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, MR, Mitral Valve Prolapse, Edge to Edge (E2E), Alfieri Technique, MitraClip, Functional MR, Degenerative MR, Echocardiogram, CAD - Coronary Artery Disease, Heart Failure, Heart Attack, EVEREST, EVEREST I, EVEREST II, REALISM
Brief summary
EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery. The EVEREST II High Risk Registry (HRR) study is a prospective multi-center study of the MitraClip System for the treatment of mitral valve regurgitation in high surgical risk patients. Enrollment in the RCT and HRR is closed. A continued access prospective, multi-center study (REALISM) of the MitraClip System in a surgical population (non-high risk arm) and a high surgical risk population (high risk arm) is ongoing. Enrollment in the non-high risk arm of REALISM is closed. Enrollment in the high risk arm of REALISM is ongoing. Patients enrolled in EVEREST II undergo 30-day, 6-month, 12-month, 18-month and 24-month clinical and echocardiographic follow-up, and then annually for 5 years.
Detailed description
Prospective, multi-center, randomized 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). A minimum of 279 evaluable patients randomized 2:1 to MitraClip or mitral valve surgery, respectively, are required to test the primary safety and effectiveness endpoints of the RCT. Enrollment in the RCT is now complete. 60 roll-in patients were enrolled under EVEREST II RCT. 38 clinical sites throughout the US and Canada have participated in the RCT and HRR. 37 US sites are participating in REALISM. The RCT is powered to test the hypothesis MitraClip has both superiority of safety and non-inferiority of effectiveness compared to mitral valve repair or replacement surgery. The HRR is powered to show lower mortality at 30 days with the MitraClip than predicted surgical mortality.
Interventions
MitraClip Implant
PROCEDUREMitral valve repair or replacement surgery
Repair or replacement of mitral valve
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion/
Exclusion criteria
Patients with Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation (MR) based on American Society of Echocardiography guidelines: * Are 18 years or older. * Symptomatic * If asymptomatic, must have new onset of atrial fibrillation, pulmonary hypertension, or evidence of left ventricular dysfunction * Are candidates for mitral valve surgery * Are candidates for transseptal catheterization * Primary regurgitant jet must originate from malcoaptation of the A2 and P2 scallops of the mitral valve * Appropriate valve anatomy for MitraClip * Does not need other cardiac surgery or any emergency surgery * Did not experience myocardial infarction in prior 12 weeks or endovascular procedure in prior 30 days * Mitral valve orifice area ≥ 4 cm2 * Do not have renal insufficiency * Echocardiographic evidence of intracardiac mass, thrombus or vegetation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Major Adverse Events (MAE) | 30 days | Defined as a combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastrointestinal (GI) complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood. |
| Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR). | 12 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mitral Valve Area by Planimetry Index | 30 Days | Defined as mitral valve area divided by body surface area as measured by core lab echocardiography. |
| Freedom From All-Cause Mortality | 12 months | — |
| Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation. | 12 months | — |
| Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR). | 24 months | — |
| Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR) in Intention to Treat Strategy Cohort | 24 months | — |
| Left Ventricular Ejection Fraction (LVEF) | At discharge (≤ 14 days following index procedure) or 30 days | LVEF as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer. |
| Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV) | 30 days | Left Ventricular Status includes Left ventricular (LV) end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer. |
| Left Ventricular Status- LVEDV, LVESV | 12 months | Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV),as determined by the core echo laboratory at 12 months. |
| Left Ventricular Internal Dimension Systole (LVIDs) | 30 days | Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory. |
| Left Ventricular Internal Dimension Diastole (LVIDd) | 30 days | Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory. |
| Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | Baseline | 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. |
| New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV | 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. |
| Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV | 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. |
| Short Form (SF)-36 Quality of Life Questionnaire. | 30 days | The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) & mental health status (Mental Component Score) 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. |
| Cardiac Output | 30 days | Cardiac output as measured by core lab echocardiography. |
| Cardiac Index | 30 days | Defined as cardiac output divided by body surface area, as measured by core lab echocardiography. |
| Cardiac Index (CI) | 12 months | Defined as cardiac output divided by body surface area as measured by core lab echocardiography. CI is a normalization of cardiac output to take into account the effect of body size on cardiac output requirements. |
| Regurgitant Volume | 30 Days | Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume. |
| Regurgitant Fraction (RF) | 30 Days | RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium. |
| Regurgitant Fraction | 12 months | Regurgitant fraction is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium. |
| Number of Participants With Clip Implant Rate | Day 0 | Defined as the rate of successful implantation of MitraClip(s). |
| Number of Participants With Successful Clip Implant and Acute Procedural Success | 30 days | Acute procedural success is defined as MR severity ≤ 2 at discharge or 1 grade MR reduction at discharge accompanied by 1 level NYHA reduction. |
| Number of Participants With Mitral Valve Repair Success. | 12 months | Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR \> 2+ at 12 months. |
| Number of Participants With Procedural Freedom From In-hospital MAE. | Day 0 | — |
| Number of Participants With Procedural Freedom From In-hospital MAE | Day 30 | — |
| Number of Participants With MAE: Surgery After Device and First Time Surgery Control | 30 days | — |
| Number of Participants With Major Vascular Complications | 30 days | Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer: * Hematoma at access site \>6 cm; * Retroperitoneal hematoma; * Arteriovenous (AV) fistula; * Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting \>48 hours; * Vascular Surgical Repair at catheter access sites; * Pulmonary embolism; * Ipsilateral deep vein thrombus; or * Access site-related infection requiring intravenous antibiotics and/or extended hospitalization. |
