the Control group who do not receive MitraClip device. (Note: the CPX Sub-study subjects will contribute to the analyses of the COAPT primary and secondary endpoints) As an extension of the COAPT RCT trial, COAPT CAS study will be conducted after COAPT enrollment is complete under the same investigational device exemption (IDE(G120024)). The objective of this study is to evaluate the MitraClip® NT System for the treatment of clinically significant functional mitral regurgitation (FMR) in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. The anticipated Study Completion Date is July 2024. COAPT CAS completed recruiting subjects in March 2019.
Detailed description
Prospective, randomized, parallel-controlled, multicenter clinical evaluation of the MitraClip device for the treatment of clinically significant functional mitral regurgitation in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. Eligible subjects will be randomized in a 1:1 ratio to the MitraClip device (Device group) or to no MitraClip device (Control group). As part of the COAPT trial, a subset of patients (at least 50 up to 100 in total) will be registered in the CPX Sub-study, which is designed as a prospective, randomized (1:1 ratio to the MitraClip or no MitraClip device), parallel-controlled, multicenter study registering approximately 50-100 subjects in up to 50 qualified US sites from the COAPT trial. Subjects registered and randomized in the CPX Sub-study will contribute to the total enrollment approximately of 610 subjects in the COAPT trial. Roll-in subjects will not participate in the CPX Sub-study. The COAPT CAS study is designed as a prospective, multicenter, single arm, continued access registry study. A maximum of 800 subjects (anticipated) will be registered from up to 75 sites in the United States. The enrollment will end once pre-market approval (PMA) of the proposed expanded indication of MitraClip System is obtained. Active follow-up of patients will be performed through 12 months with scheduled visits at 30 days and 12 months. The national Trans catheter Valve Therapy Registry (TVT Registry) will be used for data collection through 12 months. Annual follow-up data from 2 years through year 5 post-implant will be obtained by linkage to the Centers for Medicare and Medicaid Services (CMS) Claims database. COAPT CAS data may be used to support the PMA application of the labeling claims for the treatment of moderate to severe or severe FMR in symptomatic heart failure subjects. This single arm registry will provide valuable new information regarding use of the MitraClip® NT System under more real world conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. A total of 162 subjects were enrolled in the COAPT CAS Group.
Interventions
DEVICEMitraClip System
Percutaneous mitral valve repair using MitraClip System
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
614 in the Randomized Group for COAPT Trial and 162 Subjects in the COAPT CAS Group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within 180 days prior to subject registration, with MR severity based principally on the TTE study, confirmed by the Echocardiography Core Lab (ECL). The ECL may request a transesophageal echocardiogram (TEE) to confirm MR etiology. Note: Functional MR requires the presence of global or regional left ventricular wall motion abnormalities, which are believed to be the primary cause of the MR. If a flail leaflet or other evidence of degenerative MR is present, the subject is not eligible even if global or regional left ventricular systolic dysfunction is present. Note: Qualifying TTE must be obtained after the subject has been stabilized on optimal therapy including Guideline Directed Medical Therapy (GDMT) and at least 30 days after: 1. a greater than 100% increase or greater than 50% decrease in dose of GDMT 2. revascularization and/or implant of Cardiac Resynchronization Therapy device (CRT or CRT-D) or reprogramming of an implanted CRT or CRT-D that results in increased biventricular pacing (from \<92% to ≥92%) 2. In the judgment of the HF specialist investigator at the site, the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure (e.g., with cardiac resynchronization therapy, revascularization, and/or GDMT). The Eligibility Committee must also concur that the subject has been adequately treated. 3. New York Heart Association (NYHA) Functional Class II, III or ambulatory IV. 4. The Local Site Heart Team (CT surgeon and HF specialist investigators) and the Central Eligibility Committee concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy for the subject, even if the subject is randomized to the Control group. 5. The subject has had at least one hospitalization for heart failure in the 12 months prior to subject registration and/or a corrected brain natriuretic peptide (BNP) ≥300 pg/ml or corrected n-Terminal pro- brain natriuretic peptide NT-proBNP ≥1500 pg/ml measured within 90 days prior to subject registration (corrected refers to a 4% reduction in the BNP or NT-proBNP cutoff for every increase of 1 kg/m2 in BMI above a reference BMI of 20 kg/m2). Note: BNP or NT-proBNP must be obtained after the subject has been stabilized on GDMT and at least 30 days after: 1. a greater than 100% increase or greater than 50% decrease in dose of GDMT 2. revascularization and/or implant of Cardiac Resynchronization Therapy device (CRT or CRT-D) or reprogramming of an implanted CRT or CRT-D that results in increased biventricular pacing (from \<92% to ≥92%). 6. Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50% within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI). Note: The method must provide a quantitative readout (not a visual assessment). 7. The primary regurgitant jet is non-commissural, and in the opinion of the MitraClip implanting investigator can be successfully be treated by the MitraClip. If a secondary jet exists, it must be considered clinically insignificant. 8. Creatine Kinase-MB (CK-MB) obtained within prior 14 days \< local laboratory Upper Limit of Normal (ULN). 9. Transseptal catheterization and femoral vein access is determined to be feasible by the MitraClip implanting investigator. 10. Age 18 years or older. 11. The subject or the subject's legal representative understands and agrees that should he/she be assigned to the Control group, he/she will be treated with medical therapy and conservative management without surgery and without the MitraClip, either domestically or abroad. If the subject would actively contemplate surgery and/or MitraClip if randomized to Control, he/she should not be registered in this trial. 12. The subject or the subject's legal representative has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent. 13. Left Ventricular End Systolic Dimension (LVESD) is ≤ 70 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject registration. For the CPX Sub-study: Subjects have to meet the COAPT study eligibility criteria to be registered in the CPX Sub-study. COAPT CAS study Inclusion Criteria: 1\. Subjects must meet all of the above COAPT RCT inclusion criteria, and must have national Medicare coverage by the Centers for Medicare and Medicaid Services (CMS).
Exclusion criteria
1. Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use. 2. Untreated clinically significant coronary artery disease requiring revascularization. 3. Coronary artery bypass grafting (CABG) within 30 days prior to subject registration. 4. Percutaneous coronary intervention within 30 days prior to subject registration. 5. Transcatheter aortic valve replacement (TAVR) within 30 days prior to subject registration. 6. Tricuspid valve disease requiring surgery or transcatheter intervention. 7. Aortic valve disease requiring surgery. 8. Cerebrovascular accident within 30 days prior to subject registration. 9. Severe symptomatic carotid stenosis (\> 70% by ultrasound). 10. Carotid surgery or stenting within 30 days prior to subject registration. 11. American College of Cardiology /American Heart Association (ACC/AHA) Stage D heart failure. 12. Presence of any of the following: * Estimated pulmonary artery systolic pressure (PASP) \> 70 mm Hg assessed by site based on echocardiography or right heart catheterization, unless active vasodilator therapy in the cath lab is able to reduce the pulmonary vascular resistance (PVR) to \< 3 Wood Units or between 3 and 4.5 Wood Units with v wave less than twice the mean of the pulmonary capillary wedge pressure * Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non ischemic etiology * Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis) * Hemodynamic instability requiring inotropic support or mechanical heart assistance. 13. Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction as assessed by site. 14. Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within the last 30days prior to subject registration. 15. Mitral valve orifice area \< 4.0 cm2 assessed by site based on a transthoracic echocardiogram (TTE) within 90 days prior to subject registration. 16. Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip. This evaluation is based on transesophageal echocardiogram (TEE) evaluation of the mitral valve within 180 days prior to subject registration and includes: * Insufficient mobile leaflet available for grasping with the MitraClip device * Evidence of calcification in the grasping area * Presence of a significant cleft in the grasping area * Lack of both primary and secondary chordal support in the grasping area * Leaflet mobility length \< 1 cm 17. Hemodynamic instability defined as systolic pressure \< 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device. 18. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months. 19. Life expectancy \< 12 months due to non-cardiac conditions. 20. Modified Rankin Scale ≥ 4 disability. 21. Status 1 heart transplant or prior orthotopic heart transplantation. 22. Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure. 23. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. 24. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated). 25. Active infections requiring current antibiotic therapy. 26. Subjects in whom transesophageal echocardiography (TEE) is contraindicated or high risk. 27. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically. 28. Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing age should be instructed to use safe contraception (e.g. intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release. 29. Currently participating in an investigational drug or another device study that has not reached its primary endpoint. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. 30. Subject belongs to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures. For the CPX Sub-study: Subjects who have any contraindications to CPX and are not capable of performing CPX per investigator's assessment should not be registered in the CPX Sub-study. COAPT CAS study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint - Percentage of Participants With Freedom From Device Related Complications at 12 Months | 12 months | Percentage of Participants with Freedom from Device related Complications at 12 Months. Composite of Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, and any device related complications requiring non-elective cardiovascular surgery. |
| Primary Effectiveness Endpoint | 24 months | Recurrent HF hospitalizations (HFH) through 24 months, analyzed when the last subject completes 12-month follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QOL) (COAPT CAS Study Analysis) Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) | 12 months | The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physicalfunction, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possiblesubscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies thefollowing six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical FunctionDomain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQSymptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Scoreincludes total symptom and physical function scores to correspond with NYHA Classification. Overall SummaryScore includes the total symptom, physical function, social limitations and quality of life scores. |
| Six Minute Walk Test (6MWT Distance or 6MWD) (COAPT CAS Study Analysis) | 12 months | The Six Minute Walk Test (6MWT) is a practical simple test that requires a 100-ft hallway but no exerciseequipment or advanced training for technicians. This test measures the distance that a patient can quickly walk ona flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of allthe systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation,peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific informationon the function of each of the different organs and systems involved in exercise or the mechanism of exerciselimitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses thesubmaximal level of functional capacity. |
| Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) | 12 months | MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume \< 30 ml, Right ventricular EF \<30%, Effective regurgitant orifice area \< 20 mm\^2 MR2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm\^2 MR3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm\^2MR 4+ - Regurgitant Volume \>= 60 ml, Right ventricular EF \>=50%, Effective regurgitant orifice area \>=40 mm\^2 |
| Major and/or Life Threatening Bleeding (COAPT CAS Study Analysis) | 12 months | — |
| Major Vascular Complications (COAPT CAS Study Analysis) | 12 months | — |
| Renal Complication With Requirement for Dialysis (COAPT CAS Study Analysis) | 12 months | — |
| Transient Ischemic Attack (TIA) (COAPT CAS Study Analysis) | 12 months | — |
| Stroke (COAPT CAS Study Analysis) | 12 months | — |
| Myocardial Infarction (MI) (COAPT CAS Study Analysis) | 12 months | — |
| Death and Primary Cause of Death (COAPT CAS Study Analysis) | 12 months | — |
| Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis) | 12 months | Number of recurrent Heart Failure hospitalization events at 12 months. |
| Number of Deaths at 12 Months (All Cause Mortality) | 12 months | Death from any cause mortality at 12months. |
| Number of Participants With Mitral Regurgitation Severity Grade of 2+ or Lower at 12 Months | 12 months | MR severity grade of 2+ or lower at 12 months MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume \< 30 ml, Right ventricular EF \<30%, Effective regurgitant orifice area \< 20 mm\^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm\^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm\^2 MR 4+ - Regurgitant Volume \>= 60 ml, Right ventricular EF \>=50%, Effective regurgitant orifice area \>=40 mm\^2 |
| Change in Distance Walked on the 6 Minute Walk Test (6MWT Distance or 6MWD) | 12 months over baseline | The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity. |
| Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) | 12 months over baseline | Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 12 month KCCQ score. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores. |
| Change in Left Ventricular End Diastolic Volume (LVEDV) | 12 months over baseline | Paired data comparing the Change in LVEDV at baseline vs 12 months |
| Number of Participants With New York Heart Association (NYHA) Functional Class I/II | 12 months | NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA CLASS) Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. |
| Recurrent Hospitalizations - All Cause | 24 Months | Number of Recurrent Hospitalizations for any cause within 24 months. |
| Death or HF Hospitalization Within 24 Months (Finkelstein-Schoenfeld Analysis of All-Cause Death or Recurrent HF Hospitalization Through 24 Months) | 24 months | The win ratio is a useful method for providing an estimate of the treatment effect when composite endpoints are analyzed as the analysis accounts for clinical significance of the outcomes of interest. For example, in the composite of death and recurrent HF hospitalizations through 24 months, subjects in the Device and Control groups were formed into matched pairs, where each pair of subjects was classified into 1 of 5 outcomes scenarios: A. Death in Device group first B. Death in Control group first C. More HF hospitalizations in the Device group (or in the case of a tie, the first HF hospitalization in the Device group occurs first) D. More HF hospitalization in the Control group (or in the case of tie, the first HF hospitalization in the Control group occurs first) E. None of the above In this way, the number of Winners in the Device group was NW = NB + ND while the number of Losers in the Device group was NL = NA + NC. The Win Ratio was then calculated as NW/NL. |
| Kaplan-Meier Freedom From All-cause Mortality | 24 months | Death from any cause within 24 months - no of events |
| Percentage of Patients Free From the Composite of All-cause Death, Stroke, MI, or Non-elective Cardiovascular Surgery for Device Related Complications in the Device Group | 30 days post-procedure in the Device group | The percentage of patients free from the composite endpoint as described above. |
| New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis) | 12 months | The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms Class IV - Severe limitations. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Kaplan-Meier Freedom From the Primary Safety Composite | 24 months in Device group | Freedom from the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety. |
| Kaplan-Meier Freedom From All-cause Mortality | 24 months | Kaplan-Meier survival rate for all cause mortality at 24 months |
| Kaplan-Meier Freedom From Cardiovascular Mortality | 12 months | Kaplan-Meier survival rate for Cardiovascular mortality. |
| Kaplan-Meier Freedom From the First HF Related Hospitalization | 12 months | — |
| Kaplan-Meier Freedom From the First Cardiovascular Hospitalization | 12 months | — |
| Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality | 12 months | — |
| NYHA Functional Class | Baseline | Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations |
| Six-Minute Walk Test Distance (6MWD) | Baseline | Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. |
| 6MWD | 30 days | Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise. |
| Change in 6MWD From Baseline | Between baseline and 30 days | — |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores | Baseline | The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores. |
| New Onset of Permanent Atrial Fibrillation | 12 months | — |
| KCCQ QoL Scores | 30 days | The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores. |
| Change in KCCQ QoL Scores From Baseline | Between baseline and 30 days | Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 30 days KCCQ score. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores. |
| SF-36 QoL Scores | Baseline | The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS). |
| Mitral Stenosis | 12 months | Defined as a mitral valve orifice area of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory |
| Change in SF-36 QoL Scores From Baseline | Between baseline and 30 days | Paired data looking at difference between the baseline SF-36 and 30 days SF-36. The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS). |
| Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group | Through 5 years | — |
| De Novo MitraClip Device Intervention in Control Group | Through 5 years | — |
| Responder Analysis for 6MWD | 12 months | Where responder is defined as alive and experiencing an improvement of 24 meters and 50 meters (difference in proportion of responders between Device and Control groups) |
| Responder Analysis for LVEDV Index | 12 months | Where responder is defined as alive and experiencing an improvement of 12 ml/m2 (difference in proportion of responders between Device and Control groups) |
| Responder Analysis for QoL (KCCQ) | 12 months | Where responder is defined as alive and experiencing an improvement of 5 points (difference in proportion of responders between Device and Control groups) |
| Each Subscale for QoL (KCCQ) | 12 months | difference in means between Device and Control groups for the Kansas City Cardiomyopathy Questionnaire (KCCQ) for the physical limitation and symptom stability scores. |
| Length of Index Hospitalization for MitraClip Procedure (Device Group) | Before MitraClip procedure on day 0 | Length of stay in the hospital for the MitraClip Index procedure (device group) |
| Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular) | 12 months | in each of the Device and Control groups |
| Number of Days Alive and Out of Hospital | From the time of randomization to 12 months | mean no of days alive and out of hospital in both Device and Control groups |
| Number of Days Hospitalized From the Treatment Visit | 12 months | mean Number of days hospitalized from the Treatment visit for the Device and Control groups |
| Proportion of Alive Time in Hospital | 12 months | summarized and compared between Device and Control groups |
| Proportion of Subjects Living in the Baseline Location | 12 months | Subjects living in the baseline location include : home, retirement home, nursing facility and other location. |
| Device-related Complications in Device Group Subjects and Control Group Subjects Who Undergo the MitraClip Procedure | Through 5 years | — |
| Brain Natriuretic Peptide (BNP) or N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels) | Baseline | — |
| BNP or NT-proBNP Levels | 30 days | — |
| Modified Rankin Scale Score | Baseline | MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead |
| Major Bleeding | 30 days | Major bleeding is defined as bleeding ≥ Type 3 based on a modified Bleeding Academic Research Consortium (BARC) definition |
| Prolonged Ventilation | 30 days | Defined as pulmonary insufficiency requiring ventilatory support for greater than 48 hours post-catheterization |
| Average Dosages of Guideline Directed Medical Therapy (GDMT) | Baseline | — |
| Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention | 12 months | — |
| The Number of Subjects With Changes in GDMT Dosage From Baseline | Between baseline and 30 days | — |
| The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months | Between baseline and 6 months | — |
| The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months | Between baseline and 12 months | — |
| The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months | Between baseline and 24 months | — |
| The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Between baseline and 3 years | — |
| The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Between baseline and 30 days | — |
| The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Between baseline and 6 months | — |
| The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Between baseline and 3 years | — |
| Cardiopulmonary Exercise (CPX) Testing | Baseline | A substudy endpoint will utilize peak oxygen consumption oxygen uptake (VO2) as a parameter for cardiopulmonary exercise testing on a total of at least 50 and up to 100 subjects. The CPX analysis variables are: * Peak VO2 (ml/kg/min) - CPX Sub-study endpoint, descriptive analysis only, not powered for statistical significance * Exercise duration (min) * Peak workload (watts) * Maximum heart rate during exercise (beats/min) * Peak VE (l/min) * Respiratory Exchange Ratio (RER, VCO2/VO2) * VE/VCO2 slope * Ventilatory Threshold (ml/kg/min) * Borg scale * Exercise termination reason * Type of exercise (treadmill vs cycling) |
| Cardiopulmonary Exercise (CPX) Testing: Mean Changes in Peak VO2 | Between baseline and 12 months | Mean changes in peak VO2 (ml/kg/min) will be summarized at 12 months from baseline for the subset of patients who complete a CPX test at baseline and 12 months. A comparison of change from baseline between Device and Control groups will be presented. The CPX analysis variables are: * Peak VO2 (ml/kg/min) - CPX Sub-study endpoint, descriptive analysis only, not powered for statistical significance * Exercise duration (min) * Peak workload (watts) * Maximum heart rate during exercise (beats/min) * Peak VE (l/min) * Respiratory Exchange Ratio (RER, VCO2/VO2) * VE/VCO2 slope * Ventilatory Threshold (ml/kg/min) * Borg scale * Exercise termination reason * Type of exercise (treadmill vs cycling) |
| Health Economic Data | Through 5 years | — |
| Average Dosages of GDMT | 30 days | — |
| Mitral Valve Replacement Rates | 12 months | Subjects with mitral valve replacements in the Device and Control groups |
| Device or Procedure-Related Adverse Events | Within and after 30 days of the procedure | Device or procedure-related adverse events are defined as adverse events that are adjudicated by the Clinical Events Committee as possibly, probably or definitely device and/or procedure-related, regardless of the temporal relationship to the MitraClip procedure. Device or procedure-related adverse events will be broken down into those that occur within 30 days of the procedure and those that occur after 30 days of the procedure. Examples of device-related adverse events are: myocardial perforation, Single Leaflet Device Attachment, embolization of the MitraClip device or MitraClip System components, iatrogenic atrial septal defect, mitral valve stenosis, need for mitral valve replacement instead of repair due at least in part to the MitraClip procedure or the presence of the MitraClip device. |
| Implant Rate | Day 0 | Defined as the rate of successful delivery and deployment of the MitraClip device(s) with echocardiographic evidence of leaflet approximation and retrieval of the delivery catheter |
| Device Procedure Time | Day 0 | Defined as the time elapsed from the start of the transseptal procedure to the time the Steerable Guide Catheter is removed |
| Total Procedure Time | Day 0 | Defined as the time elapsed from the first of any of the following: intravascular catheter placement, anesthesia or sedation, or transesophageal echocardiogram (TEE), to the removal of the last catheter and TEE |
| Device Time | Day 0 | Defined as the time the Steerable Guide Catheter is placed in the intra-atrial septum until the time the MitraClip Delivery System (CDS) is retracted into the Steerable Guide Catheter |
| Fluoroscopy Duration | Day 0 | Defined as the duration of exposure to fluoroscopy during the MitraClip procedure |
| MR Severity Grade | Baseline | MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume \< 30 ml, Right ventricular EF \<30%, Effective regurgitant orifice area \< 20 mm\^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm\^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm\^2 MR 4+ - Regurgitant Volume \>= 60 ml, Right ventricular EF \>=50%, Effective regurgitant orifice area \>=40 mm\^2 |
| Effective Regurgitant Orifice Area | Baseline | Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity |
| Regurgitant Volume | Baseline | Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole. |
| Regurgitant Fraction | Baseline | Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency. |
| Left Ventricle End Diastolic Volume (LVEDV) | Baseline | Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts. |
| Left Ventricular End Systolic Volume (LVESV) | Baseline | Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle. |
| Left Ventricular End Diastolic Dimension (LVEDD) | Baseline | — |
| Left Ventricular End Systolic Dimension (LVESD) | Baseline | — |
| Left Ventricular Ejection Fraction (LVEF) | Baseline | — |
| Right Ventricular Systolic Pressure (RVSP) | Baseline | — |
| Mitral Valve Area | Baseline | — |
| Mean Mitral Valve Gradient | Baseline | The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output. |
| Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Baseline | — |
| Cardiac Output | Baseline | The amount of blood the heart pumps through the circulatory system in a minute. |
| Forward Stroke Volume | Baseline | Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume. |
| Kaplan-Meier Freedom From the Components of the Primary Safety Composite | 12 months in Device group | Freedom from the components of the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety. |
Countries
Canada, United States
Participant flow
Recruitment details
In COAPT, 614 subjects were randomized. Enrollment concluded on June 23, 2017. Of the 614 randomized subjects, 302 were in Device group and 312 in the Control group. Subject follow-up is complete in the COAPT IDE study. In COAPT CAS Group, 162 new subjects were enrolled. All 162 subjects received MitraClip device. Enrollment concluded in March 2019. Subject follow-up is on-going in the COAPT CAS study. Total enrollment = 614 (COAPT = 302 MitraClip + 314 Control) + 162 (COAPT CAS) = 776
Pre-assignment details
This section includes the results for the primary safety, primary effectiveness, and the 10 secondary endpoints that are the most essential outcomes of the COAPT trial and also the Primary safety, primary effectiveness and other endpoints for the COAPT CAS Group.
