Mitral Insufficiency, Mitral Regurgitation, Mitral Valve Incompetence, Mitral Valve Insufficiency, Mitral Valve Regurgitation
Conditions
Keywords
Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation, Mitral Insufficiency, Mitral Valve, Mitral Regurgitation (MR), Mitral Valve Prolapse, Edge to Edge (E2E), Alfieri Technique, MitraClip, Functional MR, Degenerative MR, Echocardiogram, Coronary Artery Disease (CAD), Heart Failure, Heart Attack, EVEREST, EVEREST I, EVEREST II, REALISM
Brief summary
Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6-month, 12-month, 36-month and 60-month clinical follow-up. The study consists of two arms: a High Risk group (NCT01940120) and a Non-High Risk group (NCT00209274) . Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU).
Detailed description
The EVEREST II REALISM study (REALISM study) is a continued access registry designed for continued data collection on the use of Abbott Vascular's MitraClip System (MitraClip® Device) under more real world conditions. After the completion of enrollment in the pivotal EVEREST II Randomized Controlled Trial (RCT) NCT00209274 and EVEREST II High Risk Registry Study NCT01940120, continued access to the technology was warranted to collect additional safety and effectiveness data on the MitraClip® Device. This continued access study was approved by FDA on November 21, 2008 (G030064). There are two arms (High Risk and Non-High Risk) in the REALISM study. Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). Enrollment in the Non-High Risk arm of the study concluded on April 14, 2011 and enrollment in the High Risk arm concluded on December 19, 2013. REALISM is a prospective, multi-center, study of the safety and effectiveness of an endovascular approach to the treatment of mitral valve regurgitation using the Evalve Cardiovascular Valve Repair System (MitraClip® implant). Patients with moderate-to-severe (3+) or severe (4+) mitral regurgitation (MR), as determined by the site from a transthoracic echocardiogram (TTE), were considered for enrollment in this study. The TTE and a transesophageal echocardiogram (TEE) are used to assess eligibility criteria for MR severity, valve anatomy and left ventricular parameters.
Interventions
DEVICEMitraClip® implant
Percutaneous mitral valve repair using MitraClip implant
Sponsors
Abbott Medical Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients screened in EVEREST II REALISM Study will first be screened for high risk (HR) status and enrolled into the HR arm if they meet eligibility for this arm of the study. If they do not meet eligibility for the HR arm, patients will be further screened for eligibility for enrollment into the non-high risk (NHR) arm. Key Inclusion Criteria: * The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the mitral valve (MV) * Male or non-pregnant female * Trans-septal catheterization is determined to be feasible by the treating physician High Risk Arm: * Predicted procedural mortality risk calculated using the STS surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a HR surgical candidate due to the presence of one of the following indications: 1. Porcelain aorta or mobile ascending aortic atheroma 2. Post-radiation mediastinum 3. Previous mediastinitis 4. Functional MR with EF \<40 5. Over 75 years old with EF\<40 6. Re-operation with patent grafts 7. Two or more prior chest surgeries 8. Hepatic cirrhosis 9. Three or more of the following STS high risk factors 9.1 Creatinine \>2.5 mg/dL 9.2 Prior chest surgery 9.3 Age over 75 9.4 EF\<35 * Symptomatic moderate to severe (3+) or severe (4+) chronic MR and in the judgment of the investigator intervention to reduce MR is likely to provide symptomatic relief for the patient * American Society of Anesthesiologists (ASA) physical status classification of ASA IV or lower Non-High Risk Arm: * Moderate to severe (3+) or severe (4+) chronic MV regurgitation and: 1\. Symptomatic with \>25% LVEF and LVESD ≤55mm or, 2. Asymptomatic with one or more of the following: i. Left Ventricular Ejection Fraction (LVEF) 25% to 60% ii. Left Ventricular End-Systolic Diameter (LVESD) ≥40 mm iii. New onset of Atrial fibrillation (AFib) iv. Pulmonary arterial systolic pressure (PASP) \>50 mmHg at rest or \>60 mmHg with exercise * Candidate for MV repair or replacement surgery, including cardiopulmonary bypass Key
Exclusion criteria
* Evidence of an Acute Myocardial Infarction (AMI) in the prior 12 weeks of the intended treatment * In the judgment of the Investigator, the femoral vein cannot accommodate a 24 French scale (F) catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral Deep Venous Thrombus (DVT) is present * MV orifice area \<4.0 cm2 * If leaflet flail is present: 1. Flail Width ≥15 mm, or 2. Flail Gap ≥10 mm. * If leaflet tethering is present: 1\. Vertical coaptation length \<2 mm * Leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in MR. This may include: 1. Evidence of calcification in the grasping area of the A2 and/or P2 scallops 2. Presence of a significant cleft of A2 or P2 scallops 3. More than one anatomic criteria dimensionally near the exclusion limits 4. Bileaflet flail or severe bileaflet prolapse 5. Lack of both primary and secondary chordal support * Hemodynamic instability (systolic pressure \<90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump). * Need for emergency surgery for any reason * Prior MV surgery or valvuloplasty or any currently implanted mechanical prosthetic valve or currently implanted Ventricular assist device (VAD) * Echocardiographic evidence of intracardiac mass, thrombus or vegetation * Active endocarditis or active rheumatic heart disease or leaflets degenerated from either endocarditis or rheumatic disease (i.e. noncompliant, perforated) * History of bleeding diathesis or coagulopathy or subject will refuse blood transfusions * Life expectancy \<12 months * Active infections requiring current antibiotic therapy * Patients in whom transesophageal echocardiography (TEE) is contraindicated High Risk Arm: * EF \<20%, and/or LVESD \>60 mm Non-High Risk Arm: * The need for any other cardiac surgery * Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure * Severe Left Ventricular (LV) dysfunction (EF \<25% and/or LVESD \>55mm) * Severe mitral annular calcification * Systolic anterior motion of the MV leaflet * Hypertrophic cardiomyopathy * History of a stroke or documented Transient Ischemic Attack (TIA) within the prior 6 months * Upper GI bleeding within the prior 6 months * Platelet count \<75,000 cells/mm³ * Creatinine \>2.5mg/dL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 12-Month Efficacy | 12 months | Defined as freedom from: Surgery for Mitral Regurgitation (MR) or Valve Dysfunction, death, and MR \> 2+ (moderate to severe (3+) or severe MR (4+)). |
| Number of Participants With Major Adverse Events | 30 days | A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastro-intestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Atrial Septal Defect (ASD) | 30 days | Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD. |
| Number of Participants With Major Adverse Events (MAE) in Patients Over 75 Years of Age | 30 days | MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age. |
| Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | 12 Months | MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age. |
| Number of Participants With Acute Procedural Success | At discharge (an average of ≤ 12.3 days post-index procedure) | Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ or less as determined by the echocardiographic assessment at discharge. The 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or uninterpretable, providing the patient has not undergone subsequent surgery after attempted clip. |
| Number of Participants With Procedural Success | 30 days | Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA at 30 days. |
| Number of Participants With Clinical Durability | 12 months | Defined as the proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that at 12 months have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA at 12 months. |
| Number of Participants With Clip Implant Rate | On the day of index procedure (≤1 day) | Defined as the procedural rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter. |
| Procedure Time | On the day of index procedure | The mean procedure time is defined as the start time of the transseptal procedure to the time the steerable guide catheter (SGC) is removed. |
| Device Time | On the day of index procedure | Device time is defined as the time of insertion of the Steerable Guide Catheter (SGC) to the time the MitraClip delivery catheter is retracted into the SGC. |
| Fluoroscopy Duration | On the day of index procedure | Mean fluoroscopy duration during the MitraClip procedure. |
| Number of Participants With MitraClip Devices Implanted | On the day of index procedure | The distribution of number of MitraClip devices implanted in patients. |
| Post-Procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU)/ Post-anesthesia Care Unit (PACU) Duration | At discharge (an average of ≤ 12.3 days post-index procedure). | Defined as the number of hours for which patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit. |
| Post-Procedure Length of Hospital Stay | At discharge (an average of ≤ 12.3 days post-index procedure). | Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility. |
| Number of Participants Experiencing Death | 12 months visit window (410 days) | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Non-cardiac death is defined as a death not due to cardiac causes (as defined above). |
| Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | At discharge (an average of ≤ 12.3 days post-index procedure) | — |
| Number of Participants With Serious Adverse Events | 30 days | The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization. |
| Left Ventricular Ejection Fraction (LVEF) | At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days | Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to discharge or 30 days as determined by echo core laboratory. |
| Septal-Lateral Annular Dimension Diastole (SLADd) | At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days | Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to discharge or 30 days as determined by echo core laboratory. |
| Septal-Lateral Annular Dimension Systole (SLADs) | At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days | Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to discharge or 30 days as determined by echo core laboratory. |
| Number of Participants With Hospital Re-admissions | 30 days | Defined as re-admission of patients to the hospital following discharge from the Clip procedure. |
| Number of Participants With Device Embolization or Single Leaflet Device Attachment (SLDA) | 0 to 5 years | A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. |
| Number of Participants With Mitral Stenosis | 0 to 5 years | Mitral stenosis is a key safety consideration assessed after implantation of the MitraClip device. It is defined as Mitral Valve Area (MVA) less than 1.5 cm\^2 as assessed by the Echocardiography Core Laboratory (ECL). |
| Number of Participants With Mitral Regurgitation (MR) Severity | 30 days(Follow-up) | Paired site-assessed Mitral regurgitation severity between baseline and 30 days using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe. |
| Number of Participants With MR Severity | 12 months | Paired site-assessed Mitral regurgitation severity between baseline and 12 months using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe. |
| Number of Participants With Second Intervention to Place an Additional Mitraclip Device. | 139 days post the index procedure | If residual MR was determined to be clinically unacceptable for patients who received only 1 clip during the index procedure, a second intervention to place an additional MitraClip device could be considered. |
| Number of Participants With New York Heart Association (NYHA) Functional Class | 30 days | Paired NYHA data from baseline to 30 days. 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. They 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. |
| Number of Participants With NYHA Functional Class | 12 months | Paired NYHA data from baseline to 12 months. 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. They 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. |
| Left Ventricular End-diastolic Volume (LVEDV) | At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days | Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to discharge or 30 days as determined by echo core laboratory. |
| Left Ventricular End-systolic Volume (LVESV) | At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days | Paired Left ventricular end-systolic volume (LVESV) data from baseline to discharge or 30 days as determined by echo core laboratory. |
| Left Ventricular Internal Dimension Diastole (LVIDd) | At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days | Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to discharge or 30 days as determined by echo core laboratory. |
| Left Ventricular Internal Dimension Systole (LVIDs) | At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days | Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to discharge or 30 days as determined by echo core laboratory. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 30 Days | 30 days | The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts: * Physical functioning * Role limitations due to physical or * Emotional health * Bodily pain * General health perceptions * Vitality * Social functioning * General mental health Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health. The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively. |
| 36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 12 Months | 12 months | The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts: * Physical functioning * Role limitations due to physical or * Emotional health * Bodily pain * General health perceptions * Vitality * Social functioning * General mental health Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health. The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively. |
| Change in 6-Minute Walk Test (6MWT) | At Baseline and 30 Days | Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes. |
Countries
United States
Participant flow
Recruitment details
As of February 13, 2018, a total of 59 Compassionate Use and 7 Emergency Use patients have undergone MitraClip procedure between 14 Dec 2010 and 22 Feb 2013. A total of 628 patients in the High Risk arm between January 22, 2009 and December 19, 2013 and 271 patients in the Non-High Risk arm were enrolled between January 22, 2009 and April 14, 2011.