| Number of Participants With Major Bleeding Complications. | 30 days | Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 30 days or hospital discharge, whichever is longer. |
| Number of Participants With Major Adverse Events (MAE) | 12 months. | — |
| Number of Participants With MAE in Patients Over 75 Years of Age. | 30 days | — |
| Number of Participants With Dysrhythmia | 30 days | — |
| Number of Participants With Endocarditis. | 30 days | Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography. |
| Number of Participants With Thrombosis. | 30 days | Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy. |
| Number of Participants With Hemolysis | 30 days | Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below: Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding. Minor: Does not require intervention. |
| 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 Clinically Significant Atrial Septal Defect (ASD) | 12 months | 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 Mitral Valve Stenosis | 30 days | Defined as a mitral valve planimetered orifice area of less than 1.5 cm\^2 as measured by echocardiography. |
| Mitral Valve Area by Planimetry | At Discharge (≤14 days of index procedure) | Mitral valve area as measured by core lab echocardiography. |
| Mitral Valve Area by Pressure Half-time | At Discharge (≤14 days of index procedure) | Mitral valve area as measured by core lab echocardiography. |
| Mitral Valve Area by Pressure Half-time Index | 30 Days | Defined as mitral valve area divided by body surface area as measured by core lab echocardiography. |
| Transvalvular Mitral Valve Gradient | At Discharge (≤ 14 days following index procedure) | Defined as the mean pressure gradient across the mitral valve as measured by echocardiography. |
| Transvalvular Mitral Mean Pressure Gradient (Mean MVG) | 12 months | Defined as the mean pressure gradient across the mitral valve as measured by Echocardiography Core Laboratory (ECL). |
| Post-procedure Length of Hospital Stay | 30 Days | — |
| Post-procedure Intensive Care Unit (ICU) / Critical Care Unit (CCU) Duration | 30 Days | — |
| Number of Participants With Hospital Re-admissions | 30 days | Defined as re-admission to the hospital for any reason. The endpoint was intended to capture each time a patient was re-admitted to the hospital for any reason and was to be reported as a rate through 30 days for both the Device and Control groups. |
| Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility/Hospital | 30 Days | — |
| Number of Participants With Incidence of Hospital Readmissions for Congestive Heart Failure (CHF). | 30 days | — |
| Number of Participants With New Coumadin (Warfarin) Usage | 30 days | — |
| Number of Participants With Durability of the MitraClip Device and Surgery. | 12 months | Device group: Freedom from death, surgery for mitral valve dysfunction and MR \> 2+ at the end of each follow-up interval. Control group: Freedom from death, re-operation for mitral valve dysfunction and MR \> 2+ at the end of each follow-up interval. |
| Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+ | 12 months | Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR \> 2+ |
| Number of Participants With Acute Procedural Success | 30 Days | Defined as successful MitraClip implantation with resulting MR of 2+ or less. |
| Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation | 12 months | Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation |
| Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment | 12 months | Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device. |
| Number of Participants With Non-cerebral Thromboembolism. | 12 months | Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment. |
| Number of Participants With MR Severity | 30 days | MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe. Discharge refers to each individual patient's date of hospital discharge. The discharge date varies for each patient, but in general, discharge occurs before 30-days follow-up. A 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or otherwise uninterpretable. |
| Number of Participants With Incidence of Mitral Valve Replacement | 12 months | — |
| Number of Participants With Freedom From Mitral Valve Surgery/Re-operation | 12 months | Durability estimates: Freedom from Mitral Valve Surgery/Re-operation |
| Number of Participants With Acute Surgical Success | 30 Days | Defined as successful mitral valve repair or replacement surgery. |
Countries
United States
Participant flow
Recruitment details
The EVEREST II RCT was conducted in patients who were indicated for and could undergo mitral valve surgery. A total of 279 patients were enrolled at United States & Canada investigational sites between Aug 5,2005 to Sep 17,2008 time period. The subjects were randomized to Device group (n=184; MitraClip) &Control group (n=95;Mitral Valve Surgery).
Pre-assignment details
The EVEREST II RCT enrolled 279 patients (184 Device and 95 Control), of whom 21 patients (6 Device and 15 Control) did not undergo treatment per their randomized assignment, and are reported as randomized not treated (RNT). All RNT patients except one withdrew from the trial.
Participants by arm
| Arm | Count |
|---|---|
| Device Group (MitraClip Device) Percutaneous mitral valve repair using MitraClip implant. | 184 |
| Control Group (Mitral Valve Surgery) Mitral valve repair or replacement surgery. | 95 |
| Total | 279 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 32 | 15 |
| Overall Study | Missed visit | 3 | 2 |
| Overall Study | Randomized not treated (RNT) | 6 | 15 |
| Overall Study | Withdrawal by Subject | 30 | 15 |
Baseline characteristics
| Characteristic | Device Group (MitraClip Device) | Control Group (Mitral Valve Surgery) | Total |
|---|---|---|---|
| 36-Item Short Form Health Survey (SF-36) Quality of Life (QOL) Mental Component Score | 47.1 scores on a scale STANDARD_DEVIATION 11.9 | 46.6 scores on a scale STANDARD_DEVIATION 12.5 | 46.9 scores on a scale STANDARD_DEVIATION 12 |
| 36-Item Short Form Health Survey (SF-36) Quality of Life (QOL) Physical Component Score | 41.1 scores on a scale STANDARD_DEVIATION 10 | 41.9 scores on a scale STANDARD_DEVIATION 11.1 | 41.4 scores on a scale STANDARD_DEVIATION 10.3 |
| Age, Continuous | 67.3 years STANDARD_DEVIATION 12.8 | 65.7 years STANDARD_DEVIATION 12.9 | 66.7 years STANDARD_DEVIATION 12.8 |
| Age, Customized 18-75 years | 129 Participants | 69 Participants | 198 Participants |
| Age, Customized >75 years | 55 Participants | 26 Participants | 81 Participants |
| Left Ventricular (LV) Measurement LV End Diastolic Volume (LVEDV) | 156.5 mL STANDARD_DEVIATION 39 | 159.6 mL STANDARD_DEVIATION 46.3 | 158.05 mL STANDARD_DEVIATION 42.65 |