Participants by arm
| Arm | Count |
|---|---|
| MitraClip System Percutaneous mitral valve repair using MitraClip System
MitraClip System: Percutaneous mitral valve repair using MitraClip System | 302 |
| Control Group Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice. | 312 |
| COAPT CAS Group subjects who received Percutaneous mitral valve repair using MitraClip System in the COAPT continued access study (CAS) group. | 162 |
| Total | 776 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 167 | 192 | 39 |
| Overall Study | Lost to Follow-up | 7 | 4 | 2 |
| Overall Study | Missed Visits | 1 | 4 | 6 |
| Overall Study | Withdrawal by Subject | 23 | 37 | 5 |
Baseline characteristics
| Characteristic | MitraClip System | Control Group | COAPT CAS Group | Total |
|---|---|---|---|---|
| Age, Continuous | 71.7 years STANDARD_DEVIATION 11.8 | 72.8 years STANDARD_DEVIATION 10.5 | 74.5 years STANDARD_DEVIATION 10.3 | 72.2 years STANDARD_DEVIATION 11.2 |
| Anemia | 180 Participants | 192 Participants | 0 Participants | 372 Participants |
| Body Mass Index (kg/m^2) | 27.04 Kg/m^2 STANDARD_DEVIATION 5.81 | 27.05 Kg/m^2 STANDARD_DEVIATION 5.96 | 26.93 Kg/m^2 STANDARD_DEVIATION 5.63 | 27.05 Kg/m^2 STANDARD_DEVIATION 5.88 |
| Brain Natriuretic Peptide (Pg/mL) | 1014.77 Pg/mL STANDARD_DEVIATION 1085.98 | 1017.13 Pg/mL STANDARD_DEVIATION 1212.77 | 1224.2 Pg/mL STANDARD_DEVIATION 1270.4 | 1015.95 Pg/mL STANDARD_DEVIATION 1149.89 |
| Cardiomyopathy Ischemic | 184 Participants | 189 Participants | 73 Participants | 446 Participants |
| Cardiomyopathy Non-Ischemic | 118 Participants | 123 Participants | 66 Participants | 307 Participants |
| Chronic Obstructive Pulmonary Disease | 71 Participants | 72 Participants | 0 Participants | 143 Participants |
| Creatinine Clearance <= 60mL/min | 214 Participants | 227 Participants | 0 Participants | 441 Participants |
| Creatinine Clearance (mL/min) | 50.87 mL/min STANDARD_DEVIATION 28.48 | 47.76 mL/min STANDARD_DEVIATION 24.97 | 0 mL/min STANDARD_DEVIATION 0 | 49.31 mL/min STANDARD_DEVIATION 26.79 |
| Diabetes | 106 Participants | 123 Participants | 51 Participants | 280 Participants |
| Effective Regurgitat Orifice Area | 0.41 Cm2 STANDARD_DEVIATION 0.15 | 0.40 Cm2 STANDARD_DEVIATION 0.15 | 0.70 Cm2 STANDARD_DEVIATION 1.16 | 0.41 Cm2 STANDARD_DEVIATION 0.15 |
| Elevated BNP or NT-BNP prior to Enrollment | 267 Participants | 282 Participants | 0 Participants | 549 Participants |
| Extremely High Risk for MV Surgery | 205 Participants | 218 Participants | 0 Participants | 423 Participants |
| Height | 170.84 Cm STANDARD_DEVIATION 10.35 | 169.86 Cm STANDARD_DEVIATION 10.75 | 171.11 Cm STANDARD_DEVIATION 10.38 | 170.34 Cm STANDARD_DEVIATION 10.56 |
| History of Atrial Fibrillation or Flutter | 173 Participants | 166 Participants | 99 Participants | 438 Participants |
| Hospitalization for Heart Failure within Previous 1 yr | 176 Participants | 175 Participants | 105 Participants | 456 Participants |
| Hypercholesterolemia | 166 Participants | 163 Participants | 0 Participants | 329 Participants |
| Hypertension | 243 Participants | 251 Participants | 137 Participants | 631 Participants |
| Left Ventricular Ejection Fraction | 31.32 % STANDARD_DEVIATION 9.07 | 31.30 % STANDARD_DEVIATION 9.58 | 32.2 % STANDARD_DEVIATION 9.9 | 31.31 % STANDARD_DEVIATION 9.32 |
| Left Ventricular End-Diastolic Dimension | 6.17 cm STANDARD_DEVIATION 0.73 | 6.19 cm STANDARD_DEVIATION 0.75 | 6.23 cm STANDARD_DEVIATION 0.86 | 6.18 cm STANDARD_DEVIATION 0.74 |
| Left Ventricular End-Diastolic Volume | 194.4 mL STANDARD_DEVIATION 69.2 | 191.0 mL STANDARD_DEVIATION 72.9 | 185.8 mL STANDARD_DEVIATION 81.2 | 192.7 mL STANDARD_DEVIATION 71 |
| Left Ventricular End Systolic Dimension (Diameter) | 5.28 cm STANDARD_DEVIATION 0.86 | 5.30 cm STANDARD_DEVIATION 0.89 | 1.16 cm STANDARD_DEVIATION 0.95 | 5.29 cm STANDARD_DEVIATION 0.87 |
| Left Ventricular End-Systolic Volume | 135.5 mL STANDARD_DEVIATION 56.1 | 134.3 mL STANDARD_DEVIATION 60.3 | 132.3 mL STANDARD_DEVIATION 65.4 | 134.9 mL STANDARD_DEVIATION 58.2 |
| LVEF >= 40% | 231 Participants | 241 Participants | 28 Participants | 500 Participants |
| New York Heart Association (NYHA) Classification NYHA Class I | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| New York Heart Association (NYHA) Classification NYHA Class II | 129 Participants | 110 Participants | 30 Participants | 269 Participants |
| New York Heart Association (NYHA) Classification NYHA Class III | 154 Participants | 168 Participants | 111 Participants | 433 Participants |
| New York Heart Association (NYHA) Classification NYHA Class IVa, ambulatory | 18 Participants | 33 Participants | 21 Participants | 72 Participants |
| NT-proBNP (pg/mL) | 5174.33 pg/mL STANDARD_DEVIATION 6566.61 | 5943.86 pg/mL STANDARD_DEVIATION 8437.61 | 6885.3 pg/mL STANDARD_DEVIATION 8287 | 5585.71 pg/mL STANDARD_DEVIATION 7610.56 |
| Peripheral Vascular Disease | 52 Participants | 57 Participants | 34 Participants | 143 Participants |
| Previous Cardiac Resynchronization Therapy | 115 Participants | 109 Participants | 25 Participants | 249 Participants |
| Previous Coronary Artery Bypass Grafting | 121 Participants | 126 Participants | 51 Participants | 298 Participants |
| Previous Implantation of Defibrillator | 91 Participants | 101 Participants | 95 Participants | 287 Participants |
| Previous Myocardial Infarction | 156 Participants | 160 Participants | 65 Participants | 381 Participants |
| Previous Percutaneous Coronary Intervention | 130 Participants | 153 Participants | 63 Participants | 346 Participants |
| Previous Stroke or Transient Ischemic Attack | 56 Participants | 49 Participants | 9 Participants | 114 Participants |
| Race/Ethnicity, Customized Race/Ethnicity American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 6 Participants | 12 Participants | 5 Participants | 23 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black or African American | 44 Participants | 44 Participants | 28 Participants | 116 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic or Latino | 20 Participants | 20 Participants | 0 Participants | 40 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 6 Participants | 4 Participants | 0 Participants | 10 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White or Caucasian | 225 Participants | 232 Participants | 129 Participants | 586 Participants |
| Region of Enrollment Canada | 12 participants | 14 participants | 0 participants | 26 participants |
| Region of Enrollment United States | 290 participants | 298 participants | 162 participants | 588 participants |
| Right Ventricular Systolic Pressure | 43.95 mmHg STANDARD_DEVIATION 13.44 | 44.56 mmHg STANDARD_DEVIATION 13.96 | 0 mmHg STANDARD_DEVIATION 0 | 44.26 mmHg STANDARD_DEVIATION 13.7 |
| Risk of Surgery-related complications or death High | 205 Participants | 218 Participants | 0 Participants | 423 Participants |
| Risk of Surgery-related complications or death Not High | 94 Participants | 94 Participants | 0 Participants | 188 Participants |
| Serum Creatinine (mg/dL) | 1.77 (mg/dL) STANDARD_DEVIATION 1.22 | 1.80 (mg/dL) STANDARD_DEVIATION 1.42 | 1.93 (mg/dL) STANDARD_DEVIATION 1.54 | 1.79 (mg/dL) STANDARD_DEVIATION 1.32 |
| Severity of Mitral Regurgitation Moderate-to-severe, grade 3+ | 148 Participants | 172 Participants | 54 Participants | 374 Participants |
| Severity of Mitral Regurgitation Severe, grade 4+ | 154 Participants | 139 Participants | 99 Participants | 392 Participants |
| Sex: Female, Male Female | 101 Participants | 120 Participants | 57 Participants | 278 Participants |
| Sex: Female, Male Male | 201 Participants | 192 Participants | 105 Participants | 498 Participants |
| STS Risk Score | 7.83 percentage of expected mortality STANDARD_DEVIATION 5.53 | 8.5 percentage of expected mortality STANDARD_DEVIATION 6.15 | 9.26 percentage of expected mortality STANDARD_DEVIATION 6.39 | 8.17 percentage of expected mortality STANDARD_DEVIATION 5.86 |
| STS Risk Score >= 8% | 126 Participants | 136 Participants | 78 Participants | 340 Participants |
| Weight | 78.79 Kg STANDARD_DEVIATION 17.23 | 78.40 Kg STANDARD_DEVIATION 20.06 | 79.08 Kg STANDARD_DEVIATION 18.76 | 78.59 Kg STANDARD_DEVIATION 18.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 167 / 302 | 192 / 312 | 46 / 162 |
| other Total, other adverse events | 239 / 302 | 234 / 312 | 86 / 162 |
| serious Total, serious adverse events | 281 / 302 | 291 / 312 | 0 / 0 |
Outcome results
Primary
Primary Effectiveness Endpoint
Recurrent HF hospitalizations (HFH) through 24 months, analyzed when the last subject completes 12-month follow-up
Time frame: 24 months
Population: 302 subjects from device group and 312 subjects from the control group were analyzed for Recurrent HF hospitalizations through 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Primary Effectiveness Endpoint | 160 events |
| Control Group | Primary Effectiveness Endpoint | 283 events |
Primary
Primary Effectiveness Endpoint
Recurrent HF hospitalizations (HFH) through 24 months, analyzed when the last subject completes 12-month follow-up
Time frame: 24 months
Population: 302 subjects from device group and 312 subjects from the control group were analyzed for Recurrent HF hospitalizations through 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Primary Effectiveness Endpoint | 92 Participants |
| Control Group | Primary Effectiveness Endpoint | 151 Participants |
Primary
Primary Safety Endpoint - Percentage of Participants With Freedom From Device Related Complications at 12 Months
Percentage of Participants with Freedom from Device related Complications at 12 Months. Composite of Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, and any device related complications requiring non-elective cardiovascular surgery.
Time frame: 12 months
Population: Subjects who were randomized with attempted procedure to the device group with available data. Performance goal was 88%.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Primary Safety Endpoint - Percentage of Participants With Freedom From Device Related Complications at 12 Months | 0.966 percentage of participants |
p-value: <0.0001Z test Using Kaplan Meier Survival
Secondary
Change in Distance Walked on the 6 Minute Walk Test (6MWT Distance or 6MWD)
The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Time frame: 12 months over baseline
Population: Analysis population includes subjects still active and with paired available compared to baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Change in Distance Walked on the 6 Minute Walk Test (6MWT Distance or 6MWD) | -2.17 meters | Standard Deviation 9.12 |
| Control Group | Change in Distance Walked on the 6 Minute Walk Test (6MWT Distance or 6MWD) | -60.2 meters | Standard Deviation 8.99 |
Secondary
Change in Left Ventricular End Diastolic Volume (LVEDV)
Paired data comparing the Change in LVEDV at baseline vs 12 months
Time frame: 12 months over baseline
Population: Analysis population includes subjects with echocardiography paired data available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Change in Left Ventricular End Diastolic Volume (LVEDV) | -3.71 mL | Standard Deviation 5.08 |
| Control Group | Change in Left Ventricular End Diastolic Volume (LVEDV) | 17.06 mL | Standard Deviation 5.1 |
Secondary
Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 12 month KCCQ score. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time frame: 12 months over baseline
Population: Analysis population includes subjects still active and with paired available compared to baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) | 12.5 KCCQ Score on a points scale | Standard Deviation 1.8 |
| Control Group | Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) | -3.6 KCCQ Score on a points scale | Standard Deviation 1.9 |
Secondary
Death and Primary Cause of Death (COAPT CAS Study Analysis)
Time frame: 3 years
Secondary
Death and Primary Cause of Death (COAPT CAS Study Analysis)
The COAPT study is still on-going. Only the Primary and major secondary endpoints have been entered. Rest of the results will be entered when the study ends in July 2024.
Time frame: 2 years
Secondary
Death and Primary Cause of Death (COAPT CAS Study Analysis)
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Death and Primary Cause of Death (COAPT CAS Study Analysis) | Valvular | 0 Participants |
| MitraClip System | Death and Primary Cause of Death (COAPT CAS Study Analysis) | Cardiac | 13 Participants |
| MitraClip System | Death and Primary Cause of Death (COAPT CAS Study Analysis) | Neurologic | 2 Participants |
| MitraClip System | Death and Primary Cause of Death (COAPT CAS Study Analysis) | Renal | 0 Participants |
| MitraClip System | Death and Primary Cause of Death (COAPT CAS Study Analysis) | Vascular | 0 Participants |
| MitraClip System | Death and Primary Cause of Death (COAPT CAS Study Analysis) | Infection | 1 Participants |
| MitraClip System | Death and Primary Cause of Death (COAPT CAS Study Analysis) | Unknown | 24 Participants |
| MitraClip System | Death and Primary Cause of Death (COAPT CAS Study Analysis) | Other | 1 Participants |
| MitraClip System | Death and Primary Cause of Death (COAPT CAS Study Analysis) | Not Available | 1 Participants |
Secondary
Death and Primary Cause of Death (COAPT CAS Study Analysis)
Time frame: 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Death and Primary Cause of Death (COAPT CAS Study Analysis) | Cardiac | 2 Participants |
| MitraClip System | Death and Primary Cause of Death (COAPT CAS Study Analysis) | Neurologic | 0 Participants |
| MitraClip System | Death and Primary Cause of Death (COAPT CAS Study Analysis) | Renal | 0 Participants |
| MitraClip System | Death and Primary Cause of Death (COAPT CAS Study Analysis) | Vascular | 0 Participants |
| MitraClip System | Death and Primary Cause of Death (COAPT CAS Study Analysis) | Infection | 0 Participants |
| MitraClip System | Death and Primary Cause of Death (COAPT CAS Study Analysis) | Valvular | 0 Participants |
| MitraClip System | Death and Primary Cause of Death (COAPT CAS Study Analysis) | Unknown | 1 Participants |
| MitraClip System | Death and Primary Cause of Death (COAPT CAS Study Analysis) | Other | 0 Participants |
Secondary
Death and Primary Cause of Death (COAPT CAS Study Analysis)
Time frame: 5 years
Secondary
Death and Primary Cause of Death (COAPT CAS Study Analysis)
Time frame: 4 years
Secondary
Death or HF Hospitalization Within 24 Months (Finkelstein-Schoenfeld Analysis of All-Cause Death or Recurrent HF Hospitalization Through 24 Months)
The win ratio is a useful method for providing an estimate of the treatment effect when composite endpoints are analyzed as the analysis accounts for clinical significance of the outcomes of interest. For example, in the composite of death and recurrent HF hospitalizations through 24 months, subjects in the Device and Control groups were formed into matched pairs, where each pair of subjects was classified into 1 of 5 outcomes scenarios: A. Death in Device group first B. Death in Control group first C. More HF hospitalizations in the Device group (or in the case of a tie, the first HF hospitalization in the Device group occurs first) D. More HF hospitalization in the Control group (or in the case of tie, the first HF hospitalization in the Control group occurs first) E. None of the above In this way, the number of Winners in the Device group was NW = NB + ND while the number of Losers in the Device group was NL = NA + NC. The Win Ratio was then calculated as NW/NL.
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Death or HF Hospitalization Within 24 Months (Finkelstein-Schoenfeld Analysis of All-Cause Death or Recurrent HF Hospitalization Through 24 Months) | 1.61 Win Ratio |
p-value: <0.000195% CI: [1.29, 2.04]Finkelstein-Schoenfeld Analysis
Secondary
Kaplan-Meier Freedom From All-cause Mortality
Death from any cause within 24 months - no of events
Time frame: 24 months
Population: Total number of subjects randomized in the Device and Control group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From All-cause Mortality | 83 no of events |
| Control Group | Kaplan-Meier Freedom From All-cause Mortality | 125 no of events |
Secondary
Major and/or Life Threatening Bleeding (COAPT CAS Study Analysis)
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Major and/or Life Threatening Bleeding (COAPT CAS Study Analysis) | 1 Participants |
Secondary
Major and/or Life Threatening Bleeding (COAPT CAS Study Analysis)
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Major and/or Life Threatening Bleeding (COAPT CAS Study Analysis) | 4 Participants |
Secondary
Major Vascular Complications (COAPT CAS Study Analysis)
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Major Vascular Complications (COAPT CAS Study Analysis) | 1 Participants |
Secondary
Major Vascular Complications (COAPT CAS Study Analysis)
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Major Vascular Complications (COAPT CAS Study Analysis) | 0 Participants |
Secondary
Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis)
MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume \< 30 ml, Right ventricular EF \<30%, Effective regurgitant orifice area \< 20 mm\^2 MR2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm\^2 MR3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm\^2MR 4+ - Regurgitant Volume \>= 60 ml, Right ventricular EF \>=50%, Effective regurgitant orifice area \>=40 mm\^2
Time frame: 12 months
Population: Echocardiogram data was available for 98 subjects at 12 months.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) | None or Trace/Trivial | 9 Participants |
| MitraClip System | Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) | Mild (1+) | 53 Participants |
| MitraClip System | Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) | Moderate (2+) | 27 Participants |
| MitraClip System | Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) | Moderate - Severe (3+) | 6 Participants |
| MitraClip System | Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) | Severe (4+) | 3 Participants |
Secondary
Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis)
MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume \< 30 ml, Right ventricular EF \<30%, Effective regurgitant orifice area \< 20 mm\^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm\^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm\^2 MR 4+ - Regurgitant Volume \>= 60 ml, Right ventricular EF \>=50%, Effective regurgitant orifice area \>=40 mm\^2
Time frame: 30 days
Population: Echocardiogram data was available for 149 subjects at 30 days.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) | None or Trace/Trivial | 11 Participants |
| MitraClip System | Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) | Mild (1+) | 85 Participants |
| MitraClip System | Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) | Moderate (2+) | 40 Participants |
| MitraClip System | Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) | Moderate - Severe (3+) | 9 Participants |
| MitraClip System | Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis) | Severe (4+) | 4 Participants |
Secondary
Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Time frame: 2 years
Secondary
Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Myocardial Infarction (MI) (COAPT CAS Study Analysis) | 0 Participants |
Secondary
Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Time frame: 5 years
Secondary
Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Time frame: 4 years
Secondary
Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Time frame: 3 years
Secondary
Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Myocardial Infarction (MI) (COAPT CAS Study Analysis) | 0 Participants |
Secondary
New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis)
The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms Class IV - Severe limitations.
Time frame: 30 days
Population: A total of 162 subjects were enrolled in the COAPT CAS study. Of them NYHA data was available for a total of 142 subjects at 30 days.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis) | NYHA Class I | 30 Participants |
| MitraClip System | New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis) | NYHA Class II | 66 Participants |
| MitraClip System | New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis) | NYHA Class III | 43 Participants |
| MitraClip System | New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis) | NYHA Class IV | 3 Participants |
Secondary
New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis)
The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms Class IV - Severe limitations.
Time frame: 12 months
Population: A total of 162 subjects were enrolled in the COAPT CAS study. Of them NYHA data was available for a total of 93 subjects at 12 months.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis) | NYHA Class I | 21 Participants |
| MitraClip System | New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis) | NYHA Class II | 44 Participants |
| MitraClip System | New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis) | NYHA Class III | 23 Participants |
| MitraClip System | New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis) | NYHA Class IV | 5 Participants |
Secondary
Number of Deaths at 12 Months (All Cause Mortality)
Death from any cause mortality at 12months.
Time frame: 12 months
Population: All device and control group subjects were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Number of Deaths at 12 Months (All Cause Mortality) | 57 participants |
| Control Group | Number of Deaths at 12 Months (All Cause Mortality) | 70 participants |
Secondary
Number of Participants With Mitral Regurgitation Severity Grade of 2+ or Lower at 12 Months
MR severity grade of 2+ or lower at 12 months MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume \< 30 ml, Right ventricular EF \<30%, Effective regurgitant orifice area \< 20 mm\^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm\^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm\^2 MR 4+ - Regurgitant Volume \>= 60 ml, Right ventricular EF \>=50%, Effective regurgitant orifice area \>=40 mm\^2
Time frame: 12 months
Population: Echocardiography data was available for 210 subjects in Device group and 175 subjects in Control group
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Number of Participants With Mitral Regurgitation Severity Grade of 2+ or Lower at 12 Months | 199 Participants |
| Control Group | Number of Participants With Mitral Regurgitation Severity Grade of 2+ or Lower at 12 Months | 82 Participants |
Secondary
Number of Participants With New York Heart Association (NYHA) Functional Class I/II
NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA CLASS) Class I: Patients with cardiac disease but without resulting limitations of physical activity. Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time frame: 12 months
Population: Analysis population includes subjects with available NYHA class data at 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Number of Participants With New York Heart Association (NYHA) Functional Class I/II | 171 Participants |
| Control Group | Number of Participants With New York Heart Association (NYHA) Functional Class I/II | 115 Participants |
Secondary
Percentage of Patients Free From the Composite of All-cause Death, Stroke, MI, or Non-elective Cardiovascular Surgery for Device Related Complications in the Device Group
The percentage of patients free from the composite endpoint as described above.
Time frame: 30 days post-procedure in the Device group
Population: All device subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Percentage of Patients Free From the Composite of All-cause Death, Stroke, MI, or Non-elective Cardiovascular Surgery for Device Related Complications in the Device Group | 96.9 Percentage of Participants |
Secondary
Quality of Life (QOL) (COAPT CAS Study Analysis) Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physicalfunction, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possiblesubscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies thefollowing six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical FunctionDomain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQSymptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Scoreincludes total symptom and physical function scores to correspond with NYHA Classification. Overall SummaryScore includes the total symptom, physical function, social limitations and quality of life scores.
Time frame: 12 months
Population: A total of 162 subjects were enrolled in the COAPT CAS study. Data was available for 93 subjects at 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Quality of Life (QOL) (COAPT CAS Study Analysis) Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) | 65.93 KCCQ Score on a points scale | Standard Deviation 23.8 |
Secondary
Quality of Life (QOL) (COAPT CAS Study Analysis) Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time frame: 30 days
Population: A total of 162 subjects were enrolled in the COAPT CAS study. Data was available for 143 subjects at 30 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Quality of Life (QOL) (COAPT CAS Study Analysis) Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) | 61.36 KCCQ score on a points scale | Standard Deviation 25 |
Secondary
Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)
Time frame: 5 years
Secondary
Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)
Time frame: 3 years
Secondary
Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)
Time frame: 2 years
Secondary
Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)
Number of recurrent Heart Failure hospitalization events at 12 months.
Time frame: 12 months
Population: A total of 162 subjects were enrolled in the COAPT CAS study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis) | 52 Events |
Secondary
Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)
Time frame: 4 years
Secondary
Recurrent Hospitalizations - All Cause
Number of Recurrent Hospitalizations for any cause within 24 months.