Pre-assignment details
Patients who did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either EU or CU.
Participants by arm
| Arm | Count |
|---|---|
| Compassionate Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | 59 |
| Emergency Use Patients that did not meet REALISM High Risk or Non-High Risk eligibility criteria were evaluated for consideration for either Emergency Use (EU) or Compassionate Use (CU). The objective of the Compassionate and Emergency Use Group of the EVEREST II REALISM study is to provide access to the MitraClip Device, in a non-commercial setting, for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. All EU patients had a medical condition that in the opinion of the investigators was likely to result in death within 30 days. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | 7 |
| High Risk Includes patients with a predicted procedural mortality risk calculated using the Society For Thoracic Surgeon (STS) surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a high risk surgical candidate due to the presence of pre-defined risk factors. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | 628 |
| Non-high Risk Includes patients who are candidate for mitral valve repair or replacement surgery, including cardiopulmonary bypass (i.e. non-high risk).
If a patient was not a candidate for the high risk arm, but met all other eligibility criteria for the non-high risk arm, the patient was enrolled into the non-high risk arm of EVEREST II REALISM.
The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip® implant. | 271 |
| Total | 965 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 42 | 7 | 379 | 96 |
| Overall Study | Expected | 2 | 0 | 6 | 0 |
| Overall Study | Lost to Follow-up | 2 | 0 | 11 | 7 |
| Overall Study | Not due | 0 | 0 | 21 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 0 | 70 | 30 |
Baseline characteristics
| Characteristic | Compassionate Use | Emergency Use | High Risk | Non-high Risk | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 51 Participants | 6 Participants | 553 Participants | 230 Participants | 840 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 1 Participants | 75 Participants | 41 Participants | 125 Participants |
| Age, Continuous | 75.2 years STANDARD_DEVIATION 9.2 | 78.6 years STANDARD_DEVIATION 11.1 | 76.7 years STANDARD_DEVIATION 10.7 | 73.9 years STANDARD_DEVIATION 11.2 | 75.5 years STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 34 Participants | 9 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 7 Participants | 594 Participants | 262 Participants | 919 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 8 Participants | 6 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 47 Participants | 12 Participants | 63 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 9 Participants | 6 Participants | 16 Participants |
| Race (NIH/OMB) White | 54 Participants | 6 Participants | 563 Participants | 246 Participants | 869 Participants |
| Region of Enrollment United States | 59 participants | 7 participants | 628 participants | 271 participants | 66 participants |
| Sex: Female, Male Female | 17 Participants | 3 Participants | 253 Participants | 127 Participants | 400 Participants |
| Sex: Female, Male Male | 42 Participants | 4 Participants | 375 Participants | 144 Participants | 565 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 42 / 59 | 7 / 7 | 379 / 628 | 96 / 271 |
| other Total, other adverse events | 39 / 59 | 4 / 7 | 503 / 628 | 225 / 271 |
| serious Total, serious adverse events | 49 / 59 | 7 / 7 | 542 / 628 | 208 / 271 |
Outcome results
Primary
Number of Participants With 12-Month Efficacy
Defined as freedom from: Surgery for Mitral Regurgitation (MR) or Valve Dysfunction, death, and MR \> 2+ (moderate to severe (3+) or severe MR (4+)).
Time frame: 12 months
Population: Analysis was performed in 52 participants out of 59 in CU arm, in 6 subjects out of 7 in EU arm, in 556 participants out of 628 participants and 248 out of 271 participants in non-HR arm were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassionate Use | Number of Participants With 12-Month Efficacy | 25 Participants |
| Emergency Use | Number of Participants With 12-Month Efficacy | 1 Participants |
| High Risk | Number of Participants With 12-Month Efficacy | 339 Participants |
| Non-high RIsk | Number of Participants With 12-Month Efficacy | 166 Participants |
Primary
Number of Participants With Major Adverse Events
A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastro-intestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.
Time frame: 30 days
Population: Intent-To-Treat Population set (ITT)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassionate Use | Number of Participants With Major Adverse Events | 5 Participants |
| Emergency Use | Number of Participants With Major Adverse Events | 3 Participants |
| High Risk | Number of Participants With Major Adverse Events | 98 Participants |
| Non-high RIsk | Number of Participants With Major Adverse Events | 31 Participants |
Primary
Number of Participants With Major Adverse Events
A combined clinical endpoint of death, myocardial infarction (MI), re-operation for failed surgical repair or replacement, non-elective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia and transfusion of 2 or more units of blood.
Time frame: 12 months
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassionate Use | Number of Participants With Major Adverse Events | 31 Participants |
| Emergency Use | Number of Participants With Major Adverse Events | 5 Participants |
| High Risk | Number of Participants With Major Adverse Events | 223 Participants |
| Non-high RIsk | Number of Participants With Major Adverse Events | 74 Participants |
Secondary
Device Time
Device time is defined as the time of insertion of the Steerable Guide Catheter (SGC) to the time the MitraClip delivery catheter is retracted into the SGC.
Time frame: On the day of index procedure
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Device Time | 115.1 minutes | Standard Deviation 65.6 |
| Emergency Use | Device Time | 96.6 minutes | Standard Deviation 60.2 |
| High Risk | Device Time | 106.8 minutes | Standard Deviation 58.2 |
| Non-high RIsk | Device Time | 111.5 minutes | Standard Deviation 63.8 |
Secondary
Fluoroscopy Duration
Mean fluoroscopy duration during the MitraClip procedure.
Time frame: On the day of index procedure
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Fluoroscopy Duration | 42.5 minutes | Standard Deviation 28.9 |
| Emergency Use | Fluoroscopy Duration | 33.6 minutes | Standard Deviation 21.3 |
| High Risk | Fluoroscopy Duration | 38.5 minutes | Standard Deviation 24.4 |
| Non-high RIsk | Fluoroscopy Duration | 34.6 minutes | Standard Deviation 20 |
Secondary
Left Ventricular Ejection Fraction (LVEF)
Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to discharge or 30 days as determined by echo core laboratory.
Time frame: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Left Ventricular Ejection Fraction (LVEF) | 46.9 percentage of ejection fraction | Standard Deviation 15.5 |
| Emergency Use | Left Ventricular Ejection Fraction (LVEF) | 59.4 percentage of ejection fraction | Standard Deviation 10.8 |
| High Risk | Left Ventricular Ejection Fraction (LVEF) | 44.7 percentage of ejection fraction | Standard Deviation 13.1 |
| Non-high RIsk | Left Ventricular Ejection Fraction (LVEF) | 53.0 percentage of ejection fraction | Standard Deviation 11.2 |
Secondary
Left Ventricular Ejection Fraction (LVEF)
Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 60 months as determined by echo core laboratory.
Time frame: 60 months
Population: For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Risk | Left Ventricular Ejection Fraction (LVEF) | 46.3 percentage of ejection fraction | Standard Deviation 14.6 |
| Non-high RIsk | Left Ventricular Ejection Fraction (LVEF) | 55.5 percentage of ejection fraction | Standard Deviation 11.4 |
Secondary
Left Ventricular Ejection Fraction (LVEF)
Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 24 months as determined by echo core laboratory.
Time frame: 24 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Left Ventricular Ejection Fraction (LVEF) | 47.0 percentage of ejection fraction | Standard Deviation 13.9 |
| High Risk | Left Ventricular Ejection Fraction (LVEF) | 46.1 percentage of ejection fraction | Standard Deviation 14.2 |
| Non-high RIsk | Left Ventricular Ejection Fraction (LVEF) | 54.4 percentage of ejection fraction | Standard Deviation 11.8 |
Secondary
Left Ventricular Ejection Fraction (LVEF)
Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 36 months as determined by echo core laboratory.
Time frame: 36 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Left Ventricular Ejection Fraction (LVEF) | 41.5 percentage of ejection fraction | Standard Deviation 17.4 |
| High Risk | Left Ventricular Ejection Fraction (LVEF) | 45.9 percentage of ejection fraction | Standard Deviation 15 |
| Non-high RIsk | Left Ventricular Ejection Fraction (LVEF) | 55.5 percentage of ejection fraction | Standard Deviation 12.1 |
Secondary
Left Ventricular Ejection Fraction (LVEF)
Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 48 months as determined by echo core laboratory.
Time frame: 48 months
Population: For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Risk | Left Ventricular Ejection Fraction (LVEF) | 48.9 percentage of ejection fraction | Standard Deviation 14.6 |
| Non-high RIsk | Left Ventricular Ejection Fraction (LVEF) | 58.2 percentage of ejection fraction | Standard Deviation 8.5 |
Secondary
Left Ventricular Ejection Fraction (LVEF)
Paired Left Ventricular Ejection Fraction (LVEF) data from baseline to 12 months as determined by echo core laboratory.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Left Ventricular Ejection Fraction (LVEF) | 46.0 percentage of ejection fraction | Standard Deviation 15.6 |
| High Risk | Left Ventricular Ejection Fraction (LVEF) | 47.2 percentage of ejection fraction | Standard Deviation 14 |
| Non-high RIsk | Left Ventricular Ejection Fraction (LVEF) | 53.9 percentage of ejection fraction | Standard Deviation 11.5 |
Secondary
Left Ventricular End-diastolic Volume (LVEDV)
Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to discharge or 30 days as determined by echo core laboratory.
Time frame: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Left Ventricular End-diastolic Volume (LVEDV) | 163.9 ml | Standard Deviation 68.2 |
| Emergency Use | Left Ventricular End-diastolic Volume (LVEDV) | 110.7 ml | Standard Deviation 25.1 |
| High Risk | Left Ventricular End-diastolic Volume (LVEDV) | 143.1 ml | Standard Deviation 54.1 |
| Non-high RIsk | Left Ventricular End-diastolic Volume (LVEDV) | 121.8 ml | Standard Deviation 43.8 |
Secondary
Left Ventricular End-diastolic Volume (LVEDV)
Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 60 months as determined by echo core laboratory.
Time frame: 60 months
Population: For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Risk | Left Ventricular End-diastolic Volume (LVEDV) | 146.1 ml | Standard Deviation 71.4 |
| Non-high RIsk | Left Ventricular End-diastolic Volume (LVEDV) | 125.9 ml | Standard Deviation 45.6 |
Secondary
Left Ventricular End-diastolic Volume (LVEDV)
Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 48 months as determined by the echo core laboratory.