| Left Ventricular (LV) Measurement LV End Systolic Volume (LVESV) | 63.5 mL STANDARD_DEVIATION 25.5 | 63.8 mL STANDARD_DEVIATION 28.9 | 63.65 mL STANDARD_DEVIATION 27.2 |
| Left Ventricular (LV) Measurement LV internal dimension diastole (LVIDd) | 5.5 cm STANDARD_DEVIATION 0.7 | 5.5 cm STANDARD_DEVIATION 0.7 | 5.5 cm STANDARD_DEVIATION 0.7 |
| Left Ventricular (LV) Measurement LV internal dimension systole (LVIDs) | 3.7 cm STANDARD_DEVIATION 0.9 | 3.5 cm STANDARD_DEVIATION 0.8 | 3.6 cm STANDARD_DEVIATION 0.85 |
| Mitral regurgitation (MR) 0: None | 0 Participants | 0 Participants | 0 Participants |
| Mitral regurgitation (MR) 1+: Mild | 0 Participants | 0 Participants | 0 Participants |
| Mitral regurgitation (MR) 2+: Moderate | 8 Participants | 7 Participants | 15 Participants |
| Mitral regurgitation (MR) 3+: Moderate-to-Severe | 130 Participants | 67 Participants | 197 Participants |
| Mitral regurgitation (MR) 4+: Severe | 46 Participants | 21 Participants | 67 Participants |
| NYHA Functional Class NYHA Functional Class I | 17 Participants | 19 Participants | 36 Participants |
| NYHA Functional Class NYHA Functional Class II | 73 Participants | 31 Participants | 104 Participants |
| NYHA Functional Class NYHA Functional Class III | 82 Participants | 41 Participants | 123 Participants |
| NYHA Functional Class NYHA Functional Class IV | 12 Participants | 4 Participants | 16 Participants |
| Region of Enrollment Canada | 7 Participants | 2 Participants | 9 Participants |
| Region of Enrollment United States | 177 Participants | 93 Participants | 270 Participants |
| Sex: Female, Male Female | 69 Participants | 32 Participants | 101 Participants |
| Sex: Female, Male Male | 115 Participants | 63 Participants | 178 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 20 / 178 | 9 / 80 |
| other Total, other adverse events | 168 / 178 | 80 / 80 |
| serious Total, serious adverse events | 127 / 178 | 54 / 80 |
Outcome results
Primary
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).
Time frame: 12 months
Population: Per-protocol cohort. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR). | 97 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR). | 65 Participants |
Primary
Number of Participants With Major Adverse Events (MAE)
Defined as a combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, gastrointestinal (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: Per-protocol cohort. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Major Adverse Events (MAE) | 13 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Major Adverse Events (MAE) | 45 Participants |
Secondary
Cardiac Index
Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.
Time frame: 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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Cardiac Index | 2.2 L/min/m^2 | Standard Deviation 0.6 |
| Control Group (Mitral Valve Surgery) | Cardiac Index | 2.5 L/min/m^2 | Standard Deviation 0.6 |
Secondary
Cardiac Index
Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.
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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Cardiac Index | 2.1 L/min/m^2 | Standard Deviation 0.5 |
| Control Group (Mitral Valve Surgery) | Cardiac Index | 2.1 L/min/m^2 | Standard Deviation 0.5 |
Secondary
Cardiac Index (CI)
Defined as cardiac output divided by body surface area as measured by core lab echocardiography. CI is a normalization of cardiac output to take into account the effect of body size on cardiac output requirements.
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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Cardiac Index (CI) | 2.3 L/min/m^2 | Standard Deviation 0.6 |
| Control Group (Mitral Valve Surgery) | Cardiac Index (CI) | 2.4 L/min/m^2 | Standard Deviation 0.6 |
Secondary
Cardiac Output
Cardiac output as measured by core lab echocardiography.
Time frame: 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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Cardiac Output | 4.2 L/min | Standard Deviation 1.2 |
| Control Group (Mitral Valve Surgery) | Cardiac Output | 4.8 L/min | Standard Deviation 1.3 |
Secondary
Cardiac Output
Cardiac output as measured by core lab echocardiography.
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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Cardiac Output | 4.4 L/min | Standard Deviation 1.3 |
| Control Group (Mitral Valve Surgery) | Cardiac Output | 4.6 L/min | Standard Deviation 1.4 |
Secondary
Cardiac Output
Cardiac output as measured by core lab echocardiography.
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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Cardiac Output | 4.0 L/min | Standard Deviation 1.1 |
| Control Group (Mitral Valve Surgery) | Cardiac Output | 4.1 L/min | Standard Deviation 1.1 |
Secondary
Freedom From All-Cause Mortality
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 (NUMBER) |
|---|---|---|
| Device Group (MitraClip Device) | Freedom From All-Cause Mortality | 90.0 Percentage of participants |
| Control Group (Mitral Valve Surgery) | Freedom From All-Cause Mortality | 89.6 Percentage of participants |
Secondary
Freedom From All-Cause Mortality
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 (NUMBER) |
|---|---|---|
| Device Group (MitraClip Device) | Freedom From All-Cause Mortality | 93.7 Percentage of participants |
| Control Group (Mitral Valve Surgery) | Freedom From All-Cause Mortality | 92.3 Percentage of participants |
Secondary
Freedom From All-Cause Mortality
Time frame: 3 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device Group (MitraClip Device) | Freedom From All-Cause Mortality | 87.5 Percentage of participants |
| Control Group (Mitral Valve Surgery) | Freedom From All-Cause Mortality | 85.3 Percentage of participants |
Secondary
Freedom From All-Cause Mortality
Time frame: 4 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device Group (MitraClip Device) | Freedom From All-Cause Mortality | 83.4 Percentage of participants |
| Control Group (Mitral Valve Surgery) | Freedom From All-Cause Mortality | 82.3 Percentage of participants |
Secondary
Freedom From All-Cause Mortality
Time frame: 5 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device Group (MitraClip Device) | Freedom From All-Cause Mortality | 81.2 Percentage of participants |
| Control Group (Mitral Valve Surgery) | Freedom From All-Cause Mortality | 79 Percentage of participants |
Secondary
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo 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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Ejection Fraction (LVEF) | 56.9 Percentage of volume ejected | Standard Deviation 8.3 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Ejection Fraction (LVEF) | 55.8 Percentage of volume ejected | Standard Deviation 8.1 |
Secondary
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory.