Time frame: 24 Months
Population: All randomized subjects in Device and Control Group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Recurrent Hospitalizations - All Cause | 474 Number of Events |
| Control Group | Recurrent Hospitalizations - All Cause | 610 Number of Events |
p-value: <0.0295% CI: [0.6, 0.96]Joint Fraility Model
Secondary
Renal Complication With Requirement for Dialysis (COAPT CAS Study Analysis)
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Renal Complication With Requirement for Dialysis (COAPT CAS Study Analysis) | 4 Participants |
Secondary
Renal Complication With Requirement for Dialysis (COAPT CAS Study Analysis)
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Renal Complication With Requirement for Dialysis (COAPT CAS Study Analysis) | 2 Participants |
Secondary
Six Minute Walk Test (6MWT Distance or 6MWD) (COAPT CAS Study Analysis)
The Six Minute Walk Test (6MWT) is a practical simple test that requires a 100-ft hallway but no exerciseequipment or advanced training for technicians. This test measures the distance that a patient can quickly walk ona flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of allthe systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation,peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific informationon the function of each of the different organs and systems involved in exercise or the mechanism of exerciselimitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses thesubmaximal level of functional capacity.
Time frame: 12 months
Population: A total of 162 subjects were enrolled in the COAPT CAS study. 6MWT data was available for 72 subjects at 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Six Minute Walk Test (6MWT Distance or 6MWD) (COAPT CAS Study Analysis) | 219.87 meters | Standard Deviation 124.82 |
Secondary
Six Minute Walk Test (6MWT Distance or 6MWD) (COAPT CAS Study Analysis)
The Six Minute Walk Test (6MWT) is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Time frame: 30 days
Population: A total of 162 subjects were enrolled in the COAPT CAS study. 6MWT data was available for 117 subjects at 30 days..
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Six Minute Walk Test (6MWT Distance or 6MWD) (COAPT CAS Study Analysis) | 231.24 meters | Standard Deviation 145.98 |
Secondary
Stroke (COAPT CAS Study Analysis)
Time frame: 5 years
Secondary
Stroke (COAPT CAS Study Analysis)
Time frame: 3 years
Secondary
Stroke (COAPT CAS Study Analysis)
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Stroke (COAPT CAS Study Analysis) | 1 Participants |
Secondary
Stroke (COAPT CAS Study Analysis)
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Stroke (COAPT CAS Study Analysis) | 1 Participants |
Secondary
Stroke (COAPT CAS Study Analysis)
Time frame: 2 years
Secondary
Stroke (COAPT CAS Study Analysis)
Time frame: 4 years
Secondary
Transient Ischemic Attack (TIA) (COAPT CAS Study Analysis)
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Transient Ischemic Attack (TIA) (COAPT CAS Study Analysis) | 0 Participants |
Secondary
Transient Ischemic Attack (TIA) (COAPT CAS Study Analysis)
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Transient Ischemic Attack (TIA) (COAPT CAS Study Analysis) | 0 Participants |
Other Pre-specified
6MWD
Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | 6MWD | 290.1 meters | Standard Deviation 122.8 |
| Control Group | 6MWD | 243.0 meters | Standard Deviation 121 |
Other Pre-specified
6MWD
Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
Time frame: 12 months
Population: All available 6MWD has been reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | 6MWD | 308.4 meters | Standard Deviation 116.7 |
| Control Group | 6MWD | 269.7 meters | Standard Deviation 133.2 |
Other Pre-specified
6MWD
Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
Time frame: 24 months
Population: All available 6MWD has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | 6MWD | 294.2 meters | Standard Deviation 131.2 |
| Control Group | 6MWD | 273.8 meters | Standard Deviation 142.7 |
Other Pre-specified
6MWD
Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
Time frame: 6 months
Population: All available 6MWD has been reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | 6MWD | 288.6 meters | Standard Deviation 128 |
| Control Group | 6MWD | 253.9 meters | Standard Deviation 126.2 |
Other Pre-specified
Average Dosages of GDMT
Time frame: 6 months
Population: All available data has been reported and includes subjects on the drugs mentioned below. Not all subjects were on all the drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MitraClip System | Average Dosages of GDMT | ACE I | 13.22 mg | Standard Deviation 14.59 |
| MitraClip System | Average Dosages of GDMT | ARB | 13.73 mg | Standard Deviation 8.93 |
| MitraClip System | Average Dosages of GDMT | Aldosterone Antagonists | 24.16 mg | Standard Deviation 11.19 |
| MitraClip System | Average Dosages of GDMT | Beta Blockers | 30.01 mg | Standard Deviation 24.94 |
| MitraClip System | Average Dosages of GDMT | Vasodilators (Nitrate) | 55.48 mg | Standard Deviation 41.64 |
| MitraClip System | Average Dosages of GDMT | Vasodilators (Hydralazine) | 133.82 mg | Standard Deviation 104.93 |
| MitraClip System | Average Dosages of GDMT | ARNI | 10.13 mg | Standard Deviation 8.15 |
| Control Group | Average Dosages of GDMT | Beta Blockers | 28.53 mg | Standard Deviation 25.13 |
| Control Group | Average Dosages of GDMT | ACE I | 12.90 mg | Standard Deviation 12.96 |
| Control Group | Average Dosages of GDMT | Vasodilators (Hydralazine) | 109.01 mg | Standard Deviation 87.22 |
| Control Group | Average Dosages of GDMT | ARB | 12.02 mg | Standard Deviation 8.63 |
| Control Group | Average Dosages of GDMT | Vasodilators (Nitrate) | 48.59 mg | Standard Deviation 34.9 |
| Control Group | Average Dosages of GDMT | Aldosterone Antagonists | 29.42 mg | Standard Deviation 32.68 |
| Control Group | Average Dosages of GDMT | ARNI | 7.68 mg | Standard Deviation 4.71 |
Other Pre-specified
Average Dosages of GDMT
Time frame: 4 years
Population: All available data has been reported
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MitraClip System | Average Dosages of GDMT | Aldosterone Antagonist | 24.37 mg | Standard Deviation 11.84 |
| MitraClip System | Average Dosages of GDMT | Vasodilators (Nitrate) | 51.63 mg | Standard Deviation 40.59 |
| MitraClip System | Average Dosages of GDMT | ARBs | 13.28 mg | Standard Deviation 8.85 |
| MitraClip System | Average Dosages of GDMT | Vasodilators | 129.51 mg | Standard Deviation 93.77 |
| MitraClip System | Average Dosages of GDMT | Beta Blockers | 30.59 mg | Standard Deviation 24.26 |
| MitraClip System | Average Dosages of GDMT | ARN Inhibitors | 11.04 mg | Standard Deviation 7.29 |
| MitraClip System | Average Dosages of GDMT | ACE Inhibitors | 12.10 mg | Standard Deviation 13.08 |
| Control Group | Average Dosages of GDMT | ARN Inhibitors | 9.54 mg | Standard Deviation 5.77 |
| Control Group | Average Dosages of GDMT | ACE Inhibitors | 12.37 mg | Standard Deviation 12.89 |
| Control Group | Average Dosages of GDMT | ARBs | 11.03 mg | Standard Deviation 7.83 |
| Control Group | Average Dosages of GDMT | Aldosterone Antagonist | 29.06 mg | Standard Deviation 31.39 |
| Control Group | Average Dosages of GDMT | Beta Blockers | 27.78 mg | Standard Deviation 23.8 |
| Control Group | Average Dosages of GDMT | Vasodilators (Nitrate) | 44.59 mg | Standard Deviation 32.55 |
| Control Group | Average Dosages of GDMT | Vasodilators | 100.74 mg | Standard Deviation 85.36 |
Other Pre-specified
Average Dosages of GDMT
Time frame: 30 days
Population: All available data has been reported and includes subjects on the drugs mentioned below. Not all subjects were on all the drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MitraClip System | Average Dosages of GDMT | ARN Inhibitors | 13.17 mg | Standard Deviation 11.15 |
| MitraClip System | Average Dosages of GDMT | ACE Inhibitors | 13.61 mg | Standard Deviation 15.01 |
| MitraClip System | Average Dosages of GDMT | Angiotensin Receptor Blockers (ARBs) | 13.68 mg | Standard Deviation 9.34 |
| MitraClip System | Average Dosages of GDMT | Aldosterone Antagonists | 24.21 mg | Standard Deviation 11.56 |
| MitraClip System | Average Dosages of GDMT | Beta Blockers | 30.12 mg | Standard Deviation 24.81 |
| MitraClip System | Average Dosages of GDMT | Vasodilators (Nitrate) | 56.38 mg | Standard Deviation 42.76 |
| MitraClip System | Average Dosages of GDMT | Vasodilators (Hydralazine) | 133.41 mg | Standard Deviation 108.29 |
| Control Group | Average Dosages of GDMT | ARN Inhibitors | 8.85 mg | Standard Deviation 5.98 |
| Control Group | Average Dosages of GDMT | Beta Blockers | 29.25 mg | Standard Deviation 25.26 |
| Control Group | Average Dosages of GDMT | ACE Inhibitors | 13.53 mg | Standard Deviation 13.68 |
| Control Group | Average Dosages of GDMT | Vasodilators (Hydralazine) | 110.53 mg | Standard Deviation 87.72 |
| Control Group | Average Dosages of GDMT | Angiotensin Receptor Blockers (ARBs) | 11.89 mg | Standard Deviation 8.76 |
| Control Group | Average Dosages of GDMT | Vasodilators (Nitrate) | 43.79 mg | Standard Deviation 27.15 |
| Control Group | Average Dosages of GDMT | Aldosterone Antagonists | 29.48 mg | Standard Deviation 34.36 |
Other Pre-specified
Average Dosages of GDMT
Time frame: 12 months
Population: All available data has been reported and includes subjects on the drugs mentioned below. Not all subjects were on all the drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MitraClip System | Average Dosages of GDMT | Aldosterone Antagonists | 24.33 mg | Standard Deviation 12.17 |
| MitraClip System | Average Dosages of GDMT | Vasodilators (Nitrate) | 56.85 mg | Standard Deviation 41.5 |
| MitraClip System | Average Dosages of GDMT | ARBs | 13.76 mg | Standard Deviation 9.21 |
| MitraClip System | Average Dosages of GDMT | Vasodilators (Hydralazine) | 136.51 mg | Standard Deviation 99.05 |
| MitraClip System | Average Dosages of GDMT | Beta Blockers | 30.10 mg | Standard Deviation 24.99 |
| MitraClip System | Average Dosages of GDMT | ARN Inhibitors | 10.36 mg | Standard Deviation 7.57 |
| MitraClip System | Average Dosages of GDMT | ACE Inhibitors | 12.73 mg | Standard Deviation 13.56 |
| Control Group | Average Dosages of GDMT | ARN Inhibitors | 7.99 mg | Standard Deviation 4.51 |
| Control Group | Average Dosages of GDMT | ACE Inhibitors | 12.41 mg | Standard Deviation 12.82 |
| Control Group | Average Dosages of GDMT | ARBs | 11.90 mg | Standard Deviation 8.45 |
| Control Group | Average Dosages of GDMT | Aldosterone Antagonists | 29.45 mg | Standard Deviation 32.58 |
| Control Group | Average Dosages of GDMT | Beta Blockers | 28.19 mg | Standard Deviation 24.65 |
| Control Group | Average Dosages of GDMT | Vasodilators (Nitrate) | 48.56 mg | Standard Deviation 34.95 |
| Control Group | Average Dosages of GDMT | Vasodilators (Hydralazine) | 108.74 mg | Standard Deviation 87.89 |
Other Pre-specified
Average Dosages of GDMT
Time frame: 24 months
Population: All available data has been reported and includes subjects on the drugs mentioned below. Not all subjects were on all the drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MitraClip System | Average Dosages of GDMT | Aldosterone Antagonists | 24.36 mg | Standard Deviation 12.3 |
| MitraClip System | Average Dosages of GDMT | Vasodilators (Nitrate) | 54.81 mg | Standard Deviation 41.5 |
| MitraClip System | Average Dosages of GDMT | ARBs | 13.86 mg | Standard Deviation 9.1 |
| MitraClip System | Average Dosages of GDMT | Vasodilators (Hydralazine) | 135.20 mg | Standard Deviation 97.01 |
| MitraClip System | Average Dosages of GDMT | Beta Blockers | 30.50 mg | Standard Deviation 25.15 |
| MitraClip System | Average Dosages of GDMT | ARN Inhibitors | 10.41 mg | Standard Deviation 7.34 |
| MitraClip System | Average Dosages of GDMT | ACe Inhibitors | 12.35 mg | Standard Deviation 13.36 |
| Control Group | Average Dosages of GDMT | ARN Inhibitors | 8.52 mg | Standard Deviation 5.4 |
| Control Group | Average Dosages of GDMT | ACe Inhibitors | 12.32 mg | Standard Deviation 12.91 |
| Control Group | Average Dosages of GDMT | ARBs | 11.67 mg | Standard Deviation 8.09 |
| Control Group | Average Dosages of GDMT | Aldosterone Antagonists | 28.98 mg | Standard Deviation 32 |
| Control Group | Average Dosages of GDMT | Beta Blockers | 27.66 mg | Standard Deviation 23.7 |
| Control Group | Average Dosages of GDMT | Vasodilators (Nitrate) | 45.53 mg | Standard Deviation 33.3 |
| Control Group | Average Dosages of GDMT | Vasodilators (Hydralazine) | 102.29 mg | Standard Deviation 85.28 |
Other Pre-specified
Average Dosages of GDMT
Time frame: 5 years
Population: All available data has been reported
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MitraClip System | Average Dosages of GDMT | ARN Inhibitors | 11.53 mg | Standard Deviation 7.34 |
| MitraClip System | Average Dosages of GDMT | ARBs | 13.29 mg | Standard Deviation 8.78 |
| MitraClip System | Average Dosages of GDMT | Vasodilators | 130.83 mg | Standard Deviation 93.29 |
| MitraClip System | Average Dosages of GDMT | Aldosterone Antagonist | 24.30 mg | Standard Deviation 11.84 |
| MitraClip System | Average Dosages of GDMT | ACE Inhibitors | 12.02 mg | Standard Deviation 13.03 |
| MitraClip System | Average Dosages of GDMT | Beta Blockers | 30.60 mg | Standard Deviation 24.16 |
| MitraClip System | Average Dosages of GDMT | Vasodilators Nitrate | 52.41 mg | Standard Deviation 40.35 |
| Control Group | Average Dosages of GDMT | Beta Blockers | 27.78 mg | Standard Deviation 23.8 |
| Control Group | Average Dosages of GDMT | Vasodilators Nitrate | 44.28 mg | Standard Deviation 32.27 |
| Control Group | Average Dosages of GDMT | Vasodilators | 100.07 mg | Standard Deviation 84.45 |
| Control Group | Average Dosages of GDMT | ARN Inhibitors | 9.41 mg | Standard Deviation 5.81 |
| Control Group | Average Dosages of GDMT | ACE Inhibitors | 12.35 mg | Standard Deviation 12.88 |
| Control Group | Average Dosages of GDMT | ARBs | 11.02 mg | Standard Deviation 7.82 |
| Control Group | Average Dosages of GDMT | Aldosterone Antagonist | 28.99 mg | Standard Deviation 31.13 |
Other Pre-specified
Average Dosages of GDMT
Time frame: 3 years
Population: All available data has been reported and includes subjects on the drugs mentioned below. Not all subjects were on all thedrugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MitraClip System | Average Dosages of GDMT | Aldosterone Antagonists | 24.24 mg | Standard Deviation 11.91 |
| MitraClip System | Average Dosages of GDMT | Vasodilators (Nitrate) | 53.37 mg | Standard Deviation 41.58 |
| MitraClip System | Average Dosages of GDMT | ARBs | 13.42 mg | Standard Deviation 8.88 |
| MitraClip System | Average Dosages of GDMT | Vasodilators (Hydralazine) | 132.54 mg | Standard Deviation 93.88 |
| MitraClip System | Average Dosages of GDMT | Beta Blockers | 30.70 mg | Standard Deviation 24.66 |
| MitraClip System | Average Dosages of GDMT | ARN Inhibitors | 11.03 mg | Standard Deviation 7.25 |
| MitraClip System | Average Dosages of GDMT | ACE Inhibitors | 12.23 mg | Standard Deviation 13.29 |
| Control Group | Average Dosages of GDMT | ARN Inhibitors | 9.68 mg | Standard Deviation 5.89 |
| Control Group | Average Dosages of GDMT | ACE Inhibitors | 12.28 mg | Standard Deviation 12.87 |
| Control Group | Average Dosages of GDMT | ARBs | 11.13 mg | Standard Deviation 7.87 |
| Control Group | Average Dosages of GDMT | Aldosterone Antagonists | 28.97 mg | Standard Deviation 31.5 |
| Control Group | Average Dosages of GDMT | Beta Blockers | 27.83 mg | Standard Deviation 23.79 |
| Control Group | Average Dosages of GDMT | Vasodilators (Nitrate) | 44.53 mg | Standard Deviation 32.5 |
| Control Group | Average Dosages of GDMT | Vasodilators (Hydralazine) | 101.92 mg | Standard Deviation 86.3 |
Other Pre-specified
Average Dosages of Guideline Directed Medical Therapy (GDMT)
Time frame: Baseline
Population: All available data has been reported and includes subjects on the drugs mentioned below. Not all subjects were on all the drugs.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MitraClip System | Average Dosages of Guideline Directed Medical Therapy (GDMT) | Aldosterone Antagonists | 24.51 mg | Standard Deviation 11.62 |
| MitraClip System | Average Dosages of Guideline Directed Medical Therapy (GDMT) | Vasodilators (Nitrate) | 59.61 mg | Standard Deviation 43.81 |
| MitraClip System | Average Dosages of Guideline Directed Medical Therapy (GDMT) | Angiotensin-Receptor Blockers (ARB) | 14.21 mg | Standard Deviation 9.37 |
| MitraClip System | Average Dosages of Guideline Directed Medical Therapy (GDMT) | Vasodilators (Hydralazine) | 139.85 mg | Standard Deviation 108.46 |
| MitraClip System | Average Dosages of Guideline Directed Medical Therapy (GDMT) | Beta Blockers | 31.91 mg | Standard Deviation 24.9 |
| MitraClip System | Average Dosages of Guideline Directed Medical Therapy (GDMT) | ARN Inhibitors | 12.64 mg | Standard Deviation 9.31 |
| MitraClip System | Average Dosages of Guideline Directed Medical Therapy (GDMT) | ACE Inhibitors | 14.18 mg | Standard Deviation 15.19 |
| Control Group | Average Dosages of Guideline Directed Medical Therapy (GDMT) | ARN Inhibitors | 9.65 mg | Standard Deviation 6.8 |
| Control Group | Average Dosages of Guideline Directed Medical Therapy (GDMT) | ACE Inhibitors | 13.44 mg | Standard Deviation 13.56 |
| Control Group | Average Dosages of Guideline Directed Medical Therapy (GDMT) | Angiotensin-Receptor Blockers (ARB) | 12.35 mg | Standard Deviation 8.69 |
| Control Group | Average Dosages of Guideline Directed Medical Therapy (GDMT) | Aldosterone Antagonists | 28.96 mg | Standard Deviation 34.12 |
| Control Group | Average Dosages of Guideline Directed Medical Therapy (GDMT) | Beta Blockers | 29.92 mg | Standard Deviation 25.79 |
| Control Group | Average Dosages of Guideline Directed Medical Therapy (GDMT) | Vasodilators (Nitrate) | 42.80 mg | Standard Deviation 26.97 |
| Control Group | Average Dosages of Guideline Directed Medical Therapy (GDMT) | Vasodilators (Hydralazine) | 109.27 mg | Standard Deviation 86.45 |
Other Pre-specified
BNP or NT-proBNP Levels
Time frame: 12 months
Population: All available data has been reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MitraClip System | BNP or NT-proBNP Levels | BNP | 621.45 pg/ml | Standard Deviation 606.99 |
| MitraClip System | BNP or NT-proBNP Levels | NT-proBNP | 3362.49 pg/ml | Standard Deviation 4332.12 |
| Control Group | BNP or NT-proBNP Levels | BNP | 808.26 pg/ml | Standard Deviation 1711.71 |
| Control Group | BNP or NT-proBNP Levels | NT-proBNP | 3977.80 pg/ml | Standard Deviation 5689.7 |
Other Pre-specified
BNP or NT-proBNP Levels
Time frame: 30 days
Population: All available data has been reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MitraClip System | BNP or NT-proBNP Levels | BNP | 875.91 pg/ml | Standard Deviation 931.18 |
| MitraClip System | BNP or NT-proBNP Levels | NT-proBNP | 4907.58 pg/ml | Standard Deviation 7483.72 |
| Control Group | BNP or NT-proBNP Levels | BNP | 1065.55 pg/ml | Standard Deviation 1206.34 |
| Control Group | BNP or NT-proBNP Levels | NT-proBNP | 5244.16 pg/ml | Standard Deviation 7851.05 |
Other Pre-specified
Brain Natriuretic Peptide (BNP) or N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels)
Time frame: Baseline
Population: All available data has been reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MitraClip System | Brain Natriuretic Peptide (BNP) or N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels) | BNP | 1014.77 pg/ml | Standard Deviation 1085.98 |
| MitraClip System | Brain Natriuretic Peptide (BNP) or N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels) | NT-proBNP | 5174.33 pg/ml | Standard Deviation 6566.61 |
| Control Group | Brain Natriuretic Peptide (BNP) or N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels) | BNP | 1017.13 pg/ml | Standard Deviation 1212.77 |
| Control Group | Brain Natriuretic Peptide (BNP) or N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP Levels) | NT-proBNP | 5943.86 pg/ml | Standard Deviation 8437.61 |
Other Pre-specified
Cardiac Output
The amount of blood the heart pumps through the circulatory system in a minute.
Time frame: 24 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Cardiac Output | 3.41 Liters/minute | Standard Deviation 0.96 |
| Control Group | Cardiac Output | 3.38 Liters/minute | Standard Deviation 1.01 |
Other Pre-specified
Cardiac Output
The amount of blood the heart pumps through the circulatory system in a minute.
Time frame: 5 years
Population: All available electrocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Cardiac Output | 3.43 liters/minute | Standard Deviation 1.02 |
| Control Group | Cardiac Output | 3.41 liters/minute | Standard Deviation 1.1 |
Other Pre-specified
Cardiac Output
The amount of blood the heart pumps through the circulatory system in a minute.
Time frame: 4 years
Population: All available electrocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Cardiac Output | 3.49 liters/minute | Standard Deviation 0.99 |
| Control Group | Cardiac Output | 3.42 liters/minute | Standard Deviation 1.27 |
Other Pre-specified
Cardiac Output
The amount of blood the heart pumps through the circulatory system in a minute.
Time frame: 3 years
Population: All available data has been entered.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Cardiac Output | 3.39 L/min | Standard Deviation 1.01 |
| Control Group | Cardiac Output | 3.36 L/min | Standard Deviation 1.08 |
Other Pre-specified
Cardiac Output
The amount of blood the heart pumps through the circulatory system in a minute.
Time frame: 12 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Cardiac Output | 3.59 Liters/minute | Standard Deviation 1.07 |
| Control Group | Cardiac Output | 3.66 Liters/minute | Standard Deviation 1.2 |
Other Pre-specified
Cardiac Output
The amount of blood the heart pumps through the circulatory system in a minute.