Time frame: 48 months
Population: For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Risk | Left Ventricular End-diastolic Volume (LVEDV) | 138.6 ml | Standard Deviation 68.2 |
| Non-high RIsk | Left Ventricular End-diastolic Volume (LVEDV) | 128.1 ml | Standard Deviation 38.2 |
Secondary
Left Ventricular End-diastolic Volume (LVEDV)
Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 36 months as determined by echo core laboratory.
Time frame: 36 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Left Ventricular End-diastolic Volume (LVEDV) | 155.7 ml | Standard Deviation 56.9 |
| High Risk | Left Ventricular End-diastolic Volume (LVEDV) | 150.9 ml | Standard Deviation 69 |
| Non-high RIsk | Left Ventricular End-diastolic Volume (LVEDV) | 120.1 ml | Standard Deviation 41 |
Secondary
Left Ventricular End-diastolic Volume (LVEDV)
Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 24 months as determined by echo core laboratory.
Time frame: 24 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Left Ventricular End-diastolic Volume (LVEDV) | 175.0 ml | Standard Deviation 65.4 |
| High Risk | Left Ventricular End-diastolic Volume (LVEDV) | 148.2 ml | Standard Deviation 68.2 |
| Non-high RIsk | Left Ventricular End-diastolic Volume (LVEDV) | 119.6 ml | Standard Deviation 40 |
Secondary
Left Ventricular End-diastolic Volume (LVEDV)
Paired Left ventricular end-diastolic volume (LVEDV) data from baseline to 12 months as determined by echo core laboratory.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Left Ventricular End-diastolic Volume (LVEDV) | 171.1 ml | Standard Deviation 83.4 |
| High Risk | Left Ventricular End-diastolic Volume (LVEDV) | 142.9 ml | Standard Deviation 57.3 |
| Non-high RIsk | Left Ventricular End-diastolic Volume (LVEDV) | 120.9 ml | Standard Deviation 30 |
Secondary
Left Ventricular End-systolic Volume (LVESV)
Paired Left ventricular end-systolic volume (LVESV) data from baseline to 60 months as determined by echo core laboratory.
Time frame: 60 months
Population: For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Risk | Left Ventricular End-systolic Volume (LVESV) | 85.4 ml | Standard Deviation 62.9 |
| Non-high RIsk | Left Ventricular End-systolic Volume (LVESV) | 59.0 ml | Standard Deviation 38.2 |
Secondary
Left Ventricular End-systolic Volume (LVESV)
Paired Left ventricular end-systolic volume (LVESV) data from baseline to discharge or 30 days as determined by echo core laboratory.
Time frame: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Left Ventricular End-systolic Volume (LVESV) | 94.7 ml | Standard Deviation 58.9 |
| Emergency Use | Left Ventricular End-systolic Volume (LVESV) | 46.3 ml | Standard Deviation 21.5 |
| High Risk | Left Ventricular End-systolic Volume (LVESV) | 82.9 ml | Standard Deviation 44.7 |
| Non-high RIsk | Left Ventricular End-systolic Volume (LVESV) | 59.4 ml | Standard Deviation 31.9 |
Secondary
Left Ventricular End-systolic Volume (LVESV)
Paired Left ventricular end-systolic volume (LVESV) data from baseline to 48 months as determined by echo core laboratory.
Time frame: 48 months
Population: For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Risk | Left Ventricular End-systolic Volume (LVESV) | 77.8 ml | Standard Deviation 61.6 |
| Non-high RIsk | Left Ventricular End-systolic Volume (LVESV) | 55.3 ml | Standard Deviation 26.5 |
Secondary
Left Ventricular End-systolic Volume (LVESV)
Paired Left ventricular end-systolic volume (LVESV) data from baseline to 12 months as determined by echo core laboratory.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Left Ventricular End-systolic Volume (LVESV) | 102.2 ml | Standard Deviation 71.8 |
| High Risk | Left Ventricular End-systolic Volume (LVESV) | 80.4 ml | Standard Deviation 48.6 |
| Non-high RIsk | Left Ventricular End-systolic Volume (LVESV) | 57.6 ml | Standard Deviation 29.5 |
Secondary
Left Ventricular End-systolic Volume (LVESV)
Paired Left ventricular end-systolic volume (LVESV) data from baseline to 24 months as determined by echo core laboratory.
Time frame: 24 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Left Ventricular End-systolic Volume (LVESV) | 98.7 ml | Standard Deviation 56 |
| High Risk | Left Ventricular End-systolic Volume (LVESV) | 85.9 ml | Standard Deviation 59 |
| Non-high RIsk | Left Ventricular End-systolic Volume (LVESV) | 57.1 ml | Standard Deviation 32.6 |
Secondary
Left Ventricular End-systolic Volume (LVESV)
Paired Left ventricular end-systolic volume (LVESV) data from baseline to 36 months as determined by echo core laboratory.
Time frame: 36 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Left Ventricular End-systolic Volume (LVESV) | 97.0 ml | Standard Deviation 52.5 |
| High Risk | Left Ventricular End-systolic Volume (LVESV) | 88.8 ml | Standard Deviation 60.2 |
| Non-high RIsk | Left Ventricular End-systolic Volume (LVESV) | 55.8 ml | Standard Deviation 32.2 |
Secondary
Left Ventricular Internal Dimension Diastole (LVIDd)
Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 12 months as determined by echo core laboratory.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.9 cm | Standard Deviation 1.2 |
| High Risk | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.5 cm | Standard Deviation 0.9 |
| Non-high RIsk | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.1 cm | Standard Deviation 0.7 |
Secondary
Left Ventricular Internal Dimension Diastole (LVIDd)
Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 48 months as determined by echo core laboratory.
Time frame: 48 months
Population: For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Risk | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.5 cm | Standard Deviation 1 |
| Non-high RIsk | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.2 cm | Standard Deviation 0.7 |
Secondary
Left Ventricular Internal Dimension Diastole (LVIDd)
Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 36 months as determined by echo core laboratory.
Time frame: 36 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.9 cm | Standard Deviation 0.9 |
| High Risk | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.6 cm | Standard Deviation 1 |
| Non-high RIsk | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.2 cm | Standard Deviation 0.8 |
Secondary
Left Ventricular Internal Dimension Diastole (LVIDd)
Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 60 months as determined by echo core laboratory.
Time frame: 60 months
Population: For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Risk | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.4 cm | Standard Deviation 1 |
| Non-high RIsk | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.3 cm | Standard Deviation 0.8 |
Secondary
Left Ventricular Internal Dimension Diastole (LVIDd)
Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to 24 months as determined by echo core laboratory.
Time frame: 24 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.9 cm | Standard Deviation 1.2 |
| High Risk | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.5 cm | Standard Deviation 1 |
| Non-high RIsk | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.0 cm | Standard Deviation 0.7 |
Secondary
Left Ventricular Internal Dimension Diastole (LVIDd)
Paired Left Ventricular internal dimension diastole (LVIDd) data from baseline to discharge or 30 days as determined by echo core laboratory.
Time frame: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.7 cm | Standard Deviation 1.2 |
| Emergency Use | Left Ventricular Internal Dimension Diastole (LVIDd) | 4.6 cm | Standard Deviation 0.4 |
| High Risk | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.4 cm | Standard Deviation 0.8 |
| Non-high RIsk | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.1 cm | Standard Deviation 0.7 |
Secondary
Left Ventricular Internal Dimension Systole (LVIDs)
Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 24 months as determined by echo core laboratory.
Time frame: 24 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Left Ventricular Internal Dimension Systole (LVIDs) | 4.3 cm | Standard Deviation 1.6 |
| High Risk | Left Ventricular Internal Dimension Systole (LVIDs) | 4.3 cm | Standard Deviation 1.2 |
| Non-high RIsk | Left Ventricular Internal Dimension Systole (LVIDs) | 3.6 cm | Standard Deviation 0.9 |
Secondary
Left Ventricular Internal Dimension Systole (LVIDs)
Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 48 months as determined by echo core laboratory.
Time frame: 48 months
Population: For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Risk | Left Ventricular Internal Dimension Systole (LVIDs) | 4.1 cm | Standard Deviation 1.4 |
| Non-high RIsk | Left Ventricular Internal Dimension Systole (LVIDs) | 3.6 cm | Standard Deviation 0.8 |
Secondary
Left Ventricular Internal Dimension Systole (LVIDs)
Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 60 months as determined by echo core laboratory.
Time frame: 60 months
Population: For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Risk | Left Ventricular Internal Dimension Systole (LVIDs) | 4.2 cm | Standard Deviation 1.3 |
| Non-high RIsk | Left Ventricular Internal Dimension Systole (LVIDs) | 3.7 cm | Standard Deviation 1 |
Secondary
Left Ventricular Internal Dimension Systole (LVIDs)
Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 12 months as determined by echo core laboratory.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Left Ventricular Internal Dimension Systole (LVIDs) | 4.7 cm | Standard Deviation 1.5 |
| High Risk | Left Ventricular Internal Dimension Systole (LVIDs) | 4.2 cm | Standard Deviation 1.1 |
| Non-high RIsk | Left Ventricular Internal Dimension Systole (LVIDs) | 3.6 cm | Standard Deviation 0.9 |
Secondary
Left Ventricular Internal Dimension Systole (LVIDs)
Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to discharge or 30 days as determined by echo core laboratory.
Time frame: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Left Ventricular Internal Dimension Systole (LVIDs) | 4.5 cm | Standard Deviation 1.5 |
| Emergency Use | Left Ventricular Internal Dimension Systole (LVIDs) | 2.9 cm | Standard Deviation 0.5 |
| High Risk | Left Ventricular Internal Dimension Systole (LVIDs) | 4.3 cm | Standard Deviation 1.1 |
| Non-high RIsk | Left Ventricular Internal Dimension Systole (LVIDs) | 3.7 cm | Standard Deviation 0.8 |
Secondary
Left Ventricular Internal Dimension Systole (LVIDs)
Paired Left Ventricular internal dimension systole (LVIDs) data from baseline to 36 months as determined by echo core laboratory.