Time frame: 3 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Ejection Fraction (LVEF) | 57.0 Percentage of volume ejected | Standard Deviation 9.1 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Ejection Fraction (LVEF) | 58.4 Percentage of volume ejected | Standard Deviation 9.2 |
Secondary
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory.
Time frame: 4 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Ejection Fraction (LVEF) | 57.6 Percentage of volume ejected | Standard Deviation 9.9 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Ejection Fraction (LVEF) | 58.9 Percentage of volume ejected | Standard Deviation 10.2 |
Secondary
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory.
Time frame: 5 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Ejection Fraction (LVEF) | 56.5 Percentage of volume ejected | Standard Deviation 10.1 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Ejection Fraction (LVEF) | 57 Percentage of volume ejected | Standard Deviation 9.3 |
Secondary
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.
Time frame: At discharge (≤ 14 days following 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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Ejection Fraction (LVEF) | 56.9 Percentage of volume ejected | Standard Deviation 10 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Ejection Fraction (LVEF) | 53.9 Percentage of volume ejected | Standard Deviation 10.9 |
Secondary
Left Ventricular Ejection Fraction (LVEF)
LVEF as determined by the core echo 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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Ejection Fraction (LVEF) | 58.0 Percentage of volume ejected | Standard Deviation 8.7 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Ejection Fraction (LVEF) | 55.3 Percentage of volume ejected | Standard Deviation 10.2 |
Secondary
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 24 months.
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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.0 cm | Standard Deviation 0.7 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Internal Dimension Diastole (LVIDd) | 4.7 cm | Standard Deviation 0.8 |
Secondary
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 4 years.
Time frame: 4 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.3 cm | Standard Deviation 0.6 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Internal Dimension Diastole (LVIDd) | 4.8 cm | Standard Deviation 0.7 |
Secondary
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 5 years.
Time frame: 5 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.2 cm | Standard Deviation 0.6 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Internal Dimension Diastole (LVIDd) | 4.9 cm | Standard Deviation 0.7 |
Secondary
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory.
Time frame: 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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.3 cm | Standard Deviation 0.7 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.0 cm | Standard Deviation 0.7 |
Secondary
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 12 months.
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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.1 cm | Standard Deviation 0.7 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Internal Dimension Diastole (LVIDd) | 4.8 cm | Standard Deviation 0.7 |
Secondary
Left Ventricular Internal Dimension Diastole (LVIDd)
Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 3 years.
Time frame: 3 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Internal Dimension Diastole (LVIDd) | 5.2 cm | Standard Deviation 0.7 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Internal Dimension Diastole (LVIDd) | 4.8 cm | Standard Deviation 0.7 |
Secondary
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time frame: 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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Internal Dimension Systole (LVIDs) | 3.6 cm | Standard Deviation 0.9 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Internal Dimension Systole (LVIDs) | 3.5 cm | Standard Deviation 0.8 |
Secondary
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time frame: 3 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Internal Dimension Systole (LVIDs) | 3.6 cm | Standard Deviation 0.9 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Internal Dimension Systole (LVIDs) | 3.2 cm | Standard Deviation 0.8 |
Secondary
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time frame: 4 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Internal Dimension Systole (LVIDs) | 3.6 cm | Standard Deviation 0.9 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Internal Dimension Systole (LVIDs) | 3.3 cm | Standard Deviation 0.8 |
Secondary
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time frame: 5 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Internal Dimension Systole (LVIDs) | 3.6 cm | Standard Deviation 0.9 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Internal Dimension Systole (LVIDs) | 3.3 cm | Standard Deviation 0.9 |
Secondary
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time frame: 2 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Internal Dimension Systole (LVIDs) | 3.4 cm | Standard Deviation 0.8 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Internal Dimension Systole (LVIDs) | 3.2 cm | Standard Deviation 0.9 |
Secondary
Left Ventricular Internal Dimension Systole (LVIDs)
Left Ventricular internal dimension systole (LVIDs) as determined by the core echo 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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Internal Dimension Systole (LVIDs) | 3.5 cm | Standard Deviation 0.8 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Internal Dimension Systole (LVIDs) | 3.3 cm | Standard Deviation 0.8 |
Secondary
Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV)
Left Ventricular Status includes Left ventricular (LV) end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 30 days or hospital discharge, whichever is longer.
Time frame: 30 days
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV) | LVEDV | 144.7 ml | Standard Deviation 40 |
| Device Group (MitraClip Device) | Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV) | LVESV | 63.7 ml | Standard Deviation 27.2 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV) | LVESV | 62.0 ml | Standard Deviation 29.2 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV) | LVEDV | 130.8 ml | Standard Deviation 40.5 |
Secondary
Left Ventricular Status- LVEDV, LVESV
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 4 years
Time frame: 4 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Status- LVEDV, LVESV | LVEDV | 126.6 ml | Standard Deviation 33.1 |
| Device Group (MitraClip Device) | Left Ventricular Status- LVEDV, LVESV | LVESV | 55.0 ml | Standard Deviation 24.4 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Status- LVEDV, LVESV | LVEDV | 112.7 ml | Standard Deviation 40.4 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Status- LVEDV, LVESV | LVESV | 48.1 ml | Standard Deviation 26.9 |
Secondary
Left Ventricular Status- LVEDV, LVESV
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV),as determined by the core echo laboratory at 12 months.