Time frame: 6 months
Population: All available echocardiogram has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Cardiac Output | 3.53 Liters/minute | Standard Deviation 1.06 |
| Control Group | Cardiac Output | 3.53 Liters/minute | Standard Deviation 1.16 |
Other Pre-specified
Cardiac Output
The amount of blood the heart pumps through the circulatory system in a minute.
Time frame: At discharge (or 30 days if discharge echocardiogram is not available)
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Cardiac Output | 3.79 Liters/minute | Standard Deviation 1.17 |
| Control Group | Cardiac Output | 3.61 Liters/minute | Standard Deviation 1.18 |
Other Pre-specified
Cardiac Output
The amount of blood the heart pumps through the circulatory system in a minute.
Time frame: Baseline
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Cardiac Output | 3.61 Liters/minute | Standard Deviation 1.09 |
| Control Group | Cardiac Output | 3.49 Liters/minute | Standard Deviation 1.08 |
Other Pre-specified
Cardiopulmonary Exercise (CPX) Testing
A substudy endpoint will utilize peak oxygen consumption oxygen uptake (VO2) as a parameter for cardiopulmonary exercise testing on a total of at least 50 and up to 100 subjects. The CPX analysis variables are: * Peak VO2 (ml/kg/min) - CPX Sub-study endpoint, descriptive analysis only, not powered for statistical significance * Exercise duration (min) * Peak workload (watts) * Maximum heart rate during exercise (beats/min) * Peak VE (l/min) * Respiratory Exchange Ratio (RER, VCO2/VO2) * VE/VCO2 slope * Ventilatory Threshold (ml/kg/min) * Borg scale * Exercise termination reason * Type of exercise (treadmill vs cycling)
Time frame: Baseline
Population: A total of 14 subjects were enrolled in the CPA sub study. However CPX data was available for only 2 subjects in the device group and 1 subject in the control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Cardiopulmonary Exercise (CPX) Testing | 12.85 ml/kg/min | Standard Deviation 0.78 |
| Control Group | Cardiopulmonary Exercise (CPX) Testing | 6.00 ml/kg/min | — |
Other Pre-specified
Cardiopulmonary Exercise (CPX) Testing
A substudy endpoint will utilize peak oxygen consumption oxygen uptake (VO2) as a parameter for cardiopulmonary exercise testing on a total of at least 50 and up to 100 subjects. The CPX analysis variables are: * Peak VO2 (ml/kg/min) - CPX Sub-study endpoint, descriptive analysis only, not powered for statistical significance * Exercise duration (min) * Peak workload (watts) * Maximum heart rate during exercise (beats/min) * Peak VE (l/min) * Respiratory Exchange Ratio (RER, VCO2/VO2) * VE/VCO2 slope * Ventilatory Threshold (ml/kg/min) * Borg scale * Exercise termination reason * Type of exercise (treadmill vs cycling)
Time frame: 12 months
Population: A total of 14 subjects participated in the CPX sub-study. CPX test data was available in 2 subjects in the device group and 1 subject in the control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Cardiopulmonary Exercise (CPX) Testing | 14.50 ml/kg/min | Standard Deviation 6.36 |
| Control Group | Cardiopulmonary Exercise (CPX) Testing | 6.80 ml/kg/min | — |
Other Pre-specified
Cardiopulmonary Exercise (CPX) Testing: Mean Changes in Peak VO2
Mean changes in peak VO2 (ml/kg/min) will be summarized at 12 months from baseline for the subset of patients who complete a CPX test at baseline and 12 months. A comparison of change from baseline between Device and Control groups will be presented. The CPX analysis variables are: * Peak VO2 (ml/kg/min) - CPX Sub-study endpoint, descriptive analysis only, not powered for statistical significance * Exercise duration (min) * Peak workload (watts) * Maximum heart rate during exercise (beats/min) * Peak VE (l/min) * Respiratory Exchange Ratio (RER, VCO2/VO2) * VE/VCO2 slope * Ventilatory Threshold (ml/kg/min) * Borg scale * Exercise termination reason * Type of exercise (treadmill vs cycling)
Time frame: Between baseline and 12 months
Population: A total of 14 subjects participated in the CPX sub-study. CPX test data was available in 2 subjects in the device group and 1 subject in the control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Cardiopulmonary Exercise (CPX) Testing: Mean Changes in Peak VO2 | 1.65 ml/kg/min | Standard Deviation 5.59 |
| Control Group | Cardiopulmonary Exercise (CPX) Testing: Mean Changes in Peak VO2 | 0.80 ml/kg/min | — |
Other Pre-specified
Change in 6MWD From Baseline
Time frame: Between baseline and 30 days
Population: All available data has been reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Change in 6MWD From Baseline | 31.6 meters | Standard Deviation 106.4 |
| Control Group | Change in 6MWD From Baseline | -0.9 meters | Standard Deviation 83.5 |
Other Pre-specified
Change in 6MWD From Baseline
Time frame: Between baseline and 24 months
Population: All available data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Change in 6MWD From Baseline | 12.5 meters | Standard Deviation 103 |
| Control Group | Change in 6MWD From Baseline | 1.1 meters | Standard Deviation 133.6 |
Other Pre-specified
Change in 6MWD From Baseline
Time frame: Between baseline and 12 months
Population: All available data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Change in 6MWD From Baseline | 33.9 meters | Standard Deviation 99.6 |
| Control Group | Change in 6MWD From Baseline | 5.5 meters | Standard Deviation 115 |
Other Pre-specified
Change in 6MWD From Baseline
Time frame: Between baseline and 6 months
Population: All available data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Change in 6MWD From Baseline | 25.9 meters | Standard Deviation 100.6 |
| Control Group | Change in 6MWD From Baseline | 0.66 meters | Standard Deviation 99.9 |
Other Pre-specified
Change in KCCQ QoL Scores From Baseline
Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 12 months KCCQ score. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time frame: Between baseline and 12 months
Population: All available paired data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Change in KCCQ QoL Scores From Baseline | 17.0 KCCQ score on a points scale | Standard Deviation 25.4 |
| Control Group | Change in KCCQ QoL Scores From Baseline | 5.1 KCCQ score on a points scale | Standard Deviation 24.5 |
Other Pre-specified
Change in KCCQ QoL Scores From Baseline
Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 30 days KCCQ score. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time frame: Between baseline and 30 days
Population: All available paired data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Change in KCCQ QoL Scores From Baseline | 16.9 KCCQ score on a points scale | Standard Deviation 22.8 |
| Control Group | Change in KCCQ QoL Scores From Baseline | 2.1 KCCQ score on a points scale | Standard Deviation 18.6 |
Other Pre-specified
Change in KCCQ QoL Scores From Baseline
Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 6 months KCCQ score. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time frame: Between baseline and 6 months
Population: All available paired data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Change in KCCQ QoL Scores From Baseline | 18.5 KCCQ score on a points scale | Standard Deviation 24.9 |
| Control Group | Change in KCCQ QoL Scores From Baseline | 5.3 KCCQ score on a points scale | Standard Deviation 23 |
Other Pre-specified
Change in KCCQ QoL Scores From Baseline
Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 24 months KCCQ score. The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time frame: Between baseline and 24 months
Population: All available paired data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Change in KCCQ QoL Scores From Baseline | 17.4 KCCQ score on a points scale | Standard Deviation 25.8 |
| Control Group | Change in KCCQ QoL Scores From Baseline | 3.4 KCCQ score on a points scale | Standard Deviation 26.5 |
Other Pre-specified
Change in SF-36 QoL Scores From Baseline
Paired data looking at difference between the baseline SF-36 and 6 months days SF-36. The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
Time frame: Between baseline and 6 months
Population: All available data has been reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MitraClip System | Change in SF-36 QoL Scores From Baseline | SF-36 PCS | 5.5 SF-36 score on a points scale | Standard Deviation 10.2 |
| MitraClip System | Change in SF-36 QoL Scores From Baseline | SF-36 MCS | 4.6 SF-36 score on a points scale | Standard Deviation 12.2 |
| Control Group | Change in SF-36 QoL Scores From Baseline | SF-36 PCS | 1.0 SF-36 score on a points scale | Standard Deviation 8.7 |
| Control Group | Change in SF-36 QoL Scores From Baseline | SF-36 MCS | 1.1 SF-36 score on a points scale | Standard Deviation 10.7 |
Other Pre-specified
Change in SF-36 QoL Scores From Baseline
Paired data looking at difference between the baseline SF-36 and 24 months SF-36. The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
Time frame: Between baseline and 24 months
Population: All available data has been reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MitraClip System | Change in SF-36 QoL Scores From Baseline | SF-36 PCS | 5.0 SF-36 score on a points scale | Standard Deviation 10.4 |
| MitraClip System | Change in SF-36 QoL Scores From Baseline | SF-36 MCS | 3.8 SF-36 score on a points scale | Standard Deviation 14.2 |
| Control Group | Change in SF-36 QoL Scores From Baseline | SF-36 PCS | 0.7 SF-36 score on a points scale | Standard Deviation 10.6 |
| Control Group | Change in SF-36 QoL Scores From Baseline | SF-36 MCS | -0.3 SF-36 score on a points scale | Standard Deviation 12.9 |
Other Pre-specified
Change in SF-36 QoL Scores From Baseline
Paired data looking at difference between the baseline SF-36 and 30 days SF-36. The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
Time frame: Between baseline and 30 days
Population: All available data has been reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MitraClip System | Change in SF-36 QoL Scores From Baseline | SF-36 PCS | 6.0 SF-36 score on a points scale | Standard Deviation 8.9 |
| MitraClip System | Change in SF-36 QoL Scores From Baseline | SF_36 MCS | 4.2 SF-36 score on a points scale | Standard Deviation 12.2 |
| Control Group | Change in SF-36 QoL Scores From Baseline | SF_36 MCS | 0.4 SF-36 score on a points scale | Standard Deviation 12 |
| Control Group | Change in SF-36 QoL Scores From Baseline | SF-36 PCS | 0.6 SF-36 score on a points scale | Standard Deviation 8.1 |
Other Pre-specified
Change in SF-36 QoL Scores From Baseline
Paired data looking at difference between the baseline SF-36 and 12 month SF-36. The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
Time frame: Between baseline and 12 months
Population: All available data has been reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MitraClip System | Change in SF-36 QoL Scores From Baseline | SF-36 PCS | 5.0 SF-36 score on a points scale | Standard Deviation 10.4 |
| MitraClip System | Change in SF-36 QoL Scores From Baseline | SF-36 MCS | 4.3 SF-36 score on a points scale | Standard Deviation 13.2 |
| Control Group | Change in SF-36 QoL Scores From Baseline | SF-36 PCS | 0.8 SF-36 score on a points scale | Standard Deviation 9.8 |
| Control Group | Change in SF-36 QoL Scores From Baseline | SF-36 MCS | 1.9 SF-36 score on a points scale | Standard Deviation 13.4 |
Other Pre-specified
Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention
Time frame: 4 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention | 2 Participants |
| Control Group | Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention | 0 Participants |
Other Pre-specified
Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention
Time frame: 3 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention | 2 Participants |
| Control Group | Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention | 0 Participants |
Other Pre-specified
Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention | 2 Participants |
| Control Group | Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention | 0 Participants |
Other Pre-specified
Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention | 2 Participants |
| Control Group | Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention | 0 Participants |
Other Pre-specified
Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention | 2 Participants |
| Control Group | Clinically Significant Atrial Septal Defect (ASD) That Requires Intervention | 0 Participants |
Other Pre-specified
De Novo MitraClip Device Intervention in Control Group
Time frame: Through 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | De Novo MitraClip Device Intervention in Control Group | NA Participants |
| Control Group | De Novo MitraClip Device Intervention in Control Group | 67 Participants |
Other Pre-specified
Device or Procedure-Related Adverse Events
Device or procedure-related adverse events are defined as adverse events that are adjudicated by the Clinical Events Committee as possibly, probably or definitely device and/or procedure-related, regardless of the temporal relationship to the MitraClip procedure. Device or procedure-related adverse events will be broken down into those that occur within 30 days of the procedure and those that occur after 30 days of the procedure. Examples of device-related adverse events are: myocardial perforation, Single Leaflet Device Attachment, embolization of the MitraClip device or MitraClip System components, iatrogenic atrial septal defect, mitral valve stenosis, need for mitral valve replacement instead of repair due at least in part to the MitraClip procedure or the presence of the MitraClip device.
Time frame: Within and after 30 days of the procedure
Population: All available data has been reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Device or Procedure-Related Adverse Events | Occurred within 30 days | 17 Participants |
| MitraClip System | Device or Procedure-Related Adverse Events | Occurred between 31 days and 365 days | 4 Participants |
Other Pre-specified
Device Procedure Time
Defined as the time elapsed from the start of the transseptal procedure to the time the Steerable Guide Catheter is removed
Time frame: Day 0
Population: Device procedure time was not available for all implanted subjects. Data was available for 282 subjects from 302 randomized subjects in device arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Device Procedure Time | 118.9 minutes | Standard Deviation 63.5 |
Other Pre-specified
Device-related Complications in Device Group Subjects and Control Group Subjects Who Undergo the MitraClip Procedure
Time frame: Through 5 years
Other Pre-specified
Device Time
Defined as the time the Steerable Guide Catheter is placed in the intra-atrial septum until the time the MitraClip Delivery System (CDS) is retracted into the Steerable Guide Catheter
Time frame: Day 0
Population: Device time available for all 287 subjects implanted with MitraClip.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Device Time | 82.7 minutes | Standard Deviation 80.8 |
Other Pre-specified
Each Subscale for QoL (KCCQ)
difference in means between Device and Control groups for the Kansas City Cardiomyopathy Questionnaire (KCCQ) for the physical limitation and symptom stability scores.
Time frame: 12 months
Population: 219 subjects from device group and 189 subjects from control group analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Each Subscale for QoL (KCCQ) | 9.90 KCCQ score on a points scale |
Other Pre-specified
Each Subscale for QoL (KCCQ)
difference in means between Device and Control groups for the Kansas City Cardiomyopathy Questionnaire (KCCQ) for the physical limitation and symptom stability scores.
Time frame: 24 months
Population: 128 subjects in the device group and 90 subjects in the control group were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Each Subscale for QoL (KCCQ) | 8.01 KCCQ score on a points scale |
Other Pre-specified
Effective Regurgitant Orifice Area
Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time frame: Baseline
Population: Echocardiogram data was available for the 289 subjects in the device arm and 302 subjects in the control arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Effective Regurgitant Orifice Area | 0.41 cm^2 | Standard Deviation 0.15 |
| Control Group | Effective Regurgitant Orifice Area | 0.40 cm^2 | Standard Deviation 0.15 |
Other Pre-specified
Effective Regurgitant Orifice Area
Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time frame: 24 months
Population: Echocardiogram data was available for 18 subjects in the device arm and 25 subjects in the control arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Effective Regurgitant Orifice Area | 0.15 cm^2 | Standard Deviation 0.09 |
| Control Group | Effective Regurgitant Orifice Area | 0.25 cm^2 | Standard Deviation 0.12 |
Other Pre-specified
Effective Regurgitant Orifice Area
Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time frame: 6 months
Population: Echocardiogram data was available for 39 subjects in the device arm and 54 subjects in the control arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Effective Regurgitant Orifice Area | 0.22 cm^2 | Standard Deviation 0.19 |
| Control Group | Effective Regurgitant Orifice Area | 0.25 cm^2 | Standard Deviation 0.14 |
Other Pre-specified
Effective Regurgitant Orifice Area
Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time frame: At discharge (or 30 days if discharge echocardiogram is not available)
Population: Echocardiogram data was available for 75 subjects in the device arm and 73 subjects in the control arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Effective Regurgitant Orifice Area | 0.14 cm^2 | Standard Deviation 0.08 |
| Control Group | Effective Regurgitant Orifice Area | 0.23 cm^2 | Standard Deviation 0.16 |
Other Pre-specified
Effective Regurgitant Orifice Area
Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time frame: 12 months
Population: Echocardiogram data was available for 39 subjects in the device arm and 46 subjects in the control arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Effective Regurgitant Orifice Area | 0.18 cm^2 | Standard Deviation 0.12 |
| Control Group | Effective Regurgitant Orifice Area | 0.26 cm^2 | Standard Deviation 0.19 |
Other Pre-specified
Effective Regurgitant Orifice Area
Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time frame: 4 years
Population: Echocardiogram data was available for the 8 subjects in the device arm and 6 subjects in the control arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Effective Regurgitant Orifice Area | 0.14 cm^2 | Standard Deviation 0.05 |
| Control Group | Effective Regurgitant Orifice Area | 0.19 cm^2 | Standard Deviation 0.12 |
Other Pre-specified
Effective Regurgitant Orifice Area
Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time frame: 5 years
Population: Echocardiogram data was available for the 7 subjects in the device arm and 7 subjects in the control arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Effective Regurgitant Orifice Area | 0.15 cm^2 | Standard Deviation 0.05 |
| Control Group | Effective Regurgitant Orifice Area | 0.15 cm^2 | Standard Deviation 0.05 |
Other Pre-specified
Effective Regurgitant Orifice Area
Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time frame: 3 years
Population: Echocardiogram data was available for 16 subjects in the device arm and 13 subjects in the control arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Effective Regurgitant Orifice Area | 0.18 cm^2 | Standard Deviation 0.2 |
| Control Group | Effective Regurgitant Orifice Area | 0.18 cm^2 | Standard Deviation 0.1 |
Other Pre-specified
Fluoroscopy Duration
Defined as the duration of exposure to fluoroscopy during the MitraClip procedure
Time frame: Day 0
Population: Fluoroscopy duration for all available subjects with MitraClip device
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Fluoroscopy Duration | 33.9 minutes | Standard Deviation 23.2 |
Other Pre-specified
Forward Stroke Volume
Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.
Time frame: 3 years
Population: All available data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Forward Stroke Volume | 49.19 mL | Standard Deviation 15.83 |
| Control Group | Forward Stroke Volume | 49.42 mL | Standard Deviation 15.29 |
Other Pre-specified
Forward Stroke Volume
Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.
Time frame: 12 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Forward Stroke Volume | 52.33 mL | Standard Deviation 16.46 |
| Control Group | Forward Stroke Volume | 53.49 mL | Standard Deviation 17.73 |
Other Pre-specified
Forward Stroke Volume
Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.
Time frame: 24 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Forward Stroke Volume | 50.23 mL | Standard Deviation 16.02 |
| Control Group | Forward Stroke Volume | 49.22 mL | Standard Deviation 15.7 |
Other Pre-specified
Forward Stroke Volume
Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.
Time frame: Baseline
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Forward Stroke Volume | 50.47 mL | Standard Deviation 16.52 |
| Control Group | Forward Stroke Volume | 50.72 mL | Standard Deviation 16.91 |
Other Pre-specified
Forward Stroke Volume
Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.
Time frame: At discharge (or 30 days if discharge echocardiogram is not available)
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Forward Stroke Volume | 52.41 mL | Standard Deviation 17.06 |
| Control Group | Forward Stroke Volume | 50.75 mL | Standard Deviation 17.69 |
Other Pre-specified
Forward Stroke Volume
Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.
Time frame: 6 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Forward Stroke Volume | 52.13 mL | Standard Deviation 16.6 |
| Control Group | Forward Stroke Volume | 49.89 mL | Standard Deviation 16.8 |
Other Pre-specified
Forward Stroke Volume
Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.
Time frame: 5 years
Population: All available electrocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Forward Stroke Volume | 49.70 mL | Standard Deviation 18.41 |
| Control Group | Forward Stroke Volume | 47.63 mL | Standard Deviation 16.75 |
Other Pre-specified
Forward Stroke Volume
Stroke volume is the amount of blood ejected from the ventricle with each cardiac cycle. It can be readily calculated by subtracting the end-systolic volume from the end-diastolic volume.
Time frame: 4 years
Population: All available electrocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Forward Stroke Volume | 50.95 mL | Standard Deviation 16.46 |
| Control Group | Forward Stroke Volume | 48.32 mL | Standard Deviation 14.36 |
Other Pre-specified
Health Economic Data
Time frame: Through 5 years
Other Pre-specified
Implant Rate
Defined as the rate of successful delivery and deployment of the MitraClip device(s) with echocardiographic evidence of leaflet approximation and retrieval of the delivery catheter
Time frame: Day 0
Population: Subjects randomized to the device arm
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Implant Rate | 287 Participants |
Other Pre-specified
Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time frame: Baseline
Population: All available data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores | 53.2 KCCQ score on a points scale | Standard Deviation 22.8 |
| Control Group | Kansas City Cardiomyopathy Questionnaire (KCCQ) QoL Scores | 51.6 KCCQ score on a points scale | Standard Deviation 23.3 |
Other Pre-specified
Kaplan-Meier Freedom From All-cause Mortality
Kaplan-Meier survival rate for all cause mortality at 48 months
Time frame: 4 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From All-cause Mortality | 51.3 percentage |
| Control Group | Kaplan-Meier Freedom From All-cause Mortality | 37.3 percentage |
Other Pre-specified
Kaplan-Meier Freedom From All-cause Mortality
Kaplan-Meier survival rate for all cause mortality at 24 months
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From All-cause Mortality | 71.9 percentage |
| Control Group | Kaplan-Meier Freedom From All-cause Mortality | 57.3 percentage |
Other Pre-specified
Kaplan-Meier Freedom From All-cause Mortality
Kaplan-Meier survival rate for all cause mortality at 36 months
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From All-cause Mortality | 59.7 Percentage |
| Control Group | Kaplan-Meier Freedom From All-cause Mortality | 45.9 Percentage |
Other Pre-specified
Kaplan-Meier Freedom From All-cause Mortality
Kaplan-Meier survival rate for all cause mortality at 60 months
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From All-cause Mortality | 42.7 percentage |
| Control Group | Kaplan-Meier Freedom From All-cause Mortality | 32.8 percentage |
Other Pre-specified
Kaplan-Meier Freedom From Cardiovascular Mortality
Kaplan-Meier survival rate for Cardiovascular mortality.
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From Cardiovascular Mortality | 77.6 percentage |
| Control Group | Kaplan-Meier Freedom From Cardiovascular Mortality | 64.5 percentage |
Other Pre-specified
Kaplan-Meier Freedom From Cardiovascular Mortality
Kaplan-Meier survival rate for Cardiovascular mortality.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From Cardiovascular Mortality | 86.2 percentage |
| Control Group | Kaplan-Meier Freedom From Cardiovascular Mortality | 80.7 percentage |
Other Pre-specified
Kaplan-Meier Freedom From Cardiovascular Mortality
Kaplan-Meier survival rate for Cardiovascular mortality.
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From Cardiovascular Mortality | 66.7 Percentage |
| Control Group | Kaplan-Meier Freedom From Cardiovascular Mortality | 54.6 Percentage |
Other Pre-specified
Kaplan-Meier Freedom From Cardiovascular Mortality
Time frame: 4 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From Cardiovascular Mortality | 58.8 percentage |
| Control Group | Kaplan-Meier Freedom From Cardiovascular Mortality | 47.0 percentage |
Other Pre-specified
Kaplan-Meier Freedom From Cardiovascular Mortality
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From Cardiovascular Mortality | 51.2 percentage |
| Control Group | Kaplan-Meier Freedom From Cardiovascular Mortality | 42.8 percentage |
Other Pre-specified
Kaplan-Meier Freedom From the Components of the Primary Safety Composite
Freedom from the components of the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety.