Time frame: 36 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Left Ventricular Internal Dimension Systole (LVIDs) | 4.7 cm | Standard Deviation 1.3 |
| High Risk | Left Ventricular Internal Dimension Systole (LVIDs) | 4.4 cm | Standard Deviation 1.3 |
| Non-high RIsk | Left Ventricular Internal Dimension Systole (LVIDs) | 3.6 cm | Standard Deviation 1 |
Secondary
Number of Participants Experiencing Death
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Time frame: 12 months visit window (410 days)
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Compassionate Use | Number of Participants Experiencing Death | Cardiac | 13 Participants |
| Compassionate Use | Number of Participants Experiencing Death | Non-Cardiac | 7 Participants |
| Compassionate Use | Number of Participants Experiencing Death | Not Adjudicated | 0 Participants |
| Compassionate Use | Number of Participants Experiencing Death | Not Adjudicable | 1 Participants |
| Emergency Use | Number of Participants Experiencing Death | Non-Cardiac | 3 Participants |
| Emergency Use | Number of Participants Experiencing Death | Not Adjudicated | 0 Participants |
| Emergency Use | Number of Participants Experiencing Death | Not Adjudicable | 0 Participants |
| Emergency Use | Number of Participants Experiencing Death | Cardiac | 2 Participants |
| High Risk | Number of Participants Experiencing Death | Not Adjudicated | 2 Participants |
| High Risk | Number of Participants Experiencing Death | Non-Cardiac | 49 Participants |
| High Risk | Number of Participants Experiencing Death | Not Adjudicable | 0 Participants |
| High Risk | Number of Participants Experiencing Death | Cardiac | 97 Participants |
| Non-high RIsk | Number of Participants Experiencing Death | Not Adjudicable | 0 Participants |
| Non-high RIsk | Number of Participants Experiencing Death | Non-Cardiac | 14 Participants |
| Non-high RIsk | Number of Participants Experiencing Death | Cardiac | 13 Participants |
| Non-high RIsk | Number of Participants Experiencing Death | Not Adjudicated | 0 Participants |
Secondary
Number of Participants With Acute Procedural Success
Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ or less as determined by the echocardiographic assessment at discharge. The 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or uninterpretable, providing the patient has not undergone subsequent surgery after attempted clip.
Time frame: At discharge (an average of ≤ 12.3 days post-index procedure)
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassionate Use | Number of Participants With Acute Procedural Success | 41 Participants |
| Emergency Use | Number of Participants With Acute Procedural Success | 3 Participants |
| High Risk | Number of Participants With Acute Procedural Success | 524 Participants |
| Non-high RIsk | Number of Participants With Acute Procedural Success | 229 Participants |
Secondary
Number of Participants With Clinical Durability
Defined as the proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that at 12 months have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA at 12 months.
Time frame: 12 months
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassionate Use | Number of Participants With Clinical Durability | 22 Participants |
| Emergency Use | Number of Participants With Clinical Durability | 0 Participants |
| High Risk | Number of Participants With Clinical Durability | 325 Participants |
| Non-high RIsk | Number of Participants With Clinical Durability | 163 Participants |
Secondary
Number of Participants With Clinically Significant Atrial Septal Defect (ASD)
Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.
Time frame: 30 days
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassionate Use | Number of Participants With Clinically Significant Atrial Septal Defect (ASD) | 2 Participants |
| Emergency Use | Number of Participants With Clinically Significant Atrial Septal Defect (ASD) | 0 Participants |
| High Risk | Number of Participants With Clinically Significant Atrial Septal Defect (ASD) | 14 Participants |
| Non-high RIsk | Number of Participants With Clinically Significant Atrial Septal Defect (ASD) | 11 Participants |
Secondary
Number of Participants With Clinically Significant Atrial Septal Defect (ASD)
Defined as a significant residual atrial septal opening. Reported as clinically significant if intervention is performed for the primary purpose of repairing the ASD. If cardiac surgery is indicated for reasons other than residual ASD (e.g., residual MR) and the ASD is repaired at the same time, this does not meet the definition of clinically significant ASD.
Time frame: 12 months
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassionate Use | Number of Participants With Clinically Significant Atrial Septal Defect (ASD) | 3 Participants |
| Emergency Use | Number of Participants With Clinically Significant Atrial Septal Defect (ASD) | 0 Participants |
| High Risk | Number of Participants With Clinically Significant Atrial Septal Defect (ASD) | 22 Participants |
| Non-high RIsk | Number of Participants With Clinically Significant Atrial Septal Defect (ASD) | 15 Participants |
Secondary
Number of Participants With Clip Implant Rate
Defined as the procedural rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.
Time frame: On the day of index procedure (≤1 day)
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassionate Use | Number of Participants With Clip Implant Rate | 55 Participants |
| Emergency Use | Number of Participants With Clip Implant Rate | 7 Participants |
| High Risk | Number of Participants With Clip Implant Rate | 603 Participants |
| Non-high RIsk | Number of Participants With Clip Implant Rate | 258 Participants |
Secondary
Number of Participants With Device Embolization or Single Leaflet Device Attachment (SLDA)
A single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device.
Time frame: 0 to 5 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassionate Use | Number of Participants With Device Embolization or Single Leaflet Device Attachment (SLDA) | 0 Participants |
| Emergency Use | Number of Participants With Device Embolization or Single Leaflet Device Attachment (SLDA) | 1 Participants |
| High Risk | Number of Participants With Device Embolization or Single Leaflet Device Attachment (SLDA) | 13 Participants |
| Non-high RIsk | Number of Participants With Device Embolization or Single Leaflet Device Attachment (SLDA) | 11 Participants |
Secondary
Number of Participants With Hospital Re-admissions
Defined as re-admission of patients to the hospital following discharge from the Clip procedure.
Time frame: 30 days
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassionate Use | Number of Participants With Hospital Re-admissions | 7 Participants |
| Emergency Use | Number of Participants With Hospital Re-admissions | 1 Participants |
| High Risk | Number of Participants With Hospital Re-admissions | 74 Participants |
| Non-high RIsk | Number of Participants With Hospital Re-admissions | 15 Participants |
Secondary
Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility
Time frame: At discharge (an average of ≤ 12.3 days post-index procedure)
Population: ITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Compassionate Use | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Home | 51 Participants |
| Compassionate Use | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Long-term acute care | 1 Participants |
| Compassionate Use | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Death | 1 Participants |
| Compassionate Use | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Home with home health care | 3 Participants |
| Compassionate Use | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Nursing home | 0 Participants |
| Compassionate Use | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Skilled nursing facility | 3 Participants |
| Compassionate Use | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Withdrawal | 0 Participants |
| Emergency Use | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Death | 1 Participants |
| Emergency Use | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Home | 0 Participants |
| Emergency Use | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Home with home health care | 2 Participants |
| Emergency Use | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Skilled nursing facility | 4 Participants |
| Emergency Use | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Withdrawal | 0 Participants |
| Emergency Use | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Long-term acute care | 0 Participants |
| Emergency Use | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Nursing home | 0 Participants |
| High Risk | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Withdrawal | 1 Participants |
| High Risk | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Death | 12 Participants |
| High Risk | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Nursing home | 15 Participants |
| High Risk | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Long-term acute care | 0 Participants |
| High Risk | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Home | 523 Participants |
| High Risk | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Home with home health care | 43 Participants |
| High Risk | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Skilled nursing facility | 34 Participants |
| Non-high RIsk | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Withdrawal | 1 Participants |
| Non-high RIsk | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Home with home health care | 13 Participants |
| Non-high RIsk | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Nursing home | 3 Participants |
| Non-high RIsk | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Skilled nursing facility | 3 Participants |
| Non-high RIsk | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Long-term acute care | 1 Participants |
| Non-high RIsk | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Death | 2 Participants |
| Non-high RIsk | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility | Home | 248 Participants |
Secondary
Number of Participants With Major Adverse Events in Patients Over 75 Years of Age
MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.
Time frame: 2 years
Population: CU Arm:~There are 27 patients \>75 years old in the CU arm. Safety data are available only for 26 patients.~EU Arm:~There are 5 patients \>75 years old in the EU arm.~HR arm:~There are 393 patients \>75 years old in the HR arm.~Non-HR arm:~There are 140 patients \>75 years old in the Non-HR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassionate Use | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | 14 Participants |
| Emergency Use | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | 4 Participants |
| High Risk | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | 146 Participants |
| Non-high RIsk | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | 40 Participants |
Secondary
Number of Participants With Major Adverse Events in Patients Over 75 Years of Age
MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.
Time frame: 3 years
Population: CU Arm:~There are 27 patients \>75 years old in the CU arm. Safety data are available only for 26 patients.~EU Arm:~There are 5 patients \>75 years old in the EU arm.~HR arm:~There are 393 patients \>75 years old in the HR arm.~Non-HR arm:~There are 140 patients \>75 years old in the Non-HR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassionate Use | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | 14 Participants |
| Emergency Use | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | 4 Participants |
| High Risk | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | 146 Participants |
| Non-high RIsk | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | 40 Participants |
Secondary
Number of Participants With Major Adverse Events in Patients Over 75 Years of Age
MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.
Time frame: 4 years
Population: CU Arm:~There are 27 patients \>75 years old in the CU arm. Safety data are available only for 24 patients.~EU Arm:~There are 5 patients \>75 years old in the EU arm.~HR arm:~There are 393 patients \>75 years old in the HR arm.~Non-HR arm:~There are 140 patients \>75 years old in the Non-HR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassionate Use | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | 12 Participants |
| Emergency Use | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | 4 Participants |
| High Risk | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | 146 Participants |
| Non-high RIsk | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | 40 Participants |
Secondary
Number of Participants With Major Adverse Events in Patients Over 75 Years of Age
MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.
Time frame: 5 years
Population: CU Arm:~There are 27 patients \>75 years old in the CU arm. Safety data are available only for 24 patients.~EU Arm:~There are 5 patients \>75 years old in the EU arm.~HR arm:~There are 393 patients \>75 years old in the HR arm.~Non-HR arm:~There are 140 patients \>75 years old in the Non-HR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassionate Use | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | 12 Participants |
| Emergency Use | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | 4 Participants |
| High Risk | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | 146 Participants |
| Non-high RIsk | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | 40 Participants |
Secondary
Number of Participants With Major Adverse Events in Patients Over 75 Years of Age
MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.
Time frame: 12 Months
Population: CU Arm:~There are 27 patients \>75 years old in the CU arm. Safety data are available only for 26 patients.~EU Arm:~There are 5 patients \>75 years old in the EU arm.~HR arm:~There are 393 patients \>75 years old in the HR arm.~Non-HR arm:~There are 140 patients \>75 years old in the Non-HR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassionate Use | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | 14 Participants |
| Emergency Use | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | 3 Participants |
| High Risk | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | 139 Participants |
| Non-high RIsk | Number of Participants With Major Adverse Events in Patients Over 75 Years of Age | 40 Participants |
Secondary
Number of Participants With Major Adverse Events (MAE) in Patients Over 75 Years of Age
MAE is defined as a combined clinical endpoint of Death (all cause), MI, Re-operation for Failed Surgical Repair or replacement, non-elective Cardiovascular Surgery for AEs, Stroke, Renal Failure, Deep Wound Infection, Ventilation for greater than 48 hours, GI complication requiring surgery, new onset of Permanent Afib, Septicemia, and transfusion of 2 or more units of blood. The occurrence of MAE is measured in patients over 75 years of age.