Time frame: 12 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Status- LVEDV, LVESV | LVEDV | 133.7 ml | Standard Deviation 35.5 |
| Device Group (MitraClip Device) | Left Ventricular Status- LVEDV, LVESV | LVESV | 57.5 ml | Standard Deviation 24 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Status- LVEDV, LVESV | LVESV | 56.2 ml | Standard Deviation 31.4 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Status- LVEDV, LVESV | LVEDV | 120.9 ml | Standard Deviation 44.3 |
Secondary
Left Ventricular Status- LVEDV, LVESV
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 24 months.
Time frame: 24 months
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Status- LVEDV, LVESV | LVEDV | 123.4 mL | Standard Deviation 35 |
| Device Group (MitraClip Device) | Left Ventricular Status- LVEDV, LVESV | LVESV | 54.7 mL | Standard Deviation 24.7 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Status- LVEDV, LVESV | LVESV | 50.4 mL | Standard Deviation 26.3 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Status- LVEDV, LVESV | LVEDV | 110.5 mL | Standard Deviation 40.9 |
Secondary
Left Ventricular Status- LVEDV, LVESV
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 3 years.
Time frame: 3 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Status- LVEDV, LVESV | LVEDV | 130.6 ml | Standard Deviation 32.6 |
| Device Group (MitraClip Device) | Left Ventricular Status- LVEDV, LVESV | LVESV | 57.7 ml | Standard Deviation 24.7 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Status- LVEDV, LVESV | LVEDV | 112.7 ml | Standard Deviation 40.2 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Status- LVEDV, LVESV | LVESV | 48.0 ml | Standard Deviation 24.7 |
Secondary
Left Ventricular Status- LVEDV, LVESV
Left Ventricular Status includes LV end-diastolic volume (LVEDV), LV end-systolic volume (LVESV), as determined by the core echo laboratory at 5 years.
Time frame: 5 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device Group (MitraClip Device) | Left Ventricular Status- LVEDV, LVESV | LVEDV | 126.3 ml | Standard Deviation 32.5 |
| Device Group (MitraClip Device) | Left Ventricular Status- LVEDV, LVESV | LVESV | 56.1 ml | Standard Deviation 23 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Status- LVEDV, LVESV | LVEDV | 112.9 ml | Standard Deviation 37.8 |
| Control Group (Mitral Valve Surgery) | Left Ventricular Status- LVEDV, LVESV | LVESV | 50.1 ml | Standard Deviation 26.3 |
Secondary
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Time frame: 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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Mitral Valve Area by Planimetry | 3.6 cm^2 | Standard Deviation 1.1 |
| Control Group (Mitral Valve Surgery) | Mitral Valve Area by Planimetry | 3.9 cm^2 | Standard Deviation 1.2 |
Secondary
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Time frame: 4 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group (MitraClip Device) | Mitral Valve Area by Planimetry | 3.2 cm^2 | Standard Deviation 0.9 |
| Control Group (Mitral Valve Surgery) | Mitral Valve Area by Planimetry | 3.8 cm^2 | Standard Deviation 0.8 |
Secondary
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Mitral Valve Area by Planimetry | 3.3 cm^2 | Standard Deviation 0.9 |
| Control Group (Mitral Valve Surgery) | Mitral Valve Area by Planimetry | 3.3 cm^2 | Standard Deviation 0.8 |
Secondary
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Mitral Valve Area by Planimetry | 3.2 cm^2 | Standard Deviation 1 |
| Control Group (Mitral Valve Surgery) | Mitral Valve Area by Planimetry | 3.7 cm^2 | Standard Deviation 1.1 |
Secondary
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Time frame: 3 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group (MitraClip Device) | Mitral Valve Area by Planimetry | 3.3 cm^2 | Standard Deviation 0.9 |
| Control Group (Mitral Valve Surgery) | Mitral Valve Area by Planimetry | 3.6 cm^2 | Standard Deviation 0.9 |
Secondary
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Time frame: At Discharge (≤14 days 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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Mitral Valve Area by Planimetry | 3.7 cm^2 | Standard Deviation 1.4 |
| Control Group (Mitral Valve Surgery) | Mitral Valve Area by Planimetry | 3.6 cm^2 | Standard Deviation 0.9 |
Secondary
Mitral Valve Area by Planimetry
Mitral valve area as measured by core lab echocardiography.