Time frame: 3 years in Device group
Population: All available subjects within the 36 month (1096 days) window.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Heart Transplant | 96.6 Percentage |
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Single Leaflet DeviceAttachment (SLDA) | 99.3 Percentage |
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Embolization | 99.7 Percentage |
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Left Ventricular AssistDevice (LVAD) | 94.9 Percentage |
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Non-electivecardiovascular surgery | 99.7 Percentage |
Other Pre-specified
Kaplan-Meier Freedom From the Components of the Primary Safety Composite
Freedom from the components of the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety.
Time frame: 12 months in Device group
Population: All eligible subjects with MitraClip until the 365 day window.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Heart Transplant | 99.2 percentage |
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Non-elective Cardiovascular surgery | 99.7 percentage |
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Single Leaflet Device Attachment (SLDA) | 99.3 percentage |
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Embolization | 99.7 percentage |
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Left Ventricular Assist Device (LVAD) | 98.8 percentage |
Other Pre-specified
Kaplan-Meier Freedom From the Components of the Primary Safety Composite
Freedom from the components of the primary safety composite of device relatedcomplications including Single Leaflet Device Attachment (SLDA), deviceembolizations, endocarditis requiring surgery, Echocardiography Core Laboratoryconfirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at12 months will be the primary measure of safety.
Time frame: 4 years in Device group
Population: All subjects within the 4 year (1461 days) window.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Left Ventricular Assist Device (LVAD) | 94.2 percentage |
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Single Leaflet Device Attachment (SLDA) | 99.3 percentage |
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Embolization | 99.7 percentage |
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Heart Transplant | 95.3 percentage |
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Non-elective Cardiovascular Surgery | 99.7 percentage |
Other Pre-specified
Kaplan-Meier Freedom From the Components of the Primary Safety Composite
Freedom from the components of the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety.
Time frame: 24 months in Device group
Population: All available subjects with data within the 2 year (731 days) window
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Single Leaflet Device Attachment (SLDA) | 99.3 percentage |
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Embolization | 99.7 percentage |
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Left Ventricular Assist Device (LVAD) | 97.4 percentage |
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Heart Transplant | 98.7 percentage |
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Non-elective cardiovascular surgery | 99.7 percentage |
Other Pre-specified
Kaplan-Meier Freedom From the Components of the Primary Safety Composite
Freedom from the components of the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at12 months will be the primary measure of safety.
Time frame: 5 years in Device group
Population: All available subjects within 5 year (1826 days) window.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Embolization | 99.7 percentage |
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Left VentricularAssistDevice (LVAD) | 93.5 percentage |
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Single LeafletDeviceAttachment(SLDA) | 99.3 percentage |
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Heart Transplant | 95.3 percentage |
| MitraClip System | Kaplan-Meier Freedom From the Components of the Primary Safety Composite | Non-electivecardiovascularsurgery | 99.7 percentage |
Other Pre-specified
Kaplan-Meier Freedom From the First Cardiovascular Hospitalization
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the First Cardiovascular Hospitalization | 61.7 Percentage |
| Control Group | Kaplan-Meier Freedom From the First Cardiovascular Hospitalization | 51.3 Percentage |
Other Pre-specified
Kaplan-Meier Freedom From the First Cardiovascular Hospitalization
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the First Cardiovascular Hospitalization | 49.5 Percentage |
| Control Group | Kaplan-Meier Freedom From the First Cardiovascular Hospitalization | 33.5 Percentage |
Other Pre-specified
Kaplan-Meier Freedom From the First Cardiovascular Hospitalization
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the First Cardiovascular Hospitalization | 23.0 Percentage |
| Control Group | Kaplan-Meier Freedom From the First Cardiovascular Hospitalization | 10.8 Percentage |
Other Pre-specified
Kaplan-Meier Freedom From the First Cardiovascular Hospitalization
Time frame: 4 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the First Cardiovascular Hospitalization | 28.5 Percentage |
| Control Group | Kaplan-Meier Freedom From the First Cardiovascular Hospitalization | 14.8 Percentage |
Other Pre-specified
Kaplan-Meier Freedom From the First Cardiovascular Hospitalization
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the First Cardiovascular Hospitalization | 37.3 Percentage |
| Control Group | Kaplan-Meier Freedom From the First Cardiovascular Hospitalization | 17.5 Percentage |
Other Pre-specified
Kaplan-Meier Freedom From the First HF Related Hospitalization
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the First HF Related Hospitalization | 39.0 percentage |
| Control Group | Kaplan-Meier Freedom From the First HF Related Hospitalization | 17.0 percentage |
Other Pre-specified
Kaplan-Meier Freedom From the First HF Related Hospitalization
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the First HF Related Hospitalization | 64.5 Percentage |
| Control Group | Kaplan-Meier Freedom From the First HF Related Hospitalization | 43.9 Percentage |
Other Pre-specified
Kaplan-Meier Freedom From the First HF Related Hospitalization
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the First HF Related Hospitalization | 53.2 Percentage |
| Control Group | Kaplan-Meier Freedom From the First HF Related Hospitalization | 23.6 Percentage |
Other Pre-specified
Kaplan-Meier Freedom From the First HF Related Hospitalization
Time frame: 4 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the First HF Related Hospitalization | 45.7 percentage |
| Control Group | Kaplan-Meier Freedom From the First HF Related Hospitalization | 22.3 percentage |
Other Pre-specified
Kaplan-Meier Freedom From the First HF Related Hospitalization
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the First HF Related Hospitalization | 74.4 Percentage |
| Control Group | Kaplan-Meier Freedom From the First HF Related Hospitalization | 60.4 Percentage |
Other Pre-specified
Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality | 66.5 Percentage |
| Control Group | Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality | 53.8 Percentage |
Other Pre-specified
Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality
Survival rate from the first HF related hospitalization or all-cause mortality.
Time frame: 24 months
Population: All available data has been reported.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality | 54.8 percentage |
| Control Group | Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality | 33.8 percentage |
Other Pre-specified
Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality | 41.5 Percentage |
| Control Group | Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality | 15.5 Percentage |
Other Pre-specified
Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality
Time frame: 4 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality | 34.0 percentage |
| Control Group | Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality | 12.8 percentage |
Other Pre-specified
Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality | 26.4 percentage |
| Control Group | Kaplan-Meier Freedom From the First HF Related Hospitalization or All-cause Mortality | 8.5 percentage |
Other Pre-specified
Kaplan-Meier Freedom From the Primary Safety Composite
Freedom from the primary safety composite of device related complications including Single Leaflet DeviceAttachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratoryconfirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complicationsrequiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety.
Time frame: 3 years in Device group
Population: All available subjects with data within the 36 months (1096 days) window.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the Primary Safety Composite | 91.2 Percentage |
Other Pre-specified
Kaplan-Meier Freedom From the Primary Safety Composite
Freedom from the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety.
Time frame: 24 months in Device group
Population: All available subjects with data within the 24 months (731 days) window.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the Primary Safety Composite | 94.8 percentage |
Other Pre-specified
Kaplan-Meier Freedom From the Primary Safety Composite
Freedom from the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety.
Time frame: 4 years in Device group
Population: All available echocardiogram data has been presented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the Primary Safety Composite | 89.9 percentage |
Other Pre-specified
Kaplan-Meier Freedom From the Primary Safety Composite
Freedom from the primary safety composite of device related complications including Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, or any device related complications requiring non-elective cardiovascular surgery at 12 months will be the primary measure of safety.
Time frame: 5 years in Device group
Population: All available electrocardiogram has been presented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MitraClip System | Kaplan-Meier Freedom From the Primary Safety Composite | 89.2 percentage |
Other Pre-specified
KCCQ QoL Scores
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time frame: 6 months
Population: All available data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | KCCQ QoL Scores | 73.0 KCCQ score on a points scale | Standard Deviation 21.3 |
| Control Group | KCCQ QoL Scores | 59.0 KCCQ score on a points scale | Standard Deviation 24.7 |
Other Pre-specified
KCCQ QoL Scores
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time frame: 30 days
Population: All available data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | KCCQ QoL Scores | 70.9 KCCQ score on a points scale | Standard Deviation 21.1 |
| Control Group | KCCQ QoL Scores | 54.6 KCCQ score on a points scale | Standard Deviation 24.7 |
Other Pre-specified
KCCQ QoL Scores
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time frame: 24 months
Population: All available data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | KCCQ QoL Scores | 71.3 KCCQ score on a points scale | Standard Deviation 23.3 |
| Control Group | KCCQ QoL Scores | 58.9 KCCQ score on a points scale | Standard Deviation 25.2 |
Other Pre-specified
KCCQ QoL Scores
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time frame: 12 months
Population: All available data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | KCCQ QoL Scores | 71.8 KCCQ score on a points scale | Standard Deviation 22.2 |
| Control Group | KCCQ QoL Scores | 60.2 KCCQ score on a points scale | Standard Deviation 24.5 |
Other Pre-specified
Left Ventricle End Diastolic Volume (LVEDV)
Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.
Time frame: 24 months
Population: All available echocardiogram data has been presented
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricle End Diastolic Volume (LVEDV) | 174.5 mL | Standard Deviation 60.9 |
| Control Group | Left Ventricle End Diastolic Volume (LVEDV) | 184.6 mL | Standard Deviation 73.5 |
Other Pre-specified
Left Ventricle End Diastolic Volume (LVEDV)
Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.
Time frame: 12 months
Population: All available echocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricle End Diastolic Volume (LVEDV) | 179.4 mL | Standard Deviation 66.2 |
| Control Group | Left Ventricle End Diastolic Volume (LVEDV) | 176.3 mL | Standard Deviation 65.1 |
Other Pre-specified
Left Ventricle End Diastolic Volume (LVEDV)
Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.
Time frame: 6 months
Population: All available echocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricle End Diastolic Volume (LVEDV) | 181.4 mL | Standard Deviation 65.1 |
| Control Group | Left Ventricle End Diastolic Volume (LVEDV) | 182.6 mL | Standard Deviation 72.4 |
Other Pre-specified
Left Ventricle End Diastolic Volume (LVEDV)
Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.
Time frame: Baseline
Population: All available echocardiogram data used for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricle End Diastolic Volume (LVEDV) | 194.4 mL | Standard Deviation 69.2 |
| Control Group | Left Ventricle End Diastolic Volume (LVEDV) | 191.0 mL | Standard Deviation 72.9 |
Other Pre-specified
Left Ventricle End Diastolic Volume (LVEDV)
Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.
Time frame: At discharge (or 30 days if discharge echocardiogram is not available)
Population: All available echocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricle End Diastolic Volume (LVEDV) | 176.0 mL | Standard Deviation 64.6 |
| Control Group | Left Ventricle End Diastolic Volume (LVEDV) | 179.1 mL | Standard Deviation 68.4 |
Other Pre-specified
Left Ventricle End Diastolic Volume (LVEDV)
Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.
Time frame: 5 years
Population: All available echocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricle End Diastolic Volume (LVEDV) | 174.0 ml | Standard Deviation 67.1 |
| Control Group | Left Ventricle End Diastolic Volume (LVEDV) | 166.6 ml | Standard Deviation 77 |
Other Pre-specified
Left Ventricle End Diastolic Volume (LVEDV)
Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.
Time frame: 4 years
Population: All available electrocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricle End Diastolic Volume (LVEDV) | 166.0 mL | Standard Deviation 58.4 |
| Control Group | Left Ventricle End Diastolic Volume (LVEDV) | 161.6 mL | Standard Deviation 64.7 |
Other Pre-specified
Left Ventricle End Diastolic Volume (LVEDV)
Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.
Time frame: 3 years
Population: All available echocardiogram data has been presented
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricle End Diastolic Volume (LVEDV) | 169.6 mL | Standard Deviation 60.5 |
| Control Group | Left Ventricle End Diastolic Volume (LVEDV) | 172.2 mL | Standard Deviation 67.1 |
Other Pre-specified
Left Ventricular Ejection Fraction (LVEF)
Time frame: 4 years
Population: All available electrocardiogram has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular Ejection Fraction (LVEF) | 30.87 percentage | Standard Deviation 11.37 |
| Control Group | Left Ventricular Ejection Fraction (LVEF) | 33.39 percentage | Standard Deviation 13.09 |
Other Pre-specified
Left Ventricular Ejection Fraction (LVEF)
Time frame: 5 years
Population: All electrocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular Ejection Fraction (LVEF) | 28.73 percentage | Standard Deviation 11.26 |
| Control Group | Left Ventricular Ejection Fraction (LVEF) | 32.22 percentage | Standard Deviation 13.95 |
Other Pre-specified
Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular Ejection Fraction (LVEF) | 31.32 percentage | Standard Deviation 9.07 |
| Control Group | Left Ventricular Ejection Fraction (LVEF) | 31.30 percentage | Standard Deviation 9.58 |
Other Pre-specified
Left Ventricular Ejection Fraction (LVEF)
Time frame: At discharge (or 30 days if discharge echocardiogram is not available)
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular Ejection Fraction (LVEF) | 27.88 percentage | Standard Deviation 8.84 |
| Control Group | Left Ventricular Ejection Fraction (LVEF) | 31.11 percentage | Standard Deviation 10.45 |
Other Pre-specified
Left Ventricular Ejection Fraction (LVEF)
Time frame: 6 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular Ejection Fraction (LVEF) | 28.38 percentage | Standard Deviation 10.45 |
| Control Group | Left Ventricular Ejection Fraction (LVEF) | 30.44 percentage | Standard Deviation 10.15 |
Other Pre-specified
Left Ventricular Ejection Fraction (LVEF)
Time frame: 12 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular Ejection Fraction (LVEF) | 27.74 percentage | Standard Deviation 11.31 |
| Control Group | Left Ventricular Ejection Fraction (LVEF) | 29.72 percentage | Standard Deviation 10.06 |
Other Pre-specified
Left Ventricular Ejection Fraction (LVEF)
Time frame: 24 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular Ejection Fraction (LVEF) | 27.95 percentage | Standard Deviation 9.2 |
| Control Group | Left Ventricular Ejection Fraction (LVEF) | 30.68 percentage | Standard Deviation 12.38 |
Other Pre-specified
Left Ventricular Ejection Fraction (LVEF)
Time frame: 3 years
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular Ejection Fraction (LVEF) | 29.28 percentage | Standard Deviation 12.41 |
| Control Group | Left Ventricular Ejection Fraction (LVEF) | 31.67 percentage | Standard Deviation 12.76 |
Other Pre-specified
Left Ventricular End Diastolic Dimension (LVEDD)
Time frame: 5 years
Population: All available echocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Diastolic Dimension (LVEDD) | 6.09 cm | Standard Deviation 0.9 |
| Control Group | Left Ventricular End Diastolic Dimension (LVEDD) | 5.97 cm | Standard Deviation 0.91 |
Other Pre-specified
Left Ventricular End Diastolic Dimension (LVEDD)
Time frame: 3 years
Population: All Available echocardiogram data has been entered
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Diastolic Dimension (LVEDD) | 6.12 cm | Standard Deviation 0.78 |
| Control Group | Left Ventricular End Diastolic Dimension (LVEDD) | 6.11 cm | Standard Deviation 0.97 |
Other Pre-specified
Left Ventricular End Diastolic Dimension (LVEDD)
Time frame: 24 months
Population: All available echocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Diastolic Dimension (LVEDD) | 6.07 cm | Standard Deviation 0.92 |
| Control Group | Left Ventricular End Diastolic Dimension (LVEDD) | 6.18 cm | Standard Deviation 0.88 |
Other Pre-specified
Left Ventricular End Diastolic Dimension (LVEDD)
Time frame: 12 months
Population: All available echocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Diastolic Dimension (LVEDD) | 6.08 cm | Standard Deviation 0.77 |
| Control Group | Left Ventricular End Diastolic Dimension (LVEDD) | 6.10 cm | Standard Deviation 0.83 |
Other Pre-specified
Left Ventricular End Diastolic Dimension (LVEDD)
Time frame: 6 months
Population: All available echocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Diastolic Dimension (LVEDD) | 6.12 cm | Standard Deviation 0.77 |
| Control Group | Left Ventricular End Diastolic Dimension (LVEDD) | 6.15 cm | Standard Deviation 0.81 |
Other Pre-specified
Left Ventricular End Diastolic Dimension (LVEDD)
Time frame: At discharge (or 30 days if discharge echocardiogram is not available)
Population: All available echocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Diastolic Dimension (LVEDD) | 6.10 cm | Standard Deviation 0.75 |
| Control Group | Left Ventricular End Diastolic Dimension (LVEDD) | 7.41 cm | Standard Deviation 19.58 |
Other Pre-specified
Left Ventricular End Diastolic Dimension (LVEDD)
Time frame: 4 years
Population: All available echocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Diastolic Dimension (LVEDD) | 6.04 cm | Standard Deviation 0.81 |
| Control Group | Left Ventricular End Diastolic Dimension (LVEDD) | 6.07 cm | Standard Deviation 0.91 |
Other Pre-specified
Left Ventricular End Diastolic Dimension (LVEDD)
Time frame: Baseline
Population: All available echocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Diastolic Dimension (LVEDD) | 6.17 cm | Standard Deviation 0.73 |
| Control Group | Left Ventricular End Diastolic Dimension (LVEDD) | 6.19 cm | Standard Deviation 0.75 |
Other Pre-specified
Left Ventricular End Systolic Dimension (LVESD)
Time frame: 5 years
Population: All available electrocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Systolic Dimension (LVESD) | 5.31 cm | Standard Deviation 1.02 |
| Control Group | Left Ventricular End Systolic Dimension (LVESD) | 5.15 cm | Standard Deviation 1.02 |
Other Pre-specified
Left Ventricular End Systolic Dimension (LVESD)
Time frame: 24 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Systolic Dimension (LVESD) | 5.24 cm | Standard Deviation 1.07 |
| Control Group | Left Ventricular End Systolic Dimension (LVESD) | 5.26 cm | Standard Deviation 1.02 |
Other Pre-specified
Left Ventricular End Systolic Dimension (LVESD)
Time frame: 3 years
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Systolic Dimension (LVESD) | 5.30 cm | Standard Deviation 0.96 |
| Control Group | Left Ventricular End Systolic Dimension (LVESD) | 5.19 cm | Standard Deviation 1.16 |
Other Pre-specified
Left Ventricular End Systolic Dimension (LVESD)
Time frame: 4 years
Population: All available electrocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Systolic Dimension (LVESD) | 5.17 cm | Standard Deviation 0.95 |
| Control Group | Left Ventricular End Systolic Dimension (LVESD) | 5.01 cm | Standard Deviation 1.12 |
Other Pre-specified
Left Ventricular End Systolic Dimension (LVESD)
Time frame: Baseline
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Systolic Dimension (LVESD) | 5.28 cm | Standard Deviation 0.86 |
| Control Group | Left Ventricular End Systolic Dimension (LVESD) | 5.30 cm | Standard Deviation 0.89 |
Other Pre-specified
Left Ventricular End Systolic Dimension (LVESD)
Time frame: At discharge (or 30 days if discharge echocardiogram is not available)
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Systolic Dimension (LVESD) | 5.31 cm | Standard Deviation 0.89 |
| Control Group | Left Ventricular End Systolic Dimension (LVESD) | 6.12 cm | Standard Deviation 12.64 |
Other Pre-specified
Left Ventricular End Systolic Dimension (LVESD)
Time frame: 6 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Systolic Dimension (LVESD) | 5.34 cm | Standard Deviation 0.91 |
| Control Group | Left Ventricular End Systolic Dimension (LVESD) | 5.28 cm | Standard Deviation 0.96 |
Other Pre-specified
Left Ventricular End Systolic Dimension (LVESD)
Time frame: 12 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Systolic Dimension (LVESD) | 5.26 cm | Standard Deviation 0.95 |
| Control Group | Left Ventricular End Systolic Dimension (LVESD) | 5.25 cm | Standard Deviation 0.99 |
Other Pre-specified
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.
Time frame: 5 years
Population: All available electrocardiogram has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Systolic Volume (LVESV) | 129.0 ml | Standard Deviation 65.4 |
| Control Group | Left Ventricular End Systolic Volume (LVESV) | 119.3 ml | Standard Deviation 70.6 |
Other Pre-specified
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.
Time frame: 4 years
Population: All available electrocardiogram has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Systolic Volume (LVESV) | 118.7 ml | Standard Deviation 53.1 |
| Control Group | Left Ventricular End Systolic Volume (LVESV) | 112.7 ml | Standard Deviation 59.4 |
Other Pre-specified
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.
Time frame: Baseline
Population: All available echocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Systolic Volume (LVESV) | 135.5 mL | Standard Deviation 56.1 |
| Control Group | Left Ventricular End Systolic Volume (LVESV) | 134.3 mL | Standard Deviation 60.3 |
Other Pre-specified
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.
Time frame: At discharge (or 30 days if discharge echocardiogram is not available)
Population: All available echocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Systolic Volume (LVESV) | 129.3 mL | Standard Deviation 56.5 |
| Control Group | Left Ventricular End Systolic Volume (LVESV) | 125.7 mL | Standard Deviation 57.1 |
Other Pre-specified
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.
Time frame: 6 months
Population: All available echocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Systolic Volume (LVESV) | 133.1 mL | Standard Deviation 59.2 |
| Control Group | Left Ventricular End Systolic Volume (LVESV) | 129.1 mL | Standard Deviation 59.2 |
Other Pre-specified
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.
Time frame: 12 months
Population: All available echocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Systolic Volume (LVESV) | 133.0 mL | Standard Deviation 60.9 |
| Control Group | Left Ventricular End Systolic Volume (LVESV) | 125.9 mL | Standard Deviation 54.8 |
Other Pre-specified
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.
Time frame: 24 months
Population: All available echocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Systolic Volume (LVESV) | 127.4 mL | Standard Deviation 52.6 |
| Control Group | Left Ventricular End Systolic Volume (LVESV) | 132.2 mL | Standard Deviation 64.7 |
Other Pre-specified
Left Ventricular End Systolic Volume (LVESV)
Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction,or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at anypoint in the cardiac cycle.
Time frame: 3 years
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Left Ventricular End Systolic Volume (LVESV) | 124.3 mL | Standard Deviation 58.3 |
| Control Group | Left Ventricular End Systolic Volume (LVESV) | 122.9 mL | Standard Deviation 61.1 |
Other Pre-specified
Length of Index Hospitalization for MitraClip Procedure (Device Group)
Length of stay in the hospital for the MitraClip Index procedure (device group)
Time frame: Before MitraClip procedure on day 0
Population: Data was available for 293 subjects out of 302 subjects in the device group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Length of Index Hospitalization for MitraClip Procedure (Device Group) | 2.5 Days | Standard Deviation 2.3 |
Other Pre-specified
Major Bleeding
Major bleeding is defined as bleeding ≥ Type 3 based on a modified Bleeding Academic Research Consortium (BARC) definition
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Major Bleeding | 15 Participants |
| Control Group | Major Bleeding | 3 Participants |
Other Pre-specified
Mean Mitral Valve Gradient
The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, thevalve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valvegradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.
Time frame: 3 years
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Mean Mitral Valve Gradient | 3.45 mmHg | Standard Deviation 1.8 |
| Control Group | Mean Mitral Valve Gradient | 2.62 mmHg | Standard Deviation 1.99 |
Other Pre-specified
Mean Mitral Valve Gradient
The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.