Time frame: 30 days
Population: CU Arm:~There are 27 patients \>75 years old in the CU arm. Safety data are available only for 26 patients.~EU Arm:~There are 5 patients \>75 years old in the EU arm.~HR arm:~There are 393 patients \>75 years old in the HR arm.~Non-HR arm:~There are 140 patients \>75 years old in the Non-HR arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassionate Use | Number of Participants With Major Adverse Events (MAE) in Patients Over 75 Years of Age | 3 Participants |
| Emergency Use | Number of Participants With Major Adverse Events (MAE) in Patients Over 75 Years of Age | 2 Participants |
| High Risk | Number of Participants With Major Adverse Events (MAE) in Patients Over 75 Years of Age | 64 Participants |
| Non-high RIsk | Number of Participants With Major Adverse Events (MAE) in Patients Over 75 Years of Age | 16 Participants |
Secondary
Number of Participants With MitraClip Devices Implanted
The distribution of number of MitraClip devices implanted in patients.
Time frame: On the day of index procedure
Population: ITT population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Compassionate Use | Number of Participants With MitraClip Devices Implanted | 0 Clips | 4 Participants |
| Compassionate Use | Number of Participants With MitraClip Devices Implanted | 1 Clip | 30 Participants |
| Compassionate Use | Number of Participants With MitraClip Devices Implanted | 2 Clips | 25 Participants |
| Compassionate Use | Number of Participants With MitraClip Devices Implanted | 3 Clips | 0 Participants |
| Emergency Use | Number of Participants With MitraClip Devices Implanted | 1 Clip | 5 Participants |
| Emergency Use | Number of Participants With MitraClip Devices Implanted | 2 Clips | 2 Participants |
| Emergency Use | Number of Participants With MitraClip Devices Implanted | 3 Clips | 0 Participants |
| Emergency Use | Number of Participants With MitraClip Devices Implanted | 0 Clips | 0 Participants |
| High Risk | Number of Participants With MitraClip Devices Implanted | 2 Clips | 268 Participants |
| High Risk | Number of Participants With MitraClip Devices Implanted | 1 Clip | 333 Participants |
| High Risk | Number of Participants With MitraClip Devices Implanted | 3 Clips | 2 Participants |
| High Risk | Number of Participants With MitraClip Devices Implanted | 0 Clips | 25 Participants |
| Non-high RIsk | Number of Participants With MitraClip Devices Implanted | 3 Clips | 0 Participants |
| Non-high RIsk | Number of Participants With MitraClip Devices Implanted | 1 Clip | 160 Participants |
| Non-high RIsk | Number of Participants With MitraClip Devices Implanted | 0 Clips | 13 Participants |
| Non-high RIsk | Number of Participants With MitraClip Devices Implanted | 2 Clips | 98 Participants |
Secondary
Number of Participants With Mitral Regurgitation (MR) Severity
Paired site-assessed Mitral regurgitation severity between baseline and 30 days using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.
Time frame: 30 days(Follow-up)
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Compassionate Use | Number of Participants With Mitral Regurgitation (MR) Severity | 3+: Moderate to Severe | 11 Participants |
| Compassionate Use | Number of Participants With Mitral Regurgitation (MR) Severity | 1+: Mild | 22 Participants |
| Compassionate Use | Number of Participants With Mitral Regurgitation (MR) Severity | 4+: Severe | 3 Participants |
| Compassionate Use | Number of Participants With Mitral Regurgitation (MR) Severity | 2+: Moderate | 20 Participants |
| Compassionate Use | Number of Participants With Mitral Regurgitation (MR) Severity | 0+: None | 0 Participants |
| Emergency Use | Number of Participants With Mitral Regurgitation (MR) Severity | 2+: Moderate | 1 Participants |
| Emergency Use | Number of Participants With Mitral Regurgitation (MR) Severity | 3+: Moderate to Severe | 3 Participants |
| Emergency Use | Number of Participants With Mitral Regurgitation (MR) Severity | 4+: Severe | 0 Participants |
| Emergency Use | Number of Participants With Mitral Regurgitation (MR) Severity | 1+: Mild | 1 Participants |
| Emergency Use | Number of Participants With Mitral Regurgitation (MR) Severity | 0+: None | 0 Participants |
| High Risk | Number of Participants With Mitral Regurgitation (MR) Severity | 2+: Moderate | 206 Participants |
| High Risk | Number of Participants With Mitral Regurgitation (MR) Severity | 0+: None | 7 Participants |
| High Risk | Number of Participants With Mitral Regurgitation (MR) Severity | 1+: Mild | 315 Participants |
| High Risk | Number of Participants With Mitral Regurgitation (MR) Severity | 3+: Moderate to Severe | 50 Participants |
| High Risk | Number of Participants With Mitral Regurgitation (MR) Severity | 4+: Severe | 9 Participants |
| Non-high RIsk | Number of Participants With Mitral Regurgitation (MR) Severity | 3+: Moderate to Severe | 25 Participants |
| Non-high RIsk | Number of Participants With Mitral Regurgitation (MR) Severity | 1+: Mild | 144 Participants |
| Non-high RIsk | Number of Participants With Mitral Regurgitation (MR) Severity | 0+: None | 1 Participants |
| Non-high RIsk | Number of Participants With Mitral Regurgitation (MR) Severity | 2+: Moderate | 90 Participants |
| Non-high RIsk | Number of Participants With Mitral Regurgitation (MR) Severity | 4+: Severe | 4 Participants |
Secondary
Number of Participants With Mitral Stenosis
Mitral stenosis is a key safety consideration assessed after implantation of the MitraClip device. It is defined as Mitral Valve Area (MVA) less than 1.5 cm\^2 as assessed by the Echocardiography Core Laboratory (ECL).
Time frame: 0 to 5 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassionate Use | Number of Participants With Mitral Stenosis | 3 Participants |
| Emergency Use | Number of Participants With Mitral Stenosis | 0 Participants |
| High Risk | Number of Participants With Mitral Stenosis | 7 Participants |
| Non-high RIsk | Number of Participants With Mitral Stenosis | 6 Participants |
Secondary
Number of Participants With MR Severity
Paired site-assessed Mitral regurgitation severity between baseline and 12 months using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Compassionate Use | Number of Participants With MR Severity | 3+: Moderate to Severe | 3 Participants |
| Compassionate Use | Number of Participants With MR Severity | 1+: Mild | 17 Participants |
| Compassionate Use | Number of Participants With MR Severity | 4+: Severe | 3 Participants |
| Compassionate Use | Number of Participants With MR Severity | 2+: Moderate | 10 Participants |
| Compassionate Use | Number of Participants With MR Severity | 0+: None | 1 Participants |
| Emergency Use | Number of Participants With MR Severity | 2+: Moderate | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 3+: Moderate to Severe | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 0+: None | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 4+: Severe | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 1+: Mild | 0 Participants |
| High Risk | Number of Participants With MR Severity | 2+: Moderate | 173 Participants |
| High Risk | Number of Participants With MR Severity | 1+: Mild | 167 Participants |
| High Risk | Number of Participants With MR Severity | 0+: None | 6 Participants |
| High Risk | Number of Participants With MR Severity | 3+: Moderate to Severe | 48 Participants |
| High Risk | Number of Participants With MR Severity | 4+: Severe | 16 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 3+: Moderate to Severe | 31 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 1+: Mild | 71 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 0+: None | 3 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 2+: Moderate | 100 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 4+: Severe | 4 Participants |
Secondary
Number of Participants With MR Severity
Paired site-assessed Mitral regurgitation severity between baseline and 2 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.
Time frame: 2 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Compassionate Use | Number of Participants With MR Severity | 3+: Moderate to Severe | 1 Participants |
| Compassionate Use | Number of Participants With MR Severity | 1+: Mild | 6 Participants |
| Compassionate Use | Number of Participants With MR Severity | 4+: Severe | 0 Participants |
| Compassionate Use | Number of Participants With MR Severity | 2+: Moderate | 3 Participants |
| Compassionate Use | Number of Participants With MR Severity | 0+: None | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 2+: Moderate | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 3+: Moderate to Severe | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 4+: Severe | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 1+: Mild | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 0+: None | 0 Participants |
| High Risk | Number of Participants With MR Severity | 2+: Moderate | 90 Participants |
| High Risk | Number of Participants With MR Severity | 0+: None | 0 Participants |
| High Risk | Number of Participants With MR Severity | 1+: Mild | 102 Participants |
| High Risk | Number of Participants With MR Severity | 3+: Moderate to Severe | 23 Participants |
| High Risk | Number of Participants With MR Severity | 4+: Severe | 12 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 3+: Moderate to Severe | 21 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 1+: Mild | 65 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 0+: None | 4 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 2+: Moderate | 87 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 4+: Severe | 2 Participants |
Secondary
Number of Participants With MR Severity
Paired site-assessed Mitral regurgitation severity between baseline and 3 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.
Time frame: 3 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Compassionate Use | Number of Participants With MR Severity | 3+: Moderate to Severe | 0 Participants |
| Compassionate Use | Number of Participants With MR Severity | 1+: Mild | 5 Participants |
| Compassionate Use | Number of Participants With MR Severity | 4+: Severe | 0 Participants |
| Compassionate Use | Number of Participants With MR Severity | 2+: Moderate | 2 Participants |
| Compassionate Use | Number of Participants With MR Severity | 0+: None | 1 Participants |
| Emergency Use | Number of Participants With MR Severity | 2+: Moderate | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 3+: Moderate to Severe | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 4+: Severe | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 1+: Mild | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 0+: None | 0 Participants |
| High Risk | Number of Participants With MR Severity | 2+: Moderate | 90 Participants |
| High Risk | Number of Participants With MR Severity | 0+: None | 1 Participants |
| High Risk | Number of Participants With MR Severity | 1+: Mild | 103 Participants |
| High Risk | Number of Participants With MR Severity | 3+: Moderate to Severe | 20 Participants |
| High Risk | Number of Participants With MR Severity | 4+: Severe | 8 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 3+: Moderate to Severe | 15 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 1+: Mild | 58 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 0+: None | 8 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 2+: Moderate | 73 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 4+: Severe | 5 Participants |
Secondary
Number of Participants With MR Severity
Paired site-assessed Mitral regurgitation severity between baseline and 4 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.
Time frame: 4 years
Population: The 4-year visit was optional and no data were collected at this time point for CU and EU arm.~The number of participants analyzed includes subjects who had available follow up data at that time frame in HR and Non-HR arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Compassionate Use | Number of Participants With MR Severity | 3+: Moderate to Severe | 0 Participants |
| Compassionate Use | Number of Participants With MR Severity | 1+: Mild | 0 Participants |
| Compassionate Use | Number of Participants With MR Severity | 4+: Severe | 0 Participants |
| Compassionate Use | Number of Participants With MR Severity | 2+: Moderate | 0 Participants |
| Compassionate Use | Number of Participants With MR Severity | 0+: None | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 2+: Moderate | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 3+: Moderate to Severe | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 4+: Severe | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 1+: Mild | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 0+: None | 0 Participants |
| High Risk | Number of Participants With MR Severity | 2+: Moderate | 32 Participants |
| High Risk | Number of Participants With MR Severity | 0+: None | 0 Participants |
| High Risk | Number of Participants With MR Severity | 1+: Mild | 29 Participants |
| High Risk | Number of Participants With MR Severity | 3+: Moderate to Severe | 4 Participants |
| High Risk | Number of Participants With MR Severity | 4+: Severe | 1 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 3+: Moderate to Severe | 14 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 1+: Mild | 26 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 0+: None | 3 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 2+: Moderate | 22 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 4+: Severe | 2 Participants |
Secondary
Number of Participants With MR Severity
Paired site-assessed Mitral regurgitation severity between baseline and 5 years using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 2+ is moderate, 3+ is moderate-to-severe and 4+ is severe.