Time frame: 5 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group (MitraClip Device) | Mitral Valve Area by Planimetry | 3.2 cm^2 | Standard Deviation 1 |
| Control Group (Mitral Valve Surgery) | Mitral Valve Area by Planimetry | 3.7 cm^2 | Standard Deviation 1 |
Secondary
Mitral Valve Area by Planimetry Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Mitral Valve Area by Planimetry Index | 1.7 cm^2/m^2 | Standard Deviation 0.5 |
| Control Group (Mitral Valve Surgery) | Mitral Valve Area by Planimetry Index | 1.9 cm^2/m^2 | Standard Deviation 0.6 |
Secondary
Mitral Valve Area by Planimetry Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Mitral Valve Area by Planimetry Index | 1.7 cm^2/m^2 | Standard Deviation 0.4 |
| Control Group (Mitral Valve Surgery) | Mitral Valve Area by Planimetry Index | 1.8 cm^2/m^2 | Standard Deviation 0.6 |
Secondary
Mitral Valve Area by Planimetry Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Time frame: 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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Mitral Valve Area by Planimetry Index | 1.9 cm^2/m^2 | Standard Deviation 0.6 |
| Control Group (Mitral Valve Surgery) | Mitral Valve Area by Planimetry Index | 2.0 cm^2/m^2 | Standard Deviation 0.5 |
Secondary
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Time frame: 3 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group (MitraClip Device) | Mitral Valve Area by Pressure Half-time | 2.7 cm^2 | Standard Deviation 0.7 |
| Control Group (Mitral Valve Surgery) | Mitral Valve Area by Pressure Half-time | 2.8 cm^2 | Standard Deviation 0.6 |
Secondary
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Time frame: 5 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group (MitraClip Device) | Mitral Valve Area by Pressure Half-time | 2.7 cm^2 | Standard Deviation 0.7 |
| Control Group (Mitral Valve Surgery) | Mitral Valve Area by Pressure Half-time | 2.8 cm^2 | Standard Deviation 0.7 |
Secondary
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Time frame: 4 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group (MitraClip Device) | Mitral Valve Area by Pressure Half-time | 2.9 cm^2 | Standard Deviation 0.8 |
| Control Group (Mitral Valve Surgery) | Mitral Valve Area by Pressure Half-time | 3.0 cm^2 | Standard Deviation 1 |
Secondary
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Mitral Valve Area by Pressure Half-time | 2.7 cm^2 | Standard Deviation 0.7 |
| Control Group (Mitral Valve Surgery) | Mitral Valve Area by Pressure Half-time | 2.8 cm^2 | Standard Deviation 0.7 |
Secondary
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Mitral Valve Area by Pressure Half-time | 2.9 cm^2 | Standard Deviation 1 |
| Control Group (Mitral Valve Surgery) | Mitral Valve Area by Pressure Half-time | 3.1 cm^2 | Standard Deviation 1.1 |
Secondary
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Time frame: 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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Mitral Valve Area by Pressure Half-time | 2.8 cm^2 | Standard Deviation 1 |
| Control Group (Mitral Valve Surgery) | Mitral Valve Area by Pressure Half-time | 3.5 cm^2 | Standard Deviation 1.2 |
Secondary
Mitral Valve Area by Pressure Half-time
Mitral valve area as measured by core lab echocardiography.
Time frame: At Discharge (≤14 days 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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Mitral Valve Area by Pressure Half-time | 3.0 cm^2 | Standard Deviation 1.1 |
| Control Group (Mitral Valve Surgery) | Mitral Valve Area by Pressure Half-time | 3.3 cm^2 | Standard Deviation 1.1 |
Secondary
Mitral Valve Area by Pressure Half-time Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Mitral Valve Area by Pressure Half-time Index | 1.4 cm^2/m^2 | Standard Deviation 0.4 |
| Control Group (Mitral Valve Surgery) | Mitral Valve Area by Pressure Half-time Index | 1.5 cm^2/m^2 | Standard Deviation 0.5 |
Secondary
Mitral Valve Area by Pressure Half-time Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
Time frame: 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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Mitral Valve Area by Pressure Half-time Index | 1.5 cm^2/m^2 | Standard Deviation 0.6 |
| Control Group (Mitral Valve Surgery) | Mitral Valve Area by Pressure Half-time Index | 1.9 cm^2/m^2 | Standard Deviation 0.7 |
Secondary
Mitral Valve Area by Pressure Half-time Index
Defined as mitral valve area divided by body surface area as measured by core lab echocardiography.
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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Mitral Valve Area by Pressure Half-time Index | 1.5 cm^2/m^2 | Standard Deviation 0.6 |
| Control Group (Mitral Valve Surgery) | Mitral Valve Area by Pressure Half-time Index | 1.7 cm^2/m^2 | Standard Deviation 0.7 |
Secondary
New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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 | Value (NUMBER) |
|---|---|---|
| Device Group (MitraClip Device) | New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV | 10.1 Percentage of participants |
| Control Group (Mitral Valve Surgery) | New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV | 9.3 Percentage of participants |
Secondary
Number of Participants With Acute Procedural Success
Defined as successful MitraClip implantation with resulting MR of 2+ or less.
Time frame: 30 Days
Population: ITT population. The number of participants analyzed in Device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Acute Procedural Success | 137 Participants |
Secondary
Number of Participants With Acute Surgical Success
Defined as successful mitral valve repair or replacement surgery.
Time frame: 30 Days
Population: The number of participants analyzed in control group includes subjects who had available follow up data at that time frame. Not applicable for Device group patients as device was not implanted. The population includes all patients who underwent the index surgical procedure and excludes 15 patients who were randomized, but not treated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group (Mitral Valve Surgery) | Number of Participants With Acute Surgical Success | 80 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) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Clinically Significant Atrial Septal Defect (ASD) | 4 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Clinically Significant Atrial Septal Defect (ASD) | 0 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) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Clinically Significant Atrial Septal Defect (ASD). | 2 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Clinically Significant Atrial Septal Defect (ASD). | 0 Participants |
Secondary
Number of Participants With Clip Implant Rate
Defined as the rate of successful implantation of MitraClip(s).
Time frame: Day 0
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame. MitraClip was not implanted in control group, hence overall number of patients analyzed will remain 0.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Clip Implant Rate | 158 Participants |
Secondary
Number of Participants With Durability of the MitraClip Device and Surgery.
Device group: Freedom from death, surgery for mitral valve dysfunction and MR \> 2+ at the end of each follow-up interval. Control group: Freedom from death, re-operation for mitral valve dysfunction and MR \> 2+ at the end of each follow-up interval.
Time frame: 24 months-3 year
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) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Durability of the MitraClip Device and Surgery. | Deaths | 0 Participants |
| Device Group (MitraClip Device) | Number of Participants With Durability of the MitraClip Device and Surgery. | Surgeries | 0 Participants |
| Device Group (MitraClip Device) | Number of Participants With Durability of the MitraClip Device and Surgery. | Patients with MR > 2+ | 4 Participants |
| Device Group (MitraClip Device) | Number of Participants With Durability of the MitraClip Device and Surgery. | Withdrawn/ Censored | 52 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Durability of the MitraClip Device and Surgery. | Withdrawn/ Censored | 32 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Durability of the MitraClip Device and Surgery. | Deaths | 2 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Durability of the MitraClip Device and Surgery. | Patients with MR > 2+ | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Durability of the MitraClip Device and Surgery. | Surgeries | 1 Participants |
Secondary
Number of Participants With Durability of the MitraClip Device and Surgery.