Time frame: Baseline
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Mean Mitral Valve Gradient | 2.46 mmHg | Standard Deviation 1.05 |
| Control Group | Mean Mitral Valve Gradient | 2.28 mmHg | Standard Deviation 0.97 |
Other Pre-specified
Mean Mitral Valve Gradient
The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.
Time frame: At discharge (or 30 days if discharge echocardiogram is not available)
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Mean Mitral Valve Gradient | 4.10 mmHg | Standard Deviation 2.18 |
| Control Group | Mean Mitral Valve Gradient | 2.28 mmHg | Standard Deviation 1.28 |
Other Pre-specified
Mean Mitral Valve Gradient
The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.
Time frame: 6 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Mean Mitral Valve Gradient | 4.00 mmHg | Standard Deviation 1.98 |
| Control Group | Mean Mitral Valve Gradient | 2.28 mmHg | Standard Deviation 1.28 |
Other Pre-specified
Mean Mitral Valve Gradient
The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.
Time frame: 12 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Mean Mitral Valve Gradient | 3.88 mmHg | Standard Deviation 2.17 |
| Control Group | Mean Mitral Valve Gradient | 2.15 mmHg | Standard Deviation 1.3 |
Other Pre-specified
Mean Mitral Valve Gradient
The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.
Time frame: 24 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Mean Mitral Valve Gradient | 3.69 mmHg | Standard Deviation 1.76 |
| Control Group | Mean Mitral Valve Gradient | 2.25 mmHg | Standard Deviation 1.71 |
Other Pre-specified
Mean Mitral Valve Gradient
The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.
Time frame: 4 years
Population: All available electrocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Mean Mitral Valve Gradient | 3.69 mmHg | Standard Deviation 1.85 |
| Control Group | Mean Mitral Valve Gradient | 2.56 mmHg | Standard Deviation 1.41 |
Other Pre-specified
Mean Mitral Valve Gradient
The normal area of the mitral valve orifice is about 4-6 cm2 when the mitral valve area goes below 2 cm2, the valve causes an impediment to the flow of blood into the left ventricle, creating a pressure gradient (mitral valve gradient) across the mitral valve. This gradient may increase by the rise in heart rate or cardiac output.
Time frame: 5 years
Population: All available electrocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Mean Mitral Valve Gradient | 4.07 mmHg | Standard Deviation 2.31 |
| Control Group | Mean Mitral Valve Gradient | 3.54 mmHg | Standard Deviation 4.27 |
Other Pre-specified
Mitral Stenosis
Defined as a mitral valve orifice area of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory
Time frame: 4 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Mitral Stenosis | 23 Participants |
| Control Group | Mitral Stenosis | 2 Participants |
Other Pre-specified
Mitral Stenosis
Defined as a mitral valve orifice area of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Mitral Stenosis | 18 Participants |
| Control Group | Mitral Stenosis | 1 Participants |
Other Pre-specified
Mitral Stenosis
Defined as a mitral valve orifice area of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Mitral Stenosis | 23 Participants |
| Control Group | Mitral Stenosis | 0 Participants |
Other Pre-specified
Mitral Stenosis
Defined as a mitral valve orifice area of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Mitral Stenosis | 25 Participants |
| Control Group | Mitral Stenosis | 0 Participants |
Other Pre-specified
Mitral Stenosis
Defined as a mitral valve orifice area of less than 1.5 cm2 as measured by the Echocardiography Core Laboratory
Time frame: 3 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Mitral Stenosis | 22 Participants |
| Control Group | Mitral Stenosis | 1 Participants |
Other Pre-specified
Mitral Valve Area
Time frame: 5 years
Population: All available electrocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Mitral Valve Area | 3.76 cm^2 | Standard Deviation 1.11 |
| Control Group | Mitral Valve Area | 4.33 cm^2 | Standard Deviation 1.31 |
Other Pre-specified
Mitral Valve Area
Time frame: 24 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Mitral Valve Area | 2.85 cm^2 | Standard Deviation 1.01 |
| Control Group | Mitral Valve Area | 4.98 cm^2 | Standard Deviation 1.14 |
Other Pre-specified
Mitral Valve Area
Time frame: 6 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Mitral Valve Area | 2.84 cm^2 | Standard Deviation 1.1 |
| Control Group | Mitral Valve Area | 4.94 cm^2 | Standard Deviation 1 |
Other Pre-specified
Mitral Valve Area
Time frame: 12 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Mitral Valve Area | 2.67 cm^2 | Standard Deviation 0.86 |
| Control Group | Mitral Valve Area | 4.88 cm^2 | Standard Deviation 0.95 |
Other Pre-specified
Mitral Valve Area
Time frame: At discharge (or 30 days if discharge echocardiogram is not available)
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Mitral Valve Area | 2.68 cm^2 | Standard Deviation 0.92 |
| Control Group | Mitral Valve Area | 4.81 cm^2 | Standard Deviation 1 |
Other Pre-specified
Mitral Valve Area
Time frame: Baseline
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Mitral Valve Area | 5.17 cm^2 | Standard Deviation 1.26 |
| Control Group | Mitral Valve Area | 5.16 cm^2 | Standard Deviation 1.16 |
Other Pre-specified
Mitral Valve Area
Time frame: 3 years
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Mitral Valve Area | 3.06 cm^2 | Standard Deviation 0.9 |
| Control Group | Mitral Valve Area | 4.47 cm^2 | Standard Deviation 1.58 |
Other Pre-specified
Mitral Valve Area
Time frame: 4 years
Population: All electrocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Mitral Valve Area | 3.27 cm^2 | Standard Deviation 0.79 |
| Control Group | Mitral Valve Area | 4.39 cm^2 | Standard Deviation 1.41 |
Other Pre-specified
Mitral Valve Replacement Rates
summarized and compared between Device and Control groups
Time frame: 4 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Mitral Valve Replacement Rates | 1 Participants |
| Control Group | Mitral Valve Replacement Rates | 5 Participants |
Other Pre-specified
Mitral Valve Replacement Rates
Subjects with mitral valve replacements in the Device and Control groups
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Mitral Valve Replacement Rates | 1 Participants |
| Control Group | Mitral Valve Replacement Rates | 5 Participants |
Other Pre-specified
Mitral Valve Replacement Rates
summarized and compared between Device and Control groups
Time frame: 3 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Mitral Valve Replacement Rates | 1 Participants |
| Control Group | Mitral Valve Replacement Rates | 5 Participants |
Other Pre-specified
Mitral Valve Replacement Rates
summarized and compared between Device and Control groups
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Mitral Valve Replacement Rates | 1 Participants |
| Control Group | Mitral Valve Replacement Rates | 5 Participants |
Other Pre-specified
Mitral Valve Replacement Rates
Subjects with mitral valve replacements in the Device and Control groups
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Mitral Valve Replacement Rates | 1 Participants |
| Control Group | Mitral Valve Replacement Rates | 5 Participants |
Other Pre-specified
Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group
Time frame: Through 5 years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group | Additional MitraClip Device Intervention | 10 Participants |
| MitraClip System | Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group | New use of single or dual chamber Pacemaker | 10 Participants |
| MitraClip System | Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group | Mitral Valve Surgery Elective - Repair | 0 Participants |
| MitraClip System | Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group | New Use of CRT | 8 Participants |
| MitraClip System | Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group | Mitral Valve Surgery Elective - Replacement | 1 Participants |
| MitraClip System | Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group | Permanent LVAD Implant | 16 Participants |
| MitraClip System | Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group | Mitral Valve Surgery Non Elective - Repair | 0 Participants |
| MitraClip System | Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group | Heart Transplant | 9 Participants |
| MitraClip System | Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group | Mitral Valve Surgery Non Elective - Replacement | 0 Participants |
| Control Group | Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group | Heart Transplant | 11 Participants |
| Control Group | Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group | Mitral Valve Surgery Non Elective - Replacement | 0 Participants |
| Control Group | Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group | New Use of CRT | 11 Participants |
| Control Group | Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group | New use of single or dual chamber Pacemaker | 10 Participants |
| Control Group | Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group | Permanent LVAD Implant | 18 Participants |
| Control Group | Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group | Additional MitraClip Device Intervention | NA Participants |
| Control Group | Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group | Mitral Valve Surgery Elective - Repair | 3 Participants |
| Control Group | Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group | Mitral Valve Surgery Elective - Replacement | 5 Participants |
| Control Group | Mitral Valve Surgery (Including Type of Surgery), New Use of CRT, New Use of Single or Dual Chamber Pacemaker, Permanent LVAD Implant, Heart Transplant, Additional MitraClip Device Intervention in Device Group | Mitral Valve Surgery Non Elective - Repair | 0 Participants |
Other Pre-specified
Modified Rankin Scale Score
MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Modified Rankin Scale Score | 0 | 145 Participants |
| MitraClip System | Modified Rankin Scale Score | 1 | 60 Participants |
| MitraClip System | Modified Rankin Scale Score | 2 | 30 Participants |
| MitraClip System | Modified Rankin Scale Score | 3 | 13 Participants |
| MitraClip System | Modified Rankin Scale Score | 4 | 2 Participants |
| MitraClip System | Modified Rankin Scale Score | 5 | 0 Participants |
| Control Group | Modified Rankin Scale Score | 4 | 8 Participants |
| Control Group | Modified Rankin Scale Score | 0 | 120 Participants |
| Control Group | Modified Rankin Scale Score | 3 | 20 Participants |
| Control Group | Modified Rankin Scale Score | 1 | 48 Participants |
| Control Group | Modified Rankin Scale Score | 5 | 0 Participants |
| Control Group | Modified Rankin Scale Score | 2 | 38 Participants |
Other Pre-specified
Modified Rankin Scale Score
MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead
Time frame: 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Modified Rankin Scale Score | 2 | 34 Participants |
| MitraClip System | Modified Rankin Scale Score | 1 | 42 Participants |
| MitraClip System | Modified Rankin Scale Score | 0 | 134 Participants |
| MitraClip System | Modified Rankin Scale Score | 3 | 9 Participants |
| MitraClip System | Modified Rankin Scale Score | 4 | 0 Participants |
| MitraClip System | Modified Rankin Scale Score | 5 | 0 Participants |
| Control Group | Modified Rankin Scale Score | 4 | 7 Participants |
| Control Group | Modified Rankin Scale Score | 3 | 14 Participants |
| Control Group | Modified Rankin Scale Score | 1 | 40 Participants |
| Control Group | Modified Rankin Scale Score | 5 | 1 Participants |
| Control Group | Modified Rankin Scale Score | 0 | 100 Participants |
| Control Group | Modified Rankin Scale Score | 2 | 27 Participants |
Other Pre-specified
Modified Rankin Scale Score
MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead
Time frame: 30 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Modified Rankin Scale Score | 0 | 169 Participants |
| MitraClip System | Modified Rankin Scale Score | 1 | 56 Participants |
| MitraClip System | Modified Rankin Scale Score | 2 | 40 Participants |
| MitraClip System | Modified Rankin Scale Score | 3 | 13 Participants |
| MitraClip System | Modified Rankin Scale Score | 4 | 0 Participants |
| MitraClip System | Modified Rankin Scale Score | 5 | 0 Participants |
| Control Group | Modified Rankin Scale Score | 4 | 8 Participants |
| Control Group | Modified Rankin Scale Score | 0 | 129 Participants |
| Control Group | Modified Rankin Scale Score | 3 | 34 Participants |
| Control Group | Modified Rankin Scale Score | 1 | 54 Participants |
| Control Group | Modified Rankin Scale Score | 5 | 2 Participants |
| Control Group | Modified Rankin Scale Score | 2 | 49 Participants |
Other Pre-specified
Modified Rankin Scale Score
MODIFIED RANKIN SCALE SCORE DESCRIPTIONS: 0- No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities; 2- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- Moderate disability; requiring some help, but able to walk without assistance; 4- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5- Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- Dead
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Modified Rankin Scale Score | 3 | 23 Participants |
| MitraClip System | Modified Rankin Scale Score | 5 | 0 Participants |
| MitraClip System | Modified Rankin Scale Score | 2 | 55 Participants |
| MitraClip System | Modified Rankin Scale Score | 0 | 170 Participants |
| MitraClip System | Modified Rankin Scale Score | 4 | 2 Participants |
| MitraClip System | Modified Rankin Scale Score | 1 | 52 Participants |
| Control Group | Modified Rankin Scale Score | 4 | 2 Participants |
| Control Group | Modified Rankin Scale Score | 2 | 58 Participants |
| Control Group | Modified Rankin Scale Score | 3 | 35 Participants |
| Control Group | Modified Rankin Scale Score | 1 | 55 Participants |
| Control Group | Modified Rankin Scale Score | 5 | 0 Participants |
| Control Group | Modified Rankin Scale Score | 0 | 158 Participants |
Other Pre-specified
MR Severity Grade
MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume \< 30 ml, Right ventricular EF \<30%, Effective regurgitant orifice area \< 20 mm\^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm\^2 MR 3+ -Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm\^2 MR 4+ - Regurgitant Volume \>= 60 ml, Right ventricular EF \>=50%, Effective regurgitant orifice area \>=40 mm\^2
Time frame: 4 years
Population: Echocardiogram data was available for 80 subjects in the device arm and 49 subjects in the control arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | MR Severity Grade | MR 3+ | 2 Participants |
| MitraClip System | MR Severity Grade | MR 2+ | 14 Participants |
| MitraClip System | MR Severity Grade | MR 4+ | 0 Participants |
| MitraClip System | MR Severity Grade | MR None or 1+ | 64 Participants |
| Control Group | MR Severity Grade | MR 4+ | 4 Participants |
| Control Group | MR Severity Grade | MR 2+ | 9 Participants |
| Control Group | MR Severity Grade | MR 3+ | 6 Participants |
| Control Group | MR Severity Grade | MR None or 1+ | 30 Participants |
Other Pre-specified
MR Severity Grade
MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume \< 30 ml, Right ventricular EF \<30%, Effective regurgitant orifice area \< 20 mm\^2 MR2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm\^2 MR3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm\^2MR 4+ - Regurgitant Volume \>= 60 ml, Right ventricular EF \>=50%, Effective regurgitant orifice area \>=40 mm\^2
Time frame: 3 years
Population: Echocardiogram data was available for 120 subjects in the device arm and 74 subjects in the control arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | MR Severity Grade | MR None or 1+ | 100 Participants |
| MitraClip System | MR Severity Grade | MR 2+ | 18 Participants |
| MitraClip System | MR Severity Grade | MR 3+ | 2 Participants |
| MitraClip System | MR Severity Grade | MR 4+ | 0 Participants |
| Control Group | MR Severity Grade | MR 4+ | 3 Participants |
| Control Group | MR Severity Grade | MR None or 1+ | 48 Participants |
| Control Group | MR Severity Grade | MR 3+ | 8 Participants |
| Control Group | MR Severity Grade | MR 2+ | 15 Participants |
Other Pre-specified
MR Severity Grade
MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume \< 30 ml, Right ventricular EF \<30%, Effective regurgitant orifice area \< 20 mm\^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm\^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm\^2 MR 4+ - Regurgitant Volume \>= 60 ml, Right ventricular EF \>=50%, Effective regurgitant orifice area \>=40 mm\^2
Time frame: 24 months
Population: Echocardiogram data was available for 167 subjects in the device arm and 126 subjects in the control arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | MR Severity Grade | MR None or 1+ | 131 Participants |
| MitraClip System | MR Severity Grade | MR 2+ | 35 Participants |
| MitraClip System | MR Severity Grade | MR 3+ | 0 Participants |
| MitraClip System | MR Severity Grade | MR 4+ | 1 Participants |
| Control Group | MR Severity Grade | MR 4+ | 24 Participants |
| Control Group | MR Severity Grade | MR None or 1+ | 23 Participants |
| Control Group | MR Severity Grade | MR 3+ | 43 Participants |
| Control Group | MR Severity Grade | MR 2+ | 36 Participants |
Other Pre-specified
MR Severity Grade
MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume \< 30 ml, Right ventricular EF \<30%, Effective regurgitant orifice area \< 20 mm\^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm\^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm\^2 MR 4+ - Regurgitant Volume \>= 60 ml, Right ventricular EF \>=50%, Effective regurgitant orifice area \>=40 mm\^2
Time frame: Baseline
Population: echocardiogram data was available for 302 subjects in the device arm and 311 subjects in the control arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | MR Severity Grade | MR 3+ | 148 Participants |
| MitraClip System | MR Severity Grade | MR 4+ | 154 Participants |
| Control Group | MR Severity Grade | MR 3+ | 172 Participants |
| Control Group | MR Severity Grade | MR 4+ | 139 Participants |
Other Pre-specified
MR Severity Grade
MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume \< 30 ml, Right ventricular EF \<30%, Effective regurgitant orifice area \< 20 mm\^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm\^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm\^2 MR 4+ - Regurgitant Volume \>= 60 ml, Right ventricular EF \>=50%, Effective regurgitant orifice area \>=40 mm\^2
Time frame: 12 months
Population: Echocardiogram data was available for 210 subjects in the device arm and 175 subjects in the control arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | MR Severity Grade | MR None or 1+ | 145 Participants |
| MitraClip System | MR Severity Grade | MR 2+ | 54 Participants |
| MitraClip System | MR Severity Grade | MR 3+ | 9 Participants |
| MitraClip System | MR Severity Grade | MR 4+ | 2 Participants |
| Control Group | MR Severity Grade | MR 4+ | 33 Participants |
| Control Group | MR Severity Grade | MR None or 1+ | 20 Participants |
| Control Group | MR Severity Grade | MR 3+ | 60 Participants |
| Control Group | MR Severity Grade | MR 2+ | 62 Participants |
Other Pre-specified
MR Severity Grade
MR Severity Grading was done by Quantitative Doppler Echocardiography andsubjects were graded as below MR 1+ - Regurgitant Volume \< 30 ml, Right ventricular EF \<30%, Effectiveregurgitant orifice area \< 20 mm\^2 MR 2+ - Regurgitant Volume 30-44 ml, Rightventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm\^2 MR 3+ -Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitantorifice area 30-39 mm\^2 MR 4+ - Regurgitant Volume \>= 60 ml, Right ventricularEF \>=50%, Effective regurgitant orifice area \>=40 mm\^2
Time frame: 5 years
Population: Echocardiogram data was available for 57 subjects in the device arm and 46 subjects in the control arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | MR Severity Grade | MR None or 1+ | 51 Participants |
| MitraClip System | MR Severity Grade | MR 3+ | 3 Participants |
| MitraClip System | MR Severity Grade | MR 4+ | 0 Participants |
| MitraClip System | MR Severity Grade | MR 2+ | 3 Participants |
| Control Group | MR Severity Grade | MR 4+ | 2 Participants |
| Control Group | MR Severity Grade | MR None or 1+ | 36 Participants |
| Control Group | MR Severity Grade | MR 2+ | 6 Participants |
| Control Group | MR Severity Grade | MR 3+ | 2 Participants |
Other Pre-specified
MR Severity Grade
MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume \< 30 ml, Right ventricular EF \<30%, Effective regurgitant orifice area \< 20 mm\^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm\^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm\^2 MR 4+ - Regurgitant Volume \>= 60 ml, Right ventricular EF \>=50%, Effective regurgitant orifice area \>=40 mm\^2
Time frame: At discharge (or 30 days if discharge echocardiogram is not available)
Population: Echocardiogram data was available for 286 subjects in the device arm and 257 subjects in the control arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | MR Severity Grade | MR None or 1+ | 230 Participants |
| MitraClip System | MR Severity Grade | MR 2+ | 39 Participants |
| MitraClip System | MR Severity Grade | MR 3+ | 13 Participants |
| MitraClip System | MR Severity Grade | MR 4+ | 4 Participants |
| Control Group | MR Severity Grade | MR 4+ | 73 Participants |
| Control Group | MR Severity Grade | MR None or 1+ | 21 Participants |
| Control Group | MR Severity Grade | MR 3+ | 96 Participants |
| Control Group | MR Severity Grade | MR 2+ | 67 Participants |
Other Pre-specified
MR Severity Grade
MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below MR 1+ - Regurgitant Volume \< 30 ml, Right ventricular EF \<30%, Effective regurgitant orifice area \< 20 mm\^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm\^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm\^2 MR 4+ - Regurgitant Volume \>= 60 ml, Right ventricular EF \>=50%, Effective regurgitant orifice area \>=40 mm\^2
Time frame: 6 months
Population: Echocardiogram data was available for only 240 subjects in the device group and 218 subjects in the control group
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | MR Severity Grade | MR none or 1+ | 160 Participants |
| MitraClip System | MR Severity Grade | MR 2+ | 65 Participants |
| MitraClip System | MR Severity Grade | MR 3+ | 11 Participants |
| MitraClip System | MR Severity Grade | MR 4+ | 4 Participants |
| Control Group | MR Severity Grade | MR 4+ | 43 Participants |
| Control Group | MR Severity Grade | MR none or 1+ | 20 Participants |
| Control Group | MR Severity Grade | MR 3+ | 92 Participants |
| Control Group | MR Severity Grade | MR 2+ | 63 Participants |
Other Pre-specified
New Onset of Permanent Atrial Fibrillation
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | New Onset of Permanent Atrial Fibrillation | 23 Participants |
| Control Group | New Onset of Permanent Atrial Fibrillation | 23 Participants |
Other Pre-specified
New Onset of Permanent Atrial Fibrillation
Time frame: 4 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | New Onset of Permanent Atrial Fibrillation | 23 Participants |
| Control Group | New Onset of Permanent Atrial Fibrillation | 20 Participants |
Other Pre-specified