Time frame: 5 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Compassionate Use | Number of Participants With MR Severity | 1+:Mild | 4 Participants |
| Compassionate Use | Number of Participants With MR Severity | 0+:None | 0 Participants |
| Compassionate Use | Number of Participants With MR Severity | 2+:Moderate | 1 Participants |
| Compassionate Use | Number of Participants With MR Severity | 4+:Severe | 0 Participants |
| Compassionate Use | Number of Participants With MR Severity | 3+:Moderate to Severe | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 2+:Moderate | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 0+:None | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 1+:Mild | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 3+:Moderate to Severe | 0 Participants |
| Emergency Use | Number of Participants With MR Severity | 4+:Severe | 0 Participants |
| High Risk | Number of Participants With MR Severity | 2+:Moderate | 43 Participants |
| High Risk | Number of Participants With MR Severity | 0+:None | 2 Participants |
| High Risk | Number of Participants With MR Severity | 4+:Severe | 3 Participants |
| High Risk | Number of Participants With MR Severity | 3+:Moderate to Severe | 10 Participants |
| High Risk | Number of Participants With MR Severity | 1+:Mild | 50 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 3+:Moderate to Severe | 9 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 2+:Moderate | 48 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 0+:None | 4 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 4+:Severe | 6 Participants |
| Non-high RIsk | Number of Participants With MR Severity | 1+:Mild | 50 Participants |
Secondary
Number of Participants With New York Heart Association (NYHA) Functional Class
Paired NYHA data from baseline to 30 days. 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. They 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: 30 days
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Compassionate Use | Number of Participants With New York Heart Association (NYHA) Functional Class | NYHA Functional Class I | 17 Participants |
| Compassionate Use | Number of Participants With New York Heart Association (NYHA) Functional Class | NYHA Functional Class II | 22 Participants |
| Compassionate Use | Number of Participants With New York Heart Association (NYHA) Functional Class | NYHA Functional Class III | 10 Participants |
| Compassionate Use | Number of Participants With New York Heart Association (NYHA) Functional Class | NYHA Functional Class IV | 1 Participants |
| Emergency Use | Number of Participants With New York Heart Association (NYHA) Functional Class | NYHA Functional Class II | 2 Participants |
| Emergency Use | Number of Participants With New York Heart Association (NYHA) Functional Class | NYHA Functional Class III | 1 Participants |
| Emergency Use | Number of Participants With New York Heart Association (NYHA) Functional Class | NYHA Functional Class IV | 0 Participants |
| Emergency Use | Number of Participants With New York Heart Association (NYHA) Functional Class | NYHA Functional Class I | 0 Participants |
| High Risk | Number of Participants With New York Heart Association (NYHA) Functional Class | NYHA Functional Class III | 88 Participants |
| High Risk | Number of Participants With New York Heart Association (NYHA) Functional Class | NYHA Functional Class II | 296 Participants |
| High Risk | Number of Participants With New York Heart Association (NYHA) Functional Class | NYHA Functional Class IV | 13 Participants |
| High Risk | Number of Participants With New York Heart Association (NYHA) Functional Class | NYHA Functional Class I | 163 Participants |
| Non-high RIsk | Number of Participants With New York Heart Association (NYHA) Functional Class | NYHA Functional Class IV | 1 Participants |
| Non-high RIsk | Number of Participants With New York Heart Association (NYHA) Functional Class | NYHA Functional Class II | 110 Participants |
| Non-high RIsk | Number of Participants With New York Heart Association (NYHA) Functional Class | NYHA Functional Class I | 113 Participants |
| Non-high RIsk | Number of Participants With New York Heart Association (NYHA) Functional Class | NYHA Functional Class III | 28 Participants |
Secondary
Number of Participants With NYHA Functional Class
Paired NYHA data from baseline to 5 years. 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. They 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: 5 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Compassionate Use | Number of Participants With NYHA Functional Class | NYHA Functional Class I | 1 Participants |
| Compassionate Use | Number of Participants With NYHA Functional Class | NYHA Functional Class II | 3 Participants |
| Compassionate Use | Number of Participants With NYHA Functional Class | NYHA Functional Class III | 1 Participants |
| Compassionate Use | Number of Participants With NYHA Functional Class | NYHA Functional Class IV | 1 Participants |
| Emergency Use | Number of Participants With NYHA Functional Class | NYHA Functional Class II | 0 Participants |
| Emergency Use | Number of Participants With NYHA Functional Class | NYHA Functional Class III | 0 Participants |
| Emergency Use | Number of Participants With NYHA Functional Class | NYHA Functional Class IV | 0 Participants |
| Emergency Use | Number of Participants With NYHA Functional Class | NYHA Functional Class I | 0 Participants |
| High Risk | Number of Participants With NYHA Functional Class | NYHA Functional Class III | 12 Participants |
| High Risk | Number of Participants With NYHA Functional Class | NYHA Functional Class II | 48 Participants |
| High Risk | Number of Participants With NYHA Functional Class | NYHA Functional Class IV | 9 Participants |
| High Risk | Number of Participants With NYHA Functional Class | NYHA Functional Class I | 52 Participants |
| Non-high RIsk | Number of Participants With NYHA Functional Class | NYHA Functional Class IV | 0 Participants |
| Non-high RIsk | Number of Participants With NYHA Functional Class | NYHA Functional Class II | 49 Participants |
| Non-high RIsk | Number of Participants With NYHA Functional Class | NYHA Functional Class I | 65 Participants |
| Non-high RIsk | Number of Participants With NYHA Functional Class | NYHA Functional Class III | 5 Participants |
Secondary
Number of Participants With NYHA Functional Class
Paired NYHA data from baseline to 4 years. 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. They 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: 4 years
Population: The 4-year visit was optional and no data were collected at this time point for CU and EU arm.~The number of participants analyzed includes subjects who had available follow up data at that time frame in HR and Non-HR arm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Compassionate Use | Number of Participants With NYHA Functional Class | NYHA Functional Class I | 0 Participants |
| Compassionate Use | Number of Participants With NYHA Functional Class | NYHA Functional Class II | 0 Participants |
| Compassionate Use | Number of Participants With NYHA Functional Class | NYHA Functional Class III | 0 Participants |
| Compassionate Use | Number of Participants With NYHA Functional Class | NYHA Functional Class IV | 0 Participants |
| Emergency Use | Number of Participants With NYHA Functional Class | NYHA Functional Class II | 0 Participants |
| Emergency Use | Number of Participants With NYHA Functional Class | NYHA Functional Class III | 0 Participants |
| Emergency Use | Number of Participants With NYHA Functional Class | NYHA Functional Class IV | 0 Participants |
| Emergency Use | Number of Participants With NYHA Functional Class | NYHA Functional Class I | 0 Participants |
| High Risk | Number of Participants With NYHA Functional Class | NYHA Functional Class III | 14 Participants |
| High Risk | Number of Participants With NYHA Functional Class | NYHA Functional Class II | 47 Participants |
| High Risk | Number of Participants With NYHA Functional Class | NYHA Functional Class IV | 0 Participants |
| High Risk | Number of Participants With NYHA Functional Class | NYHA Functional Class I | 44 Participants |
| Non-high RIsk | Number of Participants With NYHA Functional Class | NYHA Functional Class IV | 3 Participants |
| Non-high RIsk | Number of Participants With NYHA Functional Class | NYHA Functional Class II | 35 Participants |
| Non-high RIsk | Number of Participants With NYHA Functional Class | NYHA Functional Class I | 76 Participants |
| Non-high RIsk | Number of Participants With NYHA Functional Class | NYHA Functional Class III | 11 Participants |
Secondary
Number of Participants With NYHA Functional Class
Paired NYHA data from baseline to 12 months. 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. They 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: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Compassionate Use | Number of Participants With NYHA Functional Class | NYHA Functional Class I | 14 Participants |
| Compassionate Use | Number of Participants With NYHA Functional Class | NYHA Functional Class II | 13 Participants |
| Compassionate Use | Number of Participants With NYHA Functional Class | NYHA Functional Class III | 7 Participants |
| Compassionate Use | Number of Participants With NYHA Functional Class | NYHA Functional Class IV | 1 Participants |
| Emergency Use | Number of Participants With NYHA Functional Class | NYHA Functional Class II | 0 Participants |
| Emergency Use | Number of Participants With NYHA Functional Class | NYHA Functional Class III | 0 Participants |
| Emergency Use | Number of Participants With NYHA Functional Class | NYHA Functional Class IV | 0 Participants |
| Emergency Use | Number of Participants With NYHA Functional Class | NYHA Functional Class I | 0 Participants |
| High Risk | Number of Participants With NYHA Functional Class | NYHA Functional Class III | 61 Participants |
| High Risk | Number of Participants With NYHA Functional Class | NYHA Functional Class II | 179 Participants |
| High Risk | Number of Participants With NYHA Functional Class | NYHA Functional Class IV | 6 Participants |
| High Risk | Number of Participants With NYHA Functional Class | NYHA Functional Class I | 157 Participants |
| Non-high RIsk | Number of Participants With NYHA Functional Class | NYHA Functional Class IV | 0 Participants |
| Non-high RIsk | Number of Participants With NYHA Functional Class | NYHA Functional Class II | 65 Participants |
| Non-high RIsk | Number of Participants With NYHA Functional Class | NYHA Functional Class I | 121 Participants |
| Non-high RIsk | Number of Participants With NYHA Functional Class | NYHA Functional Class III | 18 Participants |
Secondary
Number of Participants With NYHA Functional Class
Paired NYHA data from baseline to 2 years. 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. They 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: 2 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Compassionate Use | Number of Participants With NYHA Functional Class | NYHA Functional Class I | 6 Participants |
| Compassionate Use | Number of Participants With NYHA Functional Class | NYHA Functional Class II | 11 Participants |
| Compassionate Use | Number of Participants With NYHA Functional Class | NYHA Functional Class III | 5 Participants |
| Compassionate Use | Number of Participants With NYHA Functional Class | NYHA Functional Class IV | 1 Participants |
| Emergency Use | Number of Participants With NYHA Functional Class | NYHA Functional Class II | 0 Participants |
| Emergency Use | Number of Participants With NYHA Functional Class | NYHA Functional Class III | 0 Participants |
| Emergency Use | Number of Participants With NYHA Functional Class | NYHA Functional Class IV | 0 Participants |
| Emergency Use | Number of Participants With NYHA Functional Class | NYHA Functional Class I | 0 Participants |
| High Risk | Number of Participants With NYHA Functional Class | NYHA Functional Class III | 49 Participants |
| High Risk | Number of Participants With NYHA Functional Class | NYHA Functional Class II | 126 Participants |
| High Risk | Number of Participants With NYHA Functional Class | NYHA Functional Class IV | 5 Participants |
| High Risk | Number of Participants With NYHA Functional Class | NYHA Functional Class I | 113 Participants |
| Non-high RIsk | Number of Participants With NYHA Functional Class | NYHA Functional Class IV | 1 Participants |
| Non-high RIsk | Number of Participants With NYHA Functional Class | NYHA Functional Class II | 68 Participants |
| Non-high RIsk | Number of Participants With NYHA Functional Class | NYHA Functional Class I | 99 Participants |
| Non-high RIsk | Number of Participants With NYHA Functional Class | NYHA Functional Class III | 14 Participants |
Secondary
Number of Participants With NYHA Functional Class
Paired NYHA data from baseline to 3 years. 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. They 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: 3 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Compassionate Use | Number of Participants With NYHA Functional Class | NYHA Functional Class I | 7 Participants |
| Compassionate Use | Number of Participants With NYHA Functional Class | NYHA Functional Class II | 6 Participants |
| Compassionate Use | Number of Participants With NYHA Functional Class | NYHA Functional Class III | 1 Participants |
| Compassionate Use | Number of Participants With NYHA Functional Class | NYHA Functional Class IV | 0 Participants |
| Emergency Use | Number of Participants With NYHA Functional Class | NYHA Functional Class II | 0 Participants |
| Emergency Use | Number of Participants With NYHA Functional Class | NYHA Functional Class III | 0 Participants |
| Emergency Use | Number of Participants With NYHA Functional Class | NYHA Functional Class IV | 0 Participants |
| Emergency Use | Number of Participants With NYHA Functional Class | NYHA Functional Class I | 0 Participants |
| High Risk | Number of Participants With NYHA Functional Class | NYHA Functional Class III | 34 Participants |
| High Risk | Number of Participants With NYHA Functional Class | NYHA Functional Class II | 101 Participants |
| High Risk | Number of Participants With NYHA Functional Class | NYHA Functional Class IV | 7 Participants |
| High Risk | Number of Participants With NYHA Functional Class | NYHA Functional Class I | 82 Participants |
| Non-high RIsk | Number of Participants With NYHA Functional Class | NYHA Functional Class IV | 1 Participants |
| Non-high RIsk | Number of Participants With NYHA Functional Class | NYHA Functional Class II | 56 Participants |
| Non-high RIsk | Number of Participants With NYHA Functional Class | NYHA Functional Class I | 85 Participants |
| Non-high RIsk | Number of Participants With NYHA Functional Class | NYHA Functional Class III | 12 Participants |
Secondary
Number of Participants With Procedural Success
Defined as successful implantation of the Clip(s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA at 30 days.