Device group: Freedom from death, surgery for mitral valve dysfunction and MR \> 2+ at the end of each follow-up interval. Control group: Freedom from death, re-operation for mitral valve dysfunction and MR \> 2+ at the end of each follow-up interval.
Time frame: 12 months
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) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Durability of the MitraClip Device and Surgery. | Deaths | 6 Participants |
| Device Group (MitraClip Device) | Number of Participants With Durability of the MitraClip Device and Surgery. | Patients with MR > 2+ | 22 Participants |
| Device Group (MitraClip Device) | Number of Participants With Durability of the MitraClip Device and Surgery. | Withdrawn/ Censored | 3 Participants |
| Device Group (MitraClip Device) | Number of Participants With Durability of the MitraClip Device and Surgery. | Surgeries | 9 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Durability of the MitraClip Device and Surgery. | Surgeries | 2 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Durability of the MitraClip Device and Surgery. | Deaths | 5 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Durability of the MitraClip Device and Surgery. | Withdrawn/ Censored | 6 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Durability of the MitraClip Device and Surgery. | Patients with MR > 2+ | 2 Participants |
Secondary
Number of Participants With Durability of the MitraClip Device and Surgery.
Device group: Freedom from death, surgery for mitral valve dysfunction and MR \> 2+ at the end of each follow-up interval. Control group: Freedom from death, re-operation for mitral valve dysfunction and MR \> 2+ at the end of each follow-up interval.
Time frame: 18-24 months
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) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Durability of the MitraClip Device and Surgery. | Patients with MR > 2+ | 3 Participants |
| Device Group (MitraClip Device) | Number of Participants With Durability of the MitraClip Device and Surgery. | Withdrawn/ Censored | 19 Participants |
| Device Group (MitraClip Device) | Number of Participants With Durability of the MitraClip Device and Surgery. | Deaths | 0 Participants |
| Device Group (MitraClip Device) | Number of Participants With Durability of the MitraClip Device and Surgery. | Surgeries | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Durability of the MitraClip Device and Surgery. | Surgeries | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Durability of the MitraClip Device and Surgery. | Patients with MR > 2+ | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Durability of the MitraClip Device and Surgery. | Deaths | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Durability of the MitraClip Device and Surgery. | Withdrawn/ Censored | 12 Participants |
Secondary
Number of Participants With Durability of the MitraClip Device and Surgery.
Device group: Freedom from death, surgery for mitral valve dysfunction and MR \> 2+ at the end of each follow-up interval. Control group: Freedom from death, re-operation for mitral valve dysfunction and MR \> 2+ at the end of each follow-up interval.
Time frame: 12-18 months
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) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Durability of the MitraClip Device and Surgery. | Deaths | 0 Participants |
| Device Group (MitraClip Device) | Number of Participants With Durability of the MitraClip Device and Surgery. | Surgeries | 0 Participants |
| Device Group (MitraClip Device) | Number of Participants With Durability of the MitraClip Device and Surgery. | Patients with MR > 2+ | 4 Participants |
| Device Group (MitraClip Device) | Number of Participants With Durability of the MitraClip Device and Surgery. | Withdrawn/ Censored | 29 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Durability of the MitraClip Device and Surgery. | Withdrawn/ Censored | 25 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Durability of the MitraClip Device and Surgery. | Deaths | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Durability of the MitraClip Device and Surgery. | Patients with MR > 2+ | 2 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Durability of the MitraClip Device and Surgery. | Surgeries | 1 Participants |
Secondary
Number of Participants With Dysrhythmia
Time frame: 30 days
Population: ITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Dysrhythmia | 9 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Dysrhythmia | 22 Participants |
Secondary
Number of Participants With Dysrhythmia
Time frame: 12 months
Population: ITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Dysrhythmia | 22 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Dysrhythmia | 22 Participants |
Secondary
Number of Participants With Endocarditis.
Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.
Time frame: 12 months
Population: ITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Endocarditis. | 2 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Endocarditis. | 1 Participants |
Secondary
Number of Participants With Endocarditis.
Defined as a diagnosis of endocarditis based on the Duke criteria. Infection in the lining of the heart, of the valves, or of the muscles of the heart. Signs of endocarditis may include persistent positive blood cultures and/or valvular structural abnormality and vegetations as seen using echocardiography.
Time frame: 30 days
Population: ITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Endocarditis. | 1 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Endocarditis. | 1 Participants |
Secondary
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Time frame: 4 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) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation | 116 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation | 64 Participants |
Secondary
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Time frame: 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) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation | 111 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation | 61 Participants |
Secondary
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation | 133 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation | 73 Participants |
Secondary
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation | 127 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation | 70 Participants |
Secondary
Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Death and Mitral Valve Surgery/Re-operation
Time frame: 3 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) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation | 122 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Freedom From Death and Mitral Valve Surgery/Re-operation | 66 Participants |
Secondary
Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+
Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR \> 2+
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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+ | 101 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+ | 66 Participants |
Secondary
Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+
Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR \> 2+
Time frame: 3 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) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+ | 96 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+ | 62 Participants |
Secondary
Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+
Durability estimates: Freedom from Death, Mitral Valve Surgery/Re-operation and MR \> 2+
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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+ | 110 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Freedom From Death, Mitral Valve Surgery/Re-operation and MR > 2+ | 71 Participants |
Secondary
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Time frame: 4 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) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Freedom From Mitral Valve Surgery/Re-operation | 137 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Freedom From Mitral Valve Surgery/Re-operation | 76 Participants |
Secondary
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Time frame: 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) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Freedom From Mitral Valve Surgery/Re-operation | 135 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Freedom From Mitral Valve Surgery/Re-operation | 75 Participants |
Secondary
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Freedom From Mitral Valve Surgery/Re-operation | 141 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Freedom From Mitral Valve Surgery/Re-operation | 78 Participants |
Secondary
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Freedom From Mitral Valve Surgery/Re-operation | 140 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Freedom From Mitral Valve Surgery/Re-operation | 77 Participants |
Secondary
Number of Participants With Freedom From Mitral Valve Surgery/Re-operation
Durability estimates: Freedom from Mitral Valve Surgery/Re-operation
Time frame: 3 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) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Freedom From Mitral Valve Surgery/Re-operation | 139 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Freedom From Mitral Valve Surgery/Re-operation | 76 Participants |
Secondary
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation.