New Onset of Permanent Atrial Fibrillation
Time frame: 3 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | New Onset of Permanent Atrial Fibrillation | 22 Participants |
| Control Group | New Onset of Permanent Atrial Fibrillation | 20 Participants |
Other Pre-specified
New Onset of Permanent Atrial Fibrillation
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | New Onset of Permanent Atrial Fibrillation | 18 Participants |
| Control Group | New Onset of Permanent Atrial Fibrillation | 15 Participants |
Other Pre-specified
New Onset of Permanent Atrial Fibrillation
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | New Onset of Permanent Atrial Fibrillation | 14 Participants |
| Control Group | New Onset of Permanent Atrial Fibrillation | 13 Participants |
Other Pre-specified
Number of Days Alive and Out of Hospital
difference in medians between Device and Control groups
Time frame: From the time of randomization to 5 Years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Number of Days Alive and Out of Hospital | 1123.5 Number of Days | Standard Deviation 664.8 |
| Control Group | Number of Days Alive and Out of Hospital | 894.8 Number of Days | Standard Deviation 655.1 |
Other Pre-specified
Number of Days Alive and Out of Hospital
Mean Number of days alive and out of hospital for the Device and Control groups
Time frame: From the time of randomization to 3 Years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Number of Days Alive and Out of Hospital | 799.0 Number of Days | Standard Deviation 380.9 |
| Control Group | Number of Days Alive and Out of Hospital | 676.6 Number of Days | Standard Deviation 389.9 |
Other Pre-specified
Number of Days Alive and Out of Hospital
mean Number of days alive and out of hospital for the Device and Control groups
Time frame: From the time of randomization to 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Number of Days Alive and Out of Hospital | 579.4 Number of Days | Standard Deviation 234 |
| Control Group | Number of Days Alive and Out of Hospital | 521.1 Number of Days | Standard Deviation 245 |
Other Pre-specified
Number of Days Alive and Out of Hospital
mean no of days alive and out of hospital in both Device and Control groups
Time frame: From the time of randomization to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Number of Days Alive and Out of Hospital | 316.6 Number of days | Standard Deviation 93.9 |
| Control Group | Number of Days Alive and Out of Hospital | 305.4 Number of days | Standard Deviation 98.6 |
Other Pre-specified
Number of Days Alive and Out of Hospital
difference in medians between Device and Control groups
Time frame: From the time of randomization to 4 Years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Number of Days Alive and Out of Hospital | 979.3 Number of Days | Standard Deviation 527.4 |
| Control Group | Number of Days Alive and Out of Hospital | 797.5 Number of Days | Standard Deviation 527.4 |
Other Pre-specified
Number of Days Hospitalized From the Treatment Visit
mean Number of days hospitalized from the Treatment visit for the Device and Control groups
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Number of Days Hospitalized From the Treatment Visit | 13.0 Number of Days | Standard Deviation 20 |
| Control Group | Number of Days Hospitalized From the Treatment Visit | 13.9 Number of Days | Standard Deviation 19.8 |
Other Pre-specified
Number of Days Hospitalized From the Treatment Visit
mean Number of days hospitalized from the Treatment visit for the Device and Control groups
Time frame: 3 Years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Number of Days Hospitalized From the Treatment Visit | 18.4 Number of Days | Standard Deviation 28.3 |
| Control Group | Number of Days Hospitalized From the Treatment Visit | 17.5 Number of Days | Standard Deviation 22.7 |
Other Pre-specified
Number of Days Hospitalized From the Treatment Visit
mean Number of days hospitalized from the Treatment visit for the Device and Control groups
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Number of Days Hospitalized From the Treatment Visit | 9.2 Number of Days | Standard Deviation 14.7 |
| Control Group | Number of Days Hospitalized From the Treatment Visit | 9.6 Number of Days | Standard Deviation 16.9 |
Other Pre-specified
Number of Days Hospitalized From the Treatment Visit
difference in medians between Device and Control groups
Time frame: 5 Years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Number of Days Hospitalized From the Treatment Visit | 23.8 Number of Days | Standard Deviation 33.7 |
| Control Group | Number of Days Hospitalized From the Treatment Visit | 19.8 Number of Days | Standard Deviation 24.1 |
Other Pre-specified
Number of Days Hospitalized From the Treatment Visit
difference in medians between Device and Control groups
Time frame: 4 Years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Number of Days Hospitalized From the Treatment Visit | 21.3 Number of Days | Standard Deviation 31.1 |
| Control Group | Number of Days Hospitalized From the Treatment Visit | 19.0 Number of Days | Standard Deviation 23.9 |
Other Pre-specified
Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular)
in each of the Device and Control groups
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular) | Heart Failure | 70 Participants |
| MitraClip System | Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular) | Cardiovascular | 52 Participants |
| MitraClip System | Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular) | Non-Cardiovascular | 95 Participants |
| Control Group | Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular) | Heart Failure | 118 Participants |
| Control Group | Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular) | Cardiovascular | 54 Participants |
| Control Group | Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular) | Non-Cardiovascular | 97 Participants |
Other Pre-specified
Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular)
in each of the Device and Control groups
Time frame: 24 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular) | Heart Failure | 92 Participants |
| MitraClip System | Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular) | Cardiovascular | 72 Participants |
| MitraClip System | Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular) | Non-Cardiovascular | 124 Participants |
| Control Group | Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular) | Heart Failure | 151 Participants |
| Control Group | Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular) | Cardiovascular | 72 Participants |
| Control Group | Number of Hospitalizations and Reason for Hospitalization (i.e. Heart Failure, Cardiovascular, Non-cardiovascular) | Non-Cardiovascular | 128 Participants |
Other Pre-specified
NYHA Functional Class
Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | NYHA Functional Class | NYHA Class I | 51 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class II | 139 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class III | 56 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class IV | 7 Participants |
| Control Group | NYHA Functional Class | NYHA Class IV | 7 Participants |
| Control Group | NYHA Functional Class | NYHA Class I | 14 Participants |
| Control Group | NYHA Functional Class | NYHA Class III | 100 Participants |
| Control Group | NYHA Functional Class | NYHA Class II | 117 Participants |
Other Pre-specified
NYHA Functional Class
Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations
Time frame: Baseline
Population: NYHA Class data available for only 311 subjects
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | NYHA Functional Class | NYHA Class I | 1 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class II | 129 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class III | 154 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class IV | 18 Participants |
| Control Group | NYHA Functional Class | NYHA Class IV | 33 Participants |
| Control Group | NYHA Functional Class | NYHA Class I | 0 Participants |
| Control Group | NYHA Functional Class | NYHA Class III | 168 Participants |
| Control Group | NYHA Functional Class | NYHA Class II | 110 Participants |
Other Pre-specified
NYHA Functional Class
Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations
Time frame: 30 days
Population: All available data at 30 day follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | NYHA Functional Class | NYHA Class I | 44 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class III | 55 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class II | 172 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class IV | 10 Participants |
| Control Group | NYHA Functional Class | NYHA Class IV | 27 Participants |
| Control Group | NYHA Functional Class | NYHA Class I | 14 Participants |
| Control Group | NYHA Functional Class | NYHA Class II | 120 Participants |
| Control Group | NYHA Functional Class | NYHA Class III | 117 Participants |
Other Pre-specified
NYHA Functional Class
Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations
Time frame: 12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | NYHA Functional Class | NYHA Class III | 42 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class II | 131 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class IV | 6 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class I | 40 Participants |
| Control Group | NYHA Functional Class | NYHA Class IV | 11 Participants |
| Control Group | NYHA Functional Class | NYHA Class II | 97 Participants |
| Control Group | NYHA Functional Class | NYHA Class III | 65 Participants |
| Control Group | NYHA Functional Class | NYHA Class I | 18 Participants |
Other Pre-specified
NYHA Functional Class
Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity: Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due to symptoms Class IV: Severe limitations
Time frame: 24 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | NYHA Functional Class | NYHA Class II | 91 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class III | 44 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class IV | 10 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class I | 31 Participants |
| Control Group | NYHA Functional Class | NYHA Class IV | 8 Participants |
| Control Group | NYHA Functional Class | NYHA Class I | 12 Participants |
| Control Group | NYHA Functional Class | NYHA Class III | 54 Participants |
| Control Group | NYHA Functional Class | NYHA Class II | 69 Participants |
Other Pre-specified
NYHA Functional Class
Measure Description: The New York Heart Association (NYHA) Classification provides a simple way of classifyingthe extent of heart failure. It classifies patients in one of four categories based on their limitations during physicalactivity: Class I: No symptoms and no limitation in ordinary physical activity Class II: Mild symptoms (mild shortness ofbreath and/or angina) and slight limitation during ordinary activity Class III: Marked limitation in activity due tosymptoms Class IV: Severe limitations
Time frame: 3 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | NYHA Functional Class | NYHA Class I | 25 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class II | 85 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class III | 32 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class IV | 4 Participants |
| Control Group | NYHA Functional Class | NYHA Class IV | 6 Participants |
| Control Group | NYHA Functional Class | NYHA Class I | 16 Participants |
| Control Group | NYHA Functional Class | NYHA Class III | 32 Participants |
| Control Group | NYHA Functional Class | NYHA Class II | 48 Participants |
Other Pre-specified
NYHA Functional Class
Time frame: 4 years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | NYHA Functional Class | NYHA Class I | 21 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class II | 70 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class III | 29 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class IV | 5 Participants |
| Control Group | NYHA Functional Class | NYHA Class IV | 5 Participants |
| Control Group | NYHA Functional Class | NYHA Class I | 10 Participants |
| Control Group | NYHA Functional Class | NYHA Class III | 25 Participants |
| Control Group | NYHA Functional Class | NYHA Class II | 36 Participants |
Other Pre-specified
NYHA Functional Class
Time frame: 5 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | NYHA Functional Class | NYHA Class I | 17 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class II | 45 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class III | 28 Participants |
| MitraClip System | NYHA Functional Class | NYHA Class IV | 4 Participants |
| Control Group | NYHA Functional Class | NYHA Class IV | 0 Participants |
| Control Group | NYHA Functional Class | NYHA Class I | 12 Participants |
| Control Group | NYHA Functional Class | NYHA Class III | 26 Participants |
| Control Group | NYHA Functional Class | NYHA Class II | 27 Participants |
Other Pre-specified
Prolonged Ventilation
Defined as pulmonary insufficiency requiring ventilatory support for greater than 48 hours post-catheterization
Time frame: 30 days
Other Pre-specified
Proportion of Alive Time in Hospital
summarized and compared between Device and Control groups
Time frame: 5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Proportion of Alive Time in Hospital | 0.05 Number of Days | Standard Deviation 0.1 |
| Control Group | Proportion of Alive Time in Hospital | 0.05 Number of Days | Standard Deviation 0.08 |
Other Pre-specified
Proportion of Alive Time in Hospital
summarized and compared between Device and Control groups
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Proportion of Alive Time in Hospital | 0.04 Number of Days | Standard Deviation 0.1 |
| Control Group | Proportion of Alive Time in Hospital | 0.04 Number of Days | Standard Deviation 0.08 |
Other Pre-specified
Proportion of Alive Time in Hospital
summarized and compared between Device and Control groups
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Proportion of Alive Time in Hospital | 0.05 Number of Days | Standard Deviation 0.1 |
| Control Group | Proportion of Alive Time in Hospital | 0.04 Number of Days | Standard Deviation 0.09 |
Other Pre-specified
Proportion of Alive Time in Hospital
summarized and compared between Device and Control groups
Time frame: 3 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Proportion of Alive Time in Hospital | 0.05 Number of Days | Standard Deviation 0.1 |
| Control Group | Proportion of Alive Time in Hospital | 0.05 Number of Days | Standard Deviation 0.08 |
Other Pre-specified
Proportion of Alive Time in Hospital
summarized and compared between Device and Control groups
Time frame: 4 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Proportion of Alive Time in Hospital | 0.05 Number of Days | Standard Deviation 0.1 |
| Control Group | Proportion of Alive Time in Hospital | 0.05 Number of Days | Standard Deviation 0.08 |
Other Pre-specified
Proportion of Subjects Living in the Baseline Location
Subjects living in the baseline location include : home, retirement home, nursing facility and other location.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Proportion of Subjects Living in the Baseline Location | 217 Participants |
| Control Group | Proportion of Subjects Living in the Baseline Location | 198 Participants |
Other Pre-specified
Proportion of Subjects Living in the Baseline Location
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Proportion of Subjects Living in the Baseline Location | 98 Participants |
| Control Group | Proportion of Subjects Living in the Baseline Location | 72 Participants |
Other Pre-specified
Proportion of Subjects Living in the Baseline Location
Time frame: 3 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Proportion of Subjects Living in the Baseline Location | 150 Participants |
| Control Group | Proportion of Subjects Living in the Baseline Location | 108 Participants |
Other Pre-specified
Proportion of Subjects Living in the Baseline Location
Time frame: 4 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Proportion of Subjects Living in the Baseline Location | 129 Participants |
| Control Group | Proportion of Subjects Living in the Baseline Location | 86 Participants |
Other Pre-specified
Proportion of Subjects Living in the Baseline Location
Subjects living in the baseline location include : home, retirement home, nursing facility and other location.
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Proportion of Subjects Living in the Baseline Location | 130 Participants |
| Control Group | Proportion of Subjects Living in the Baseline Location | 87 Participants |
Other Pre-specified
Regurgitant Fraction
Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.
Time frame: 6 months
Population: Echocardiogram data was available for 45 subjects in the device arm and 54 subjects in the control arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Regurgitant Fraction | 34.14 percentage | Standard Deviation 15.89 |
| Control Group | Regurgitant Fraction | 42.20 percentage | Standard Deviation 14.49 |
Other Pre-specified
Regurgitant Fraction
Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.
Time frame: 4 years
Population: Echocardiogram data was available for 11 subjects in the device arm and 5 subjects in the control arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Regurgitant Fraction | 32.00 percentage | Standard Deviation 7.72 |
| Control Group | Regurgitant Fraction | 38.80 percentage | Standard Deviation 21.51 |
Other Pre-specified
Regurgitant Fraction
Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.
Time frame: At discharge (or 30 days if discharge echocardiogram is not available)
Population: Echocardiogram data was available for 85 subjects in the device arm and 70 subjects in the control arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Regurgitant Fraction | 31.00 percentage | Standard Deviation 14.53 |
| Control Group | Regurgitant Fraction | 35.29 percentage | Standard Deviation 15.32 |
Other Pre-specified
Regurgitant Fraction
Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.
Time frame: Baseline
Population: Echocardiogram data was available for 123 subjects in the device group and 136 subjects in the control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Regurgitant Fraction | 38.24 percentage | Standard Deviation 13.81 |
| Control Group | Regurgitant Fraction | 34.81 percentage | Standard Deviation 14.94 |
Other Pre-specified
Regurgitant Fraction
Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricledue to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.
Time frame: 3 years
Population: Echocardiogram data is available for 20 subjects in the device arm and 17 subjects in the control arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Regurgitant Fraction | 31.00 percentage | Standard Deviation 12.38 |
| Control Group | Regurgitant Fraction | 38.71 percentage | Standard Deviation 10.21 |
Other Pre-specified
Regurgitant Fraction
Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.
Time frame: 24 months
Population: Echocardiogram data is available for 21 subjects in the device arm and 28 subjects in the control arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Regurgitant Fraction | 34.29 percentage | Standard Deviation 14.52 |
| Control Group | Regurgitant Fraction | 41.79 percentage | Standard Deviation 14.93 |
Other Pre-specified
Regurgitant Fraction
Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.
Time frame: 12 months
Population: Echocardiogram data was available for 33 subjects in the device arm and 45 subjects in the control arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Regurgitant Fraction | 32.15 percentage | Standard Deviation 13.06 |
| Control Group | Regurgitant Fraction | 37.80 percentage | Standard Deviation 15.49 |
Other Pre-specified
Regurgitant Fraction
Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency
Time frame: 5 years
Population: Echocardiogram data is available for 9 subjects in the device arm and 9 subjects in the control arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Regurgitant Fraction | 37.78 percentage | Standard Deviation 12.77 |
| Control Group | Regurgitant Fraction | 32.78 percentage | Standard Deviation 9.2 |
Other Pre-specified
Regurgitant Volume
Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.
Time frame: 24 months
Population: Echocardiogram data was available for 21 subjects in the device arm and 28 subjects in the control arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Regurgitant Volume | 21.48 ml/beat | Standard Deviation 11.34 |
| Control Group | Regurgitant Volume | 32.96 ml/beat | Standard Deviation 16.04 |
Other Pre-specified
Regurgitant Volume
Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.
Time frame: 12 months
Population: Echocardiogram data was available for 33 subjects in the device arm and 45 subjects in the control arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Regurgitant Volume | 21.61 ml/beat | Standard Deviation 12.12 |
| Control Group | Regurgitant Volume | 27.76 ml/beat | Standard Deviation 14.35 |
Other Pre-specified
Regurgitant Volume
Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from theLeft Ventricular Outflow Tract (LVOT) stroke volume during systole.
Time frame: 3 years
Population: Echocardiogram data was available for 20 subjects in the device arm and 17 subjects in the control arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Regurgitant Volume | 18.80 ml/beat | Standard Deviation 9.61 |
| Control Group | Regurgitant Volume | 24.65 ml/beat | Standard Deviation 12.26 |
Other Pre-specified
Regurgitant Volume
Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.
Time frame: 4 years
Population: Echocardiogram data was available for 11 subjects in the device arm and 5 subjects in the control arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Regurgitant Volume | 18.36 ml/beat | Standard Deviation 6.27 |
| Control Group | Regurgitant Volume | 23.00 ml/beat | Standard Deviation 14.47 |
Other Pre-specified
Regurgitant Volume
Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.
Time frame: 5 years
Population: Echocardiogram data was available for 9 subjects in the device arm and 9 subjects in the control arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Regurgitant Volume | 21.11 ml/beat | Standard Deviation 10.11 |
| Control Group | Regurgitant Volume | 18.78 ml/beat | Standard Deviation 5.95 |
Other Pre-specified
Regurgitant Volume
Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.
Time frame: Baseline
Population: Echocardiogram data was available for 124 subjects in the device arm and 136 subjects in the control arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Regurgitant Volume | 28.80 ml/beat | Standard Deviation 16.99 |
| Control Group | Regurgitant Volume | 25.01 ml/beat | Standard Deviation 15.31 |
Other Pre-specified
Regurgitant Volume
Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.
Time frame: At discharge (or 30 days if discharge echocardiogram is not available)
Population: Echocardiogram data was available for 85 subjects in device arm and 70 subjects in control arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Regurgitant Volume | 20.04 ml/beat | Standard Deviation 11.86 |
| Control Group | Regurgitant Volume | 25.97 ml/beat | Standard Deviation 15.68 |
Other Pre-specified
Regurgitant Volume
Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.