Time frame: 30 days
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassionate Use | Number of Participants With Procedural Success | 45 Participants |
| Emergency Use | Number of Participants With Procedural Success | 4 Participants |
| High Risk | Number of Participants With Procedural Success | 541 Participants |
| Non-high RIsk | Number of Participants With Procedural Success | 239 Participants |
Secondary
Number of Participants With Second Intervention to Place an Additional Mitraclip Device.
If residual MR was determined to be clinically unacceptable for patients who received only 1 clip during the index procedure, a second intervention to place an additional MitraClip device could be considered.
Time frame: 5 years
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassionate Use | Number of Participants With Second Intervention to Place an Additional Mitraclip Device. | 1 Participants |
| Emergency Use | Number of Participants With Second Intervention to Place an Additional Mitraclip Device. | 0 Participants |
| High Risk | Number of Participants With Second Intervention to Place an Additional Mitraclip Device. | 33 Participants |
| Non-high RIsk | Number of Participants With Second Intervention to Place an Additional Mitraclip Device. | 11 Participants |
Secondary
Number of Participants With Second Intervention to Place an Additional Mitraclip Device.
If residual MR was determined to be clinically unacceptable for patients who received only 1 clip during the index procedure, a second intervention to place an additional MitraClip device could be considered.
Time frame: 139 days post the index procedure
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassionate Use | Number of Participants With Second Intervention to Place an Additional Mitraclip Device. | 1 Participants |
| Emergency Use | Number of Participants With Second Intervention to Place an Additional Mitraclip Device. | 0 Participants |
| High Risk | Number of Participants With Second Intervention to Place an Additional Mitraclip Device. | 12 Participants |
| Non-high RIsk | Number of Participants With Second Intervention to Place an Additional Mitraclip Device. | 3 Participants |
Secondary
Number of Participants With Serious Adverse Events
The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization.
Time frame: 12 months
Population: ITT population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Compassionate Use | Number of Participants With Serious Adverse Events | 37 Participants |
| Emergency Use | Number of Participants With Serious Adverse Events | 7 Participants |
| High Risk | Number of Participants With Serious Adverse Events | 388 Participants |
| Non-high RIsk | Number of Participants With Serious Adverse Events | 131 Participants |
Secondary
Number of Participants With Serious Adverse Events
The definition of a serious adverse event is an event that is fatal or life threatening, results in persistent or significant disability, requires intervention to prevent permanent impairment/damage, or an event that results in congenital anomaly, malignancy, hospital admission or prolongation of hospitalization.
Time frame: 30 days
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Compassionate Use | Number of Participants With Serious Adverse Events | 11 participants |
| Emergency Use | Number of Participants With Serious Adverse Events | 5 participants |
| High Risk | Number of Participants With Serious Adverse Events | 204 participants |
| Non-high RIsk | Number of Participants With Serious Adverse Events | 68 participants |
Secondary
Post-Procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU)/ Post-anesthesia Care Unit (PACU) Duration
Defined as the number of hours for which patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.
Time frame: At discharge (an average of ≤ 12.3 days post-index procedure).
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Post-Procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU)/ Post-anesthesia Care Unit (PACU) Duration | 22.1 Hours | Standard Deviation 29.9 |
| Emergency Use | Post-Procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU)/ Post-anesthesia Care Unit (PACU) Duration | 149.3 Hours | Standard Deviation 179.3 |
| High Risk | Post-Procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU)/ Post-anesthesia Care Unit (PACU) Duration | 36.5 Hours | Standard Deviation 70.3 |
| Non-high RIsk | Post-Procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU)/ Post-anesthesia Care Unit (PACU) Duration | 28.8 Hours | Standard Deviation 69.5 |
Secondary
Post-Procedure Length of Hospital Stay
Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility.
Time frame: At discharge (an average of ≤ 12.3 days post-index procedure).
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Post-Procedure Length of Hospital Stay | 2.4 Days | Standard Deviation 2.4 |
| Emergency Use | Post-Procedure Length of Hospital Stay | 12.3 Days | Standard Deviation 7.5 |
| High Risk | Post-Procedure Length of Hospital Stay | 3.2 Days | Standard Deviation 4.6 |
| Non-high RIsk | Post-Procedure Length of Hospital Stay | 2.8 Days | Standard Deviation 4.8 |
Secondary
Procedure Time
The mean procedure time is defined as the start time of the transseptal procedure to the time the steerable guide catheter (SGC) is removed.
Time frame: On the day of index procedure
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Procedure Time | 141.7 minutes | Standard Deviation 70.4 |
| Emergency Use | Procedure Time | 123.6 minutes | Standard Deviation 55.9 |
| High Risk | Procedure Time | 139.0 minutes | Standard Deviation 66.8 |
| Non-high RIsk | Procedure Time | 137.8 minutes | Standard Deviation 68.4 |
Secondary
Septal-Lateral Annular Dimension Diastole (SLADd)
Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to discharge or 30 days as determined by echo core laboratory.
Time frame: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Septal-Lateral Annular Dimension Diastole (SLADd) | 4.1 cm | Standard Deviation 0.5 |
| Emergency Use | Septal-Lateral Annular Dimension Diastole (SLADd) | 3.7 cm | Standard Deviation 0.5 |
| High Risk | Septal-Lateral Annular Dimension Diastole (SLADd) | 3.8 cm | Standard Deviation 0.5 |
| Non-high RIsk | Septal-Lateral Annular Dimension Diastole (SLADd) | 3.8 cm | Standard Deviation 0.5 |
Secondary
Septal-Lateral Annular Dimension Diastole (SLADd)
Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 12 months as determined by echo core laboratory.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Septal-Lateral Annular Dimension Diastole (SLADd) | 3.9 cm | Standard Deviation 0.4 |
| High Risk | Septal-Lateral Annular Dimension Diastole (SLADd) | 3.8 cm | Standard Deviation 0.5 |
| Non-high RIsk | Septal-Lateral Annular Dimension Diastole (SLADd) | 3.8 cm | Standard Deviation 0.5 |
Secondary
Septal-Lateral Annular Dimension Diastole (SLADd)
Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 24 months as determined by echo core laboratory.
Time frame: 24 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Septal-Lateral Annular Dimension Diastole (SLADd) | 3.9 cm | Standard Deviation 0.2 |
| High Risk | Septal-Lateral Annular Dimension Diastole (SLADd) | 3.8 cm | Standard Deviation 0.5 |
| Non-high RIsk | Septal-Lateral Annular Dimension Diastole (SLADd) | 3.8 cm | Standard Deviation 0.5 |
Secondary
Septal-Lateral Annular Dimension Diastole (SLADd)
Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 36 months as determined by echo core laboratory.
Time frame: 36 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Septal-Lateral Annular Dimension Diastole (SLADd) | 4.0 cm | Standard Deviation 0.3 |
| High Risk | Septal-Lateral Annular Dimension Diastole (SLADd) | 3.9 cm | Standard Deviation 0.5 |
| Non-high RIsk | Septal-Lateral Annular Dimension Diastole (SLADd) | 4.0 cm | Standard Deviation 0.5 |
Secondary
Septal-Lateral Annular Dimension Diastole (SLADd)
Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 48 months as determined by echo core laboratory.
Time frame: 48 months
Population: For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Risk | Septal-Lateral Annular Dimension Diastole (SLADd) | 4.0 cm | Standard Deviation 0.5 |
| Non-high RIsk | Septal-Lateral Annular Dimension Diastole (SLADd) | 4.1 cm | Standard Deviation 0.6 |
Secondary
Septal-Lateral Annular Dimension Diastole (SLADd)
Septal-Lateral Annular Dimension Diastole (SLADd) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in diastole. Paired SLADd data from baseline to 60 months as determined by echo core laboratory.