Time frame: 6 months
Population: Echocardiogram data was available for 45 subjects in the device arm and 54 subjects in the control arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Regurgitant Volume | 23.60 ml/beat | Standard Deviation 16 |
| Control Group | Regurgitant Volume | 32.59 ml/beat | Standard Deviation 15.82 |
Other Pre-specified
Responder Analysis for 6MWD
Where responder is defined as alive and experiencing an improvement of 24 meters and 50 meters (difference in proportion of responders between Device and Control groups)
Time frame: 24 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Responder Analysis for 6MWD | Experiencing Improvement >= 24 meters | 44 Participants |
| MitraClip System | Responder Analysis for 6MWD | Experiencing Improvement >= 50 meters | 34 Participants |
| Control Group | Responder Analysis for 6MWD | Experiencing Improvement >= 24 meters | 34 Participants |
| Control Group | Responder Analysis for 6MWD | Experiencing Improvement >= 50 meters | 23 Participants |
Other Pre-specified
Responder Analysis for 6MWD
Where responder is defined as alive and experiencing an improvement of 24 meters and 50 meters (difference in proportion of responders between Device and Control groups)
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Responder Analysis for 6MWD | Experiencing Improvement >= 24 meters | 100 Participants |
| MitraClip System | Responder Analysis for 6MWD | Experiencing Improvement >= 50 meters | 75 Participants |
| Control Group | Responder Analysis for 6MWD | Experiencing Improvement >= 24 meters | 66 Participants |
| Control Group | Responder Analysis for 6MWD | Experiencing Improvement >= 50 meters | 42 Participants |
Other Pre-specified
Responder Analysis for LVEDV Index
Where responder is defined as alive and experiencing an improvement of 12 ml/m2 (difference in proportion of responders between Device and Control groups)
Time frame: 4 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Responder Analysis for LVEDV Index | 13 Participants |
| Control Group | Responder Analysis for LVEDV Index | 6 Participants |
Other Pre-specified
Responder Analysis for LVEDV Index
Where responder is defined as alive and experiencing an improvement of 12 ml/m2 (difference in proportion of responders between Device and Control groups)
Time frame: 3 years
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Responder Analysis for LVEDV Index | 20 Participants |
| Control Group | Responder Analysis for LVEDV Index | 8 Participants |
Other Pre-specified
Responder Analysis for LVEDV Index
Where responder is defined as alive and experiencing an improvement of 12 ml/m2 (difference in proportion of responders between Device and Control groups)
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Responder Analysis for LVEDV Index | 9 Participants |
| Control Group | Responder Analysis for LVEDV Index | 3 Participants |
Other Pre-specified
Responder Analysis for LVEDV Index
Where responder is defined as alive and experiencing an improvement of 12 ml/m2 (difference in proportion of responders between Device and Control groups)
Time frame: 12 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Responder Analysis for LVEDV Index | 35 Participants |
| Control Group | Responder Analysis for LVEDV Index | 32 Participants |
Other Pre-specified
Responder Analysis for LVEDV Index
Where responder is defined as alive and experiencing an improvement of 12 ml/m2 (difference in proportion of responders between Device and Control groups)
Time frame: 24 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Responder Analysis for LVEDV Index | 26 Participants |
| Control Group | Responder Analysis for LVEDV Index | 20 Participants |
Other Pre-specified
Responder Analysis for QoL (KCCQ)
Where responder is defined as alive and experiencing an improvement of 5 points (difference in proportion of responders between Device and Control groups)
Time frame: 24 months
Population: All available data has been reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Responder Analysis for QoL (KCCQ) | 88 Participants |
| Control Group | Responder Analysis for QoL (KCCQ) | 46 Participants |
Other Pre-specified
Responder Analysis for QoL (KCCQ)
Where responder is defined as alive and experiencing an improvement of 5 points (difference in proportion of responders between Device and Control groups)
Time frame: 12 months
Population: All available data has been reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MitraClip System | Responder Analysis for QoL (KCCQ) | 151 Participants |
| Control Group | Responder Analysis for QoL (KCCQ) | 103 Participants |
Other Pre-specified
Right Ventricular Systolic Pressure (RVSP)
Time frame: At discharge (or 30 days if discharge echocardiogram is not available)
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Right Ventricular Systolic Pressure (RVSP) | 41.41 mmHg | Standard Deviation 11.63 |
| Control Group | Right Ventricular Systolic Pressure (RVSP) | 43.81 mmHg | Standard Deviation 14.24 |
Other Pre-specified
Right Ventricular Systolic Pressure (RVSP)
Time frame: 3 years
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Right Ventricular Systolic Pressure (RVSP) | 37.73 mmHg | Standard Deviation 11.56 |
| Control Group | Right Ventricular Systolic Pressure (RVSP) | 37.57 mmHg | Standard Deviation 13.61 |
Other Pre-specified
Right Ventricular Systolic Pressure (RVSP)
Time frame: 5 years
Population: All available electrocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Right Ventricular Systolic Pressure (RVSP) | 34.85 mmHg | Standard Deviation 12.92 |
| Control Group | Right Ventricular Systolic Pressure (RVSP) | 35.41 mmHg | Standard Deviation 12.12 |
Other Pre-specified
Right Ventricular Systolic Pressure (RVSP)
Time frame: 24 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Right Ventricular Systolic Pressure (RVSP) | 39.46 mmHg | Standard Deviation 12.9 |
| Control Group | Right Ventricular Systolic Pressure (RVSP) | 40.27 mmHg | Standard Deviation 14.92 |
Other Pre-specified
Right Ventricular Systolic Pressure (RVSP)
Time frame: 4 years
Population: All available electrocardiogram data has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Right Ventricular Systolic Pressure (RVSP) | 37.37 mmHg | Standard Deviation 13.04 |
| Control Group | Right Ventricular Systolic Pressure (RVSP) | 39.76 mmHg | Standard Deviation 14.54 |
Other Pre-specified
Right Ventricular Systolic Pressure (RVSP)
Time frame: 12 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Right Ventricular Systolic Pressure (RVSP) | 38.63 mmHg | Standard Deviation 13 |
| Control Group | Right Ventricular Systolic Pressure (RVSP) | 39.31 mmHg | Standard Deviation 13.24 |
Other Pre-specified
Right Ventricular Systolic Pressure (RVSP)
Time frame: 6 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Right Ventricular Systolic Pressure (RVSP) | 40.96 mmHg | Standard Deviation 13.06 |
| Control Group | Right Ventricular Systolic Pressure (RVSP) | 42.21 mmHg | Standard Deviation 14.19 |
Other Pre-specified
Right Ventricular Systolic Pressure (RVSP)
Time frame: Baseline
Population: All available echocardiogram data has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Right Ventricular Systolic Pressure (RVSP) | 43.95 mmHg | Standard Deviation 13.44 |
| Control Group | Right Ventricular Systolic Pressure (RVSP) | 44.56 mmHg | Standard Deviation 13.96 |
Other Pre-specified
SF-36 QoL Scores
The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
Time frame: 12 months
Population: All available data has been reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MitraClip System | SF-36 QoL Scores | SF-36 PCS | 38.7 SF-36 scores on a points scale | Standard Deviation 10.2 |
| MitraClip System | SF-36 QoL Scores | SF-36 MCS | 51.3 SF-36 scores on a points scale | Standard Deviation 10.8 |
| Control Group | SF-36 QoL Scores | SF-36 PCS | 34.6 SF-36 scores on a points scale | Standard Deviation 10.8 |
| Control Group | SF-36 QoL Scores | SF-36 MCS | 48.2 SF-36 scores on a points scale | Standard Deviation 13.8 |
Other Pre-specified
SF-36 QoL Scores
The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
Time frame: Baseline
Population: All available data has been reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MitraClip System | SF-36 QoL Scores | SF-36 PCS | 33.0 SF-36 score on a points scale | Standard Deviation 9.1 |
| MitraClip System | SF-36 QoL Scores | SF-36 MCS | 46.7 SF-36 score on a points scale | Standard Deviation 12.7 |
| Control Group | SF-36 QoL Scores | SF-36 PCS | 32.6 SF-36 score on a points scale | Standard Deviation 10 |
| Control Group | SF-36 QoL Scores | SF-36 MCS | 13.0 SF-36 score on a points scale | Standard Deviation 12 |
Other Pre-specified
SF-36 QoL Scores
The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
Time frame: 30 days
Population: All available data has been reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MitraClip System | SF-36 QoL Scores | SF-36 PCS | 39.2 SF-36 score on a points scale | Standard Deviation 9.2 |
| MitraClip System | SF-36 QoL Scores | SF-36 MCS | 51.4 SF-36 score on a points scale | Standard Deviation 11.5 |
| Control Group | SF-36 QoL Scores | SF-36 PCS | 33.6 SF-36 score on a points scale | Standard Deviation 9.9 |
| Control Group | SF-36 QoL Scores | SF-36 MCS | 46.1 SF-36 score on a points scale | Standard Deviation 13.4 |
Other Pre-specified
SF-36 QoL Scores
The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
Time frame: 24 months
Population: All available data has been reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MitraClip System | SF-36 QoL Scores | SF-36 PCS | 38.7 SF-36 scores on a points scale | Standard Deviation 10.4 |
| MitraClip System | SF-36 QoL Scores | SF-36 MCS | 50.6 SF-36 scores on a points scale | Standard Deviation 12.1 |
| Control Group | SF-36 QoL Scores | SF-36 PCS | 33.7 SF-36 scores on a points scale | Standard Deviation 9.8 |
| Control Group | SF-36 QoL Scores | SF-36 MCS | 47.2 SF-36 scores on a points scale | Standard Deviation 12.1 |
Other Pre-specified
SF-36 QoL Scores
The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
Time frame: 6 months
Population: All available data has been reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MitraClip System | SF-36 QoL Scores | SF-36 PCS | 39.0 SF-36 scores on a points scale | Standard Deviation 10.3 |
| MitraClip System | SF-36 QoL Scores | SF-36 MCS | 52.1 SF-36 scores on a points scale | Standard Deviation 10.3 |
| Control Group | SF-36 QoL Scores | SF-36 PCS | 34.2 SF-36 scores on a points scale | Standard Deviation 9.9 |
| Control Group | SF-36 QoL Scores | SF-36 MCS | 47.0 SF-36 scores on a points scale | Standard Deviation 12.9 |
Other Pre-specified
Six-Minute Walk Test Distance (6MWD)
Six-Minute Walk Test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk test distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
Time frame: Baseline
Population: All available 6MWD has been reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Six-Minute Walk Test Distance (6MWD) | 249.6 meters | Standard Deviation 123.8 |
| Control Group | Six-Minute Walk Test Distance (6MWD) | 234.5 meters | Standard Deviation 123.5 |
Other Pre-specified
Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Time frame: Baseline
Population: All available echocardiogram data has been reported.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Present | 1 Participants |
| MitraClip System | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Absent | 299 Participants |
| Control Group | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Present | 1 Participants |
| Control Group | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Absent | 309 Participants |
Other Pre-specified
Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Time frame: At discharge (or 30 days if discharge echocardiogram is not available)
Population: All available echocardiogram data has been reported.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Present | 1 Participants |
| MitraClip System | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Absent | 288 Participants |
| Control Group | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Present | 1 Participants |
| Control Group | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Absent | 257 Participants |
Other Pre-specified
Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Time frame: 12 months
Population: All available echocardiogram has been reported.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Present | 0 Participants |
| MitraClip System | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Absent | 210 Participants |
| Control Group | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Present | 0 Participants |
| Control Group | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Absent | 177 Participants |
Other Pre-specified
Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Time frame: 24 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Present | 0 Participants |
| MitraClip System | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Absent | 164 Participants |
| Control Group | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Present | 0 Participants |
| Control Group | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Absent | 126 Participants |
Other Pre-specified
Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Time frame: 3 years
Population: All available data has been reported.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Present | 0 Participants |
| MitraClip System | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Absent | 120 Participants |
| Control Group | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Present | 0 Participants |
| Control Group | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Absent | 78 Participants |
Other Pre-specified
Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Time frame: 4 years
Population: All electrocardiogram data has been presented.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Present | 0 Participants |
| MitraClip System | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Absent | 81 Participants |
| Control Group | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Present | 0 Participants |
| Control Group | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Absent | 50 Participants |
Other Pre-specified
Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Time frame: 5 years
Population: All available electrocardiogram data has been presented.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Present | 0 Participants |
| MitraClip System | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Absent | 58 Participants |
| Control Group | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Present | 0 Participants |
| Control Group | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Absent | 46 Participants |
Other Pre-specified
Systolic Anterior Motion of the Mitral Valve (Present or Absent)
Time frame: 6 months
Population: All available echocardiogram data has been reported.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Present | 0 Participants |
| MitraClip System | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Absent | 239 Participants |
| Control Group | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Present | 1 Participants |
| Control Group | Systolic Anterior Motion of the Mitral Valve (Present or Absent) | Absent | 218 Participants |
Other Pre-specified
The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline
Time frame: Between baseline and 5 years
Population: All available data has been reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Aldosterone Antagonist | 27 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | ACE Inhibitors | 25 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | ARBs | 28 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Beta Blocker | 40 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Vasodilators Nitrate | 9 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Vasodilators | 6 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Vasodilators Nitrate | 8 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Beta Blocker | 33 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | ACE Inhibitors | 18 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Vasodilators | 13 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | ARBs | 23 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Aldosterone Antagonist | 15 Participants |
Other Pre-specified
The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline
Time frame: Between baseline and 3 years
Population: Not all subjects were on all the drugs.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | ACE-Inhibitors | 44 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Angiotensin-ReceptorBlockers (ARBs) | 40 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | AldosteroneAntagonists | 33 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Beta Blockers | 52 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Vasodilators (Nitrate) | 20 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Vasodilators(Hydralazine) | 17 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Vasodilators (Nitrate) | 9 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | ACE-Inhibitors | 25 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Beta Blockers | 44 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Angiotensin-ReceptorBlockers (ARBs) | 26 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Vasodilators(Hydralazine) | 12 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | AldosteroneAntagonists | 32 Participants |
Other Pre-specified
The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline
Time frame: Between baseline and 4 years
Population: All available data has been reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | ACE Inhibitors | 31 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | ARBS | 39 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Aldosterone Antagonist | 29 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Beta Blocker | 50 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Vasodilators Nitrate | 13 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Vasodilators | 10 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Vasodilators Nitrate | 12 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | ACE Inhibitors | 21 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Beta Blocker | 35 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | ARBS | 27 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Vasodilators | 12 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT and GDMT Dosage From Baseline | Aldosterone Antagonist | 31 Participants |
Other Pre-specified
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose
Time frame: Between baseline and 5 years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE-Inhibitors Decrease > 50% orStop | 20 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone AntagonistsIncrease>100% or New Class | 33 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine)Increase>100%orNew Class | 22 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Increase > 100% orNew Class | 62 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE Inhibitors Increase > 100% orNew Class | 18 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARBs Decrease > 50% or Stop | 5 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARBs Increase > 100% or NewClass | 26 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists Decrease> 50% or Stop | 4 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers Decrease > 50% orStop | 30 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers Increase > 100% orNew Class | 35 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Nitrate) Decrease >50% or Stop | 0 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Nitrate) Increase >100% or New Class | 9 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine)Decrease> 50% or Stop | 8 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Decrease > 50% orStop | 1 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Nitrate) Decrease >50% or Stop | 1 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE-Inhibitors Decrease > 50% orStop | 7 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists Decrease> 50% or Stop | 5 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone AntagonistsIncrease>100% or New Class | 16 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine)Decrease> 50% or Stop | 3 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine)Increase>100%orNew Class | 27 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Decrease > 50% orStop | 0 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers Decrease > 50% orStop | 34 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Nitrate) Increase >100% or New Class | 15 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE Inhibitors Increase > 100% orNew Class | 14 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers Increase > 100% orNew Class | 27 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARBs Decrease > 50% or Stop | 3 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Increase > 100% orNew Class | 34 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARBs Increase > 100% or NewClass | 22 Participants |
Other Pre-specified
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose
Time frame: Between baseline and 4 years
Population: All available data has been reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone AntagonistsIncrease>100% or New Class | 32 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers Decrease > 50% orStop | 29 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers Increase > 100% orNew Class | 35 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Nitrate) Decrease >50% or Stop | 0 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Nitrate) Increase >100% or New Class | 7 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine)Increase>100%orNew Class | 21 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Decrease > 50% orStop | 0 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Increase > 100% orNew Class | 57 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE-Inhibitors Decrease > 50% orStop | 20 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE Inhibitors Increase > 100% orNew Class | 18 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARBs Decrease > 50% or Stop | 5 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARBs Increase > 100% or NewClass | 25 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists Decrease> 50% or Stop | 3 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine)Decrease> 50% or Stop | 7 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Decrease > 50% orStop | 0 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone AntagonistsIncrease>100% or New Class | 15 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARBs Increase > 100% or NewClass | 21 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers Decrease > 50% orStop | 32 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Increase > 100% orNew Class | 33 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers Increase > 100% orNew Class | 26 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARBs Decrease > 50% or Stop | 3 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Nitrate) Decrease >50% or Stop | 1 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE-Inhibitors Decrease > 50% orStop | 7 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Nitrate) Increase >100% or New Class | 14 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine)Decrease> 50% or Stop | 3 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists Decrease> 50% or Stop | 5 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine)Increase>100%orNew Class | 26 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE Inhibitors Increase > 100% orNew Class | 12 Participants |
Other Pre-specified
The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose
Time frame: Between baseline and 3 years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Nitrate) Decrease >50% or Stop | 0 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers Decrease > 50% orStop | 25 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE Inhibitors Increase > 100% orNew Class | 15 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers Increase > 100% orNew Class | 32 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Nitrate) Increase >100% or New Class | 6 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE-Inhibitors Decrease > 50% orStop | 19 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine)Decrease> 50% or Stop | 7 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARBs Increase > 100% or NewClass | 22 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine)Increase>100%orNew Class | 19 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists Decrease> 50% or Stop | 3 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Decrease > 50% orStop | 0 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARBs Decrease > 50% or Stop | 4 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Increase > 100% orNew Class | 45 Participants |
| MitraClip System | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone AntagonistsIncrease>100% or New Class | 27 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Increase > 100% orNew Class | 29 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE Inhibitors Increase > 100% orNew Class | 12 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARBs Decrease > 50% or Stop | 3 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers Increase > 100% orNew Class | 26 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Nitrate) Decrease >50% or Stop | 1 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARBs Increase > 100% or NewClass | 19 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists Decrease> 50% or Stop | 5 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone AntagonistsIncrease>100% or New Class | 14 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers Decrease > 50% orStop | 29 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Nitrate) Increase >100% or New Class | 13 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine)Decrease> 50% or Stop | 1 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine)Increase>100%orNew Class | 24 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Decrease > 50% orStop | 0 Participants |
| Control Group | The Number and Reasons for Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE-Inhibitors Decrease > 50% orStop | 7 Participants |
Other Pre-specified
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose
Time frame: Between baseline and 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARBs Decrease >50% or Stop | 3 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers Decrease > 50% or Stop | 16 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Nitrate) Increase > 100% or New Class | 3 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers Increase > 100% or New Class | 26 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARBs Increase > 100% or New Class | 13 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Nitrate) Decrease > 50% or Stop | 0 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine) Decrease > 50% or Stop | 3 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE-Inhibitors Increase > 100% or New Class | 9 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine) Increase>100%orNewClass | 13 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists Decrease > 50% or Stop | 2 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Decrease > 50% or Stop | 0 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE-Inhibitors Decrease > 50% or Stop | 13 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN inhibitors Increase > 100% or New Class | 13 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists Increase>100% or New Class | 16 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN inhibitors Increase > 100% or New Class | 20 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Nitrate) Increase > 100% or New Class | 6 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE-Inhibitors Decrease > 50% or Stop | 5 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE-Inhibitors Increase > 100% or New Class | 8 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARBs Decrease >50% or Stop | 2 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARBs Increase > 100% or New Class | 12 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists Decrease > 50% or Stop | 2 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists Increase>100% or New Class | 8 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers Decrease > 50% or Stop | 16 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers Increase > 100% or New Class | 12 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine) Decrease > 50% or Stop | 0 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine) Increase>100%orNewClass | 12 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Decrease > 50% or Stop | 0 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Nitrate) Decrease > 50% or Stop | 0 Participants |
Other Pre-specified
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose
Time frame: Between baseline and 24 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARBs Increase > 100% or New Class | 19 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Increase > 100% or New Class | 26 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE-Inhibitors Decrease > 50% or Stop | 17 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE Inhibitors Increase > 100% or New Class | 14 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARBs Decrease > 50% or Stop | 3 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists Decrease > 50% or Stop | 2 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists Increase>100% or New Class | 21 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers Decrease > 50% or Stop | 20 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers Increase > 100% or New Class | 29 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Nitrate) Decrease > 50% or Stop | 0 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Nitrate) Increase > 100% or New Class | 5 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine)Decrease > 50% or Stop | 6 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine) Increase>100%orNew Class | 14 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Decrease > 50% or Stop | 0 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Nitrate) Increase > 100% or New Class | 11 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers Decrease > 50% or Stop | 26 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Increase > 100% or New Class | 24 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine) Increase>100%orNew Class | 20 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE-Inhibitors Decrease > 50% or Stop | 6 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers Increase > 100% or New Class | 19 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE Inhibitors Increase > 100% or New Class | 11 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine)Decrease > 50% or Stop | 1 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARBs Decrease > 50% or Stop | 2 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARBs Increase > 100% or New Class | 16 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Nitrate) Decrease > 50% or Stop | 1 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists Decrease > 50% or Stop | 3 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Decrease > 50% or Stop | 0 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists Increase>100% or New Class | 10 Participants |
Other Pre-specified
The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose
Time frame: Between baseline and 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARB (Increase > 100% or New Class) | 7 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists (Decrease > 50% or Stop) | 1 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists (Increase > 100% or NewCl) | 11 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers (Decrease > 50% or Stop) | 14 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers (Increase > 100% or New Class) | 19 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators (Nitrate) Decrease > 50% or Stop | 0 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators (Nitrate) Increase > 100% or NewClass | 1 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators (Hydralazine) Decrease > 50% or Stop | 1 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine)Increase>100% orNewClass | 7 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Decrease > 50% or Stop | 0 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE-I (Decrease > 50% or Stop) | 8 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE-I (Increase > 100% or New Class) | 6 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARB (Decrease > 50% or Stop) | 2 Participants |
| MitraClip System | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Increase > 100% or New Class | 6 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE-I (Decrease > 50% or Stop) | 4 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARB (Increase > 100% or New Class) | 9 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators (Hydralazine) Decrease > 50% or Stop | 0 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists (Decrease > 50% or Stop) | 1 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARB (Decrease > 50% or Stop) | 1 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists (Increase > 100% or NewCl) | 7 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine)Increase>100% orNewClass | 6 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers (Decrease > 50% or Stop) | 10 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE-I (Increase > 100% or New Class) | 4 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers (Increase > 100% or New Class) | 9 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Decrease > 50% or Stop | 0 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators (Nitrate) Decrease > 50% or Stop | 0 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors Increase > 100% or New Class | 12 Participants |
| Control Group | The Number of Subjects With Any Changes in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators (Nitrate) Increase > 100% or NewClass | 5 Participants |
Other Pre-specified
The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose
Time frame: Between baseline and 30 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists (Increase>100%orNewClass) | 2 Participants |
| MitraClip System | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers (Increase >100% or New Class) | 2 Participants |
| MitraClip System | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators (Nitrate) Decrease>50% or Stop | 0 Participants |
| MitraClip System | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARB (Decrease > 50% or Stop) | 1 Participants |
| MitraClip System | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators (Nitrate) Increase > 100% or NewClass | 1 Participants |
| MitraClip System | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE-Inhibitors (Decrease > 50% or Stop) | 0 Participants |
| MitraClip System | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators (Hydralazine) Decrease>50% or Stop | 0 Participants |
| MitraClip System | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARB (Increase > 100% or New Class) | 0 Participants |
| MitraClip System | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine)Increase >100% orNewClass | 1 Participants |
| MitraClip System | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers (Decrease > 50% or Stop) | 2 Participants |
| MitraClip System | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors - Decrease>50% or Stop | 0 Participants |
| MitraClip System | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists (Decrease > 50% or stop) | 0 Participants |
| MitraClip System | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors - Increase > 100% or NewClass | 0 Participants |
| MitraClip System | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE-Inhibitors (Increase > 100% or New Class) | 1 Participants |
| Control Group | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors - Increase > 100% or NewClass | 0 Participants |
| Control Group | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers (Decrease > 50% or Stop) | 0 Participants |
| Control Group | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE-Inhibitors (Decrease > 50% or Stop) | 0 Participants |
| Control Group | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ACE-Inhibitors (Increase > 100% or New Class) | 1 Participants |
| Control Group | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARB (Decrease > 50% or Stop) | 0 Participants |
| Control Group | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARB (Increase > 100% or New Class) | 1 Participants |
| Control Group | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists (Decrease > 50% or stop) | 0 Participants |
| Control Group | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Beta Blockers (Increase >100% or New Class) | 2 Participants |
| Control Group | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators (Nitrate) Decrease>50% or Stop | 0 Participants |
| Control Group | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators (Nitrate) Increase > 100% or NewClass | 0 Participants |
| Control Group | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators (Hydralazine) Decrease>50% or Stop | 0 Participants |
| Control Group | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Vasodilators(Hydralazine)Increase >100% orNewClass | 1 Participants |
| Control Group | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | ARN Inhibitors - Decrease>50% or Stop | 0 Participants |
| Control Group | The Number of Subjects With Change in GDMT From Baseline That Result in a Greater Than 100% Increase or Greater Than 50% Decrease in Dose | Aldosterone Antagonists (Increase>100%orNewClass) | 2 Participants |
Other Pre-specified
The Number of Subjects With Changes in GDMT Dosage From Baseline
Time frame: Between baseline and 30 days
Population: Not all subjects were on all the drugs.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline | Angiotensin-Receptor Blocker (ARBs) | 20 Participants |
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline | ACE-Inhibitors | 44 Participants |
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline | Vasodilators (Nitrate) | 10 Participants |
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline | Aldosterone Antagonists | 29 Participants |
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline | Vasodilators (Hydralazine) | 11 Participants |
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline | Beta Blocker | 60 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline | Vasodilators (Hydralazine) | 13 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline | ACE-Inhibitors | 23 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline | Angiotensin-Receptor Blocker (ARBs) | 20 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline | Aldosterone Antagonists | 25 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline | Beta Blocker | 48 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline | Vasodilators (Nitrate) | 12 Participants |
Other Pre-specified
The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months
Time frame: Between baseline and 12 months
Population: Not all subjects were on all the drugs.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months | ACE-Inhibitors | 61 Participants |
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months | Angiotension-Receptor Blockers (ARBs) | 14 Participants |
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months | Aldosterone Antagonists | 44 Participants |
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months | Beta Blocker | 76 Participants |
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months | Vasodilators (Nitrate) | 14 Participants |
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months | Vasodilators (Hydralazine) | 14 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months | Vasodilators (Nitrate) | 19 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months | ACE-Inhibitors | 37 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months | Beta Blocker | 66 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months | Angiotension-Receptor Blockers (ARBs) | 38 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months | Vasodilators (Hydralazine) | 14 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline and 12 Months | Aldosterone Antagonists | 44 Participants |
Other Pre-specified
The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months
Time frame: Between baseline and 24 months
Population: Not all subjects were on all the drugs.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months | ACE-Inhibitors | 36 Participants |
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months | Angiotensin-Receptor Blockers (ARBs) | 29 Participants |
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months | Aldosterone Antagonists | 28 Participants |
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months | Beta Blockers | 43 Participants |
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months | Vasodilators (Nitrate) | 7 Participants |
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months | Vasodilators (Hydralazine) | 10 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months | Vasodilators (Nitrate) | 11 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months | ACE-Inhibitors | 24 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months | Beta Blockers | 34 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months | Angiotensin-Receptor Blockers (ARBs) | 21 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months | Vasodilators (Hydralazine) | 14 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline and 24 Months | Aldosterone Antagonists | 21 Participants |
Other Pre-specified
The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months
Time frame: Between baseline and 6 months
Population: Not all subjects were on all the drugs.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months | Angiotensin-Receptor Blockers (ARBs) | 35 Participants |
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months | Beta Blocker | 74 Participants |
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months | ACE-Inhibitors | 53 Participants |
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months | Vasodilators (Nitrate) | 14 Participants |
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months | Aldosterone Antagonists | 44 Participants |
| MitraClip System | The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months | Vasodilators (Hydralazine) | 15 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months | Aldosterone Antagonists | 35 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months | ACE-Inhibitors | 41 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months | Angiotensin-Receptor Blockers (ARBs) | 27 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months | Vasodilators (Hydralazine) | 20 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months | Beta Blocker | 60 Participants |
| Control Group | The Number of Subjects With Changes in GDMT Dosage From Baseline to 6 Months | Vasodilators (Nitrate) | 18 Participants |
Other Pre-specified
Total Procedure Time
Defined as the time elapsed from the first of any of the following: intravascular catheter placement, anesthesia or sedation, or transesophageal echocardiogram (TEE), to the removal of the last catheter and TEE
Time frame: Day 0
Population: Total procedure time was available for 293 subjects from the 302 subjects randomized to device arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MitraClip System | Total Procedure Time | 162.9 minutes | Standard Deviation 118.1 |