Time frame: 60 months
Population: For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Risk | Septal-Lateral Annular Dimension Diastole (SLADd) | 3.9 cm | Standard Deviation 0.5 |
| Non-high RIsk | Septal-Lateral Annular Dimension Diastole (SLADd) | 4.0 cm | Standard Deviation 0.6 |
Secondary
Septal-Lateral Annular Dimension Systole (SLADs)
Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 12 months as determined by echo core laboratory.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Septal-Lateral Annular Dimension Systole (SLADs) | 3.4 cm | Standard Deviation 0.4 |
| High Risk | Septal-Lateral Annular Dimension Systole (SLADs) | 3.3 cm | Standard Deviation 0.5 |
| Non-high RIsk | Septal-Lateral Annular Dimension Systole (SLADs) | 3.4 cm | Standard Deviation 0.5 |
Secondary
Septal-Lateral Annular Dimension Systole (SLADs)
Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to discharge or 30 days as determined by echo core laboratory.
Time frame: At discharge (an average of ≤ 12.3 days post-index procedure) or 30 days
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Septal-Lateral Annular Dimension Systole (SLADs) | 3.5 cm | Standard Deviation 0.4 |
| Emergency Use | Septal-Lateral Annular Dimension Systole (SLADs) | 3.3 cm | Standard Deviation 0.6 |
| High Risk | Septal-Lateral Annular Dimension Systole (SLADs) | 3.4 cm | Standard Deviation 0.5 |
| Non-high RIsk | Septal-Lateral Annular Dimension Systole (SLADs) | 3.5 cm | Standard Deviation 0.4 |
Secondary
Septal-Lateral Annular Dimension Systole (SLADs)
Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 24 months as determined by echo core laboratory.
Time frame: 24 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Septal-Lateral Annular Dimension Systole (SLADs) | 3.4 cm | Standard Deviation 0.3 |
| High Risk | Septal-Lateral Annular Dimension Systole (SLADs) | 3.3 cm | Standard Deviation 0.5 |
| Non-high RIsk | Septal-Lateral Annular Dimension Systole (SLADs) | 3.4 cm | Standard Deviation 0.5 |
Secondary
Septal-Lateral Annular Dimension Systole (SLADs)
Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 36 months as determined by echo core laboratory.
Time frame: 36 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Compassionate Use | Septal-Lateral Annular Dimension Systole (SLADs) | 3.5 cm | Standard Deviation 0.4 |
| High Risk | Septal-Lateral Annular Dimension Systole (SLADs) | 3.4 cm | Standard Deviation 0.5 |
| Non-high RIsk | Septal-Lateral Annular Dimension Systole (SLADs) | 3.4 cm | Standard Deviation 0.5 |
Secondary
Septal-Lateral Annular Dimension Systole (SLADs)
Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 48 months as determined by echo core laboratory.
Time frame: 48 months
Population: For CU arm, there is no paired data available for 48 months as very few patients completed the 4 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Risk | Septal-Lateral Annular Dimension Systole (SLADs) | 3.4 cm | Standard Deviation 0.5 |
| Non-high RIsk | Septal-Lateral Annular Dimension Systole (SLADs) | 3.5 cm | Standard Deviation 0.6 |
Secondary
Septal-Lateral Annular Dimension Systole (SLADs)
Septal-Lateral Annular Dimension systole (SLADs) is the dimension across the mitral valve from the anterior annulus to the posterior annulus at the widest point in the center of the valve, measured in systole.Paired SLADs data from baseline to 60 months as determined by echo core laboratory.
Time frame: 60 months
Population: For CU arm, there is no paired data available for 60 months as very few patients completed the 5 year follow-up and in EU arm all the patients died prior to 48 months. Thus the number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Risk | Septal-Lateral Annular Dimension Systole (SLADs) | 3.4 cm | Standard Deviation 0.6 |
| Non-high RIsk | Septal-Lateral Annular Dimension Systole (SLADs) | 3.5 cm | Standard Deviation 0.6 |
Other Pre-specified
36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 12 Months
The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts: * Physical functioning * Role limitations due to physical or * Emotional health * Bodily pain * General health perceptions * Vitality * Social functioning * General mental health Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health. The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively.
Time frame: 12 months
Population: EU arm participants were not analyzed due to the serious/life-threatening conditions, QOL data was not collected on all patients at baseline. Therefore, paired data at 1 year were not available for EU arm.~The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Compassionate Use | 36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 12 Months | Physical Component Summary | 7.2 Scores on a scale | Standard Deviation 10.7 |
| Compassionate Use | 36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 12 Months | Mental Component Summary | 6.7 Scores on a scale | Standard Deviation 12 |
| Emergency Use | 36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 12 Months | Physical Component Summary | 38.9 Scores on a scale | Standard Deviation 10.6 |
| Emergency Use | 36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 12 Months | Mental Component Summary | 50.3 Scores on a scale | Standard Deviation 11.9 |
| High Risk | 36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 12 Months | Physical Component Summary | 43.2 Scores on a scale | Standard Deviation 10.6 |
| High Risk | 36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 12 Months | Mental Component Summary | 51.3 Scores on a scale | Standard Deviation 10.5 |
Other Pre-specified
36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 30 Days
The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts: * Physical functioning * Role limitations due to physical or * Emotional health * Bodily pain * General health perceptions * Vitality * Social functioning * General mental health Responses to each of the SF-36 items are scored and expressed as a score on a 0-100 scale (0% in a domain represents the poorest possible QOL&100% indicates full QOL).Higher scores represent better self-perceived health. The physical & mental functions were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. Normal PCS and MCS scores vary depending on the demographics of the population studied. The PCS&MCS norms for 65-75 year old are 44 & 52, respectively while the norms for CHF population are 31 & 46, respectively.
Time frame: 30 days
Population: EU arm participants were not analyzed due to the serious/life-threatening conditions,SF-36 QOL data was not collected on all patients at baseline. Therefore, paired data at 30 days were not available for EU arm.~The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Compassionate Use | 36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 30 Days | Physical Component Summary | 7.6 Scores on a scale | Standard Deviation 9.6 |
| Compassionate Use | 36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 30 Days | Mental Component Summary | 5.3 Scores on a scale | Standard Deviation 11.3 |
| Emergency Use | 36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 30 Days | Physical Component Summary | 38.3 Scores on a scale | Standard Deviation 10 |
| Emergency Use | 36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 30 Days | Mental Component Summary | 49.3 Scores on a scale | Standard Deviation 12 |
| High Risk | 36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 30 Days | Physical Component Summary | 40.7 Scores on a scale | Standard Deviation 9.6 |
| High Risk | 36-Item Short Form Health Survey (SF-36) Quality of Life Change From Baseline to 30 Days | Mental Component Summary | 52.5 Scores on a scale | Standard Deviation 10.3 |
Other Pre-specified
Change in 6-Minute Walk Test (6MWT)
Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes.
Time frame: At Baseline and 30 Days
Population: EU arm participants were not analyzed due to serious/life-threatening conditions, the 6MWT was not administered to all patients at baseline.Therefore,paired data at 30 days were not available for EU arm.~The number of participants analyzed includes subjects who had available follow up data at that time frame in CU, HR and Non-HR arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Compassionate Use | Change in 6-Minute Walk Test (6MWT) | 30 Days | 296.6 Meters | Standard Deviation 186.8 |
| Compassionate Use | Change in 6-Minute Walk Test (6MWT) | Baseline | 243.1 Meters | Standard Deviation 124.6 |
| Compassionate Use | Change in 6-Minute Walk Test (6MWT) | Difference | 53.4 Meters | Standard Deviation 131.4 |
| Emergency Use | Change in 6-Minute Walk Test (6MWT) | 30 Days | 278.8 Meters | Standard Deviation 162.7 |
| Emergency Use | Change in 6-Minute Walk Test (6MWT) | Baseline | 237.8 Meters | Standard Deviation 141.9 |
| Emergency Use | Change in 6-Minute Walk Test (6MWT) | Difference | 40.9 Meters | Standard Deviation 108.6 |
| High Risk | Change in 6-Minute Walk Test (6MWT) | Baseline | 386.7 Meters | Standard Deviation 396.8 |
| High Risk | Change in 6-Minute Walk Test (6MWT) | Difference | 42.1 Meters | Standard Deviation 293.5 |
| High Risk | Change in 6-Minute Walk Test (6MWT) | 30 Days | 428.9 Meters | Standard Deviation 296.4 |
Other Pre-specified
Change in 6-Minute Walk Test (6MWT)
Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes.
Time frame: At Baseline and 6 months
Population: EU and CU arm participants were not analyzed due to serious/life-threatening conditions, the 6MWT was not administered to all patients at baseline.Therefore, paired data at 6 months were not available for EU and CU arm.~The number of participants analyzed includes subjects who had available follow up data at that time frame HR and Non-HR arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Compassionate Use | Change in 6-Minute Walk Test (6MWT) | Baseline | 252.0 Meters | Standard Deviation 142.5 |
| Compassionate Use | Change in 6-Minute Walk Test (6MWT) | 6 Months | 283.8 Meters | Standard Deviation 147.9 |
| Compassionate Use | Change in 6-Minute Walk Test (6MWT) | Difference | 31.8 Meters | Standard Deviation 134.7 |
| Emergency Use | Change in 6-Minute Walk Test (6MWT) | Baseline | 413.6 Meters | Standard Deviation 406.4 |
| Emergency Use | Change in 6-Minute Walk Test (6MWT) | 6 Months | 392.8 Meters | Standard Deviation 245.1 |
| Emergency Use | Change in 6-Minute Walk Test (6MWT) | Difference | -20.9 Meters | Standard Deviation 333.2 |
Other Pre-specified
Change in 6-Minute Walk Test (6MWT)
Defined as a cardiopulmonary function test that measures a patient's exercise capacity by the distance he or she can walk in six minutes.
Time frame: At Baseline and 12 months
Population: EU arm participants were not analyzed due to serious/life-threatening conditions, the 6MWT was not administered to all patients at baseline.Therefore, paired data at 1 year were not available for EU arm.~The number of participants analyzed includes subjects who had available follow up data at that time frame in CU, HR and Non-HR arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Compassionate Use | Change in 6-Minute Walk Test (6MWT) | 12 Months | 291.4 Meters | Standard Deviation 142 |
| Compassionate Use | Change in 6-Minute Walk Test (6MWT) | Baseline | 267.4 Meters | Standard Deviation 115.3 |
| Compassionate Use | Change in 6-Minute Walk Test (6MWT) | Difference | 24.0 Meters | Standard Deviation 112.8 |
| Emergency Use | Change in 6-Minute Walk Test (6MWT) | 12 Months | 296.6 Meters | Standard Deviation 129.9 |
| Emergency Use | Change in 6-Minute Walk Test (6MWT) | Baseline | 261.4 Meters | Standard Deviation 142.2 |
| Emergency Use | Change in 6-Minute Walk Test (6MWT) | Difference | 35.2 Meters | Standard Deviation 155.7 |
| High Risk | Change in 6-Minute Walk Test (6MWT) | Baseline | 408.8 Meters | Standard Deviation 380.3 |
| High Risk | Change in 6-Minute Walk Test (6MWT) | Difference | -16.2 Meters | Standard Deviation 339.8 |
| High Risk | Change in 6-Minute Walk Test (6MWT) | 12 Months | 392.6 Meters | Standard Deviation 211.1 |