Time frame: 12 months
Population: Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation. | 118 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation. | 65 Participants |
Secondary
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).
Time frame: 24 months
Population: Per-protocol population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR). | 87 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR). | 55 Participants |
Secondary
Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR) in Intention to Treat Strategy Cohort
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 (NUMBER) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR) in Intention to Treat Strategy Cohort | 100 participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR) in Intention to Treat Strategy Cohort | 56 participants |
Secondary
Number of Participants With Hemolysis
Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below: Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding. Minor: Does not require intervention.
Time frame: 30 days
Population: ITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Hemolysis | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Hemolysis | 0 Participants |
Secondary
Number of Participants With Hemolysis
Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on repeat measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms. Reported as major or minor as defined below: Major: Requires intervention with red blood cell transfusion or other hematocrit increasing measures in the absence of other obvious bleeding. Minor: Does not require intervention.
Time frame: 12 months
Population: ITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Hemolysis | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Hemolysis | 0 Participants |
Secondary
Number of Participants With Hospital Re-admissions
Defined as re-admission to the hospital for any reason. The endpoint was intended to capture each time a patient was re-admitted to the hospital for any reason and was to be reported as a rate through 30 days for both the Device and Control groups.
Time frame: 30 days
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Hospital Re-admissions | 24 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Hospital Re-admissions | 14 Participants |
Secondary
Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility/Hospital
Time frame: 30 Days
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility/Hospital | 6 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Incidence of Discharge to a Nursing Home or Skilled Nursing Facility/Hospital | 12 Participants |
Secondary
Number of Participants With Incidence of Hospital Readmissions for Congestive Heart Failure (CHF).
Time frame: 30 days
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Incidence of Hospital Readmissions for Congestive Heart Failure (CHF). | 2 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Incidence of Hospital Readmissions for Congestive Heart Failure (CHF). | 2 Participants |
Secondary
Number of Participants With Incidence of Mitral Valve Replacement
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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Incidence of Mitral Valve Replacement | 17 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Incidence of Mitral Valve Replacement | 14 Participants |
Secondary
Number of Participants With Incidence of Mitral Valve Replacement
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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Incidence of Mitral Valve Replacement | 17 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Incidence of Mitral Valve Replacement | 11 Participants |
Secondary
Number of Participants With MAE in Patients Over 75 Years of Age.
Time frame: 30 days
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With MAE in Patients Over 75 Years of Age. | 9 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MAE in Patients Over 75 Years of Age. | 12 Participants |
Secondary
Number of Participants With MAE in Patients Over 75 Years of Age.
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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With MAE in Patients Over 75 Years of Age. | 14 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MAE in Patients Over 75 Years of Age. | 14 Participants |
Secondary
Number of Participants With MAE: Surgery After Device and First Time Surgery Control
Time frame: 30 days
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With MAE: Surgery After Device and First Time Surgery Control | 14 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MAE: Surgery After Device and First Time Surgery Control | 40 Participants |
Secondary
Number of Participants With Major Adverse Events (MAE)
Time frame: 12 months.
Population: Intent to treat (ITT) population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Major Adverse Events (MAE) | 39 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Major Adverse Events (MAE) | 44 Participants |
Secondary
Number of Participants With Major Bleeding Complications.
Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 30 days or hospital discharge, whichever is longer.
Time frame: 30 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Major Bleeding Complications. | 9 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Major Bleeding Complications. | 38 Participants |
Secondary
Number of Participants With Major Bleeding Complications.
Major Bleeding Complications defined as procedure related bleeding that requires a transfusion of ≥2 units of blood products and/or surgical intervention at 12 months.
Time frame: 12 months
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Major Bleeding Complications. | 17 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Major Bleeding Complications. | 39 Participants |
Secondary
Number of Participants With Major Vascular Complications
Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer: * Hematoma at access site \>6 cm; * Retroperitoneal hematoma; * Arteriovenous (AV) fistula; * Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting \>48 hours; * Vascular Surgical Repair at catheter access sites; * Pulmonary embolism; * Ipsilateral deep vein thrombus; or * Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.
Time frame: 30 days
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Major Vascular Complications | 9 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Major Vascular Complications | 0 Participants |
Secondary
Number of Participants With Major Vascular Complications
Vascular Complications defined as the occurrence of any of the following resulting through 30 days or hospital discharge, whichever is longer: * Hematoma at access site \>6 cm; * Retroperitoneal hematoma; * Arteriovenous (AV) fistula; * Symptomatic peripheral ischemia / nerve injury or the clinical signs or symptoms lasting \>48 hours; * Vascular Surgical Repair at catheter access sites; * Pulmonary embolism; * Ipsilateral deep vein thrombus; or * Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.
Time frame: 12 months
Population: ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Major Vascular Complications | 11 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Major Vascular Complications | 0 Participants |
Secondary
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device.
Time frame: 12 months
Population: The number of participants analyzed in device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment | Device Embolization | 0 Participants |
| Device Group (MitraClip Device) | Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment | Single Leaflet Device Attachment | 10 Participants |
Secondary
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device
Time frame: 12 months to 5 years
Population: The number of participants analyzed in device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment | Device Embolization | 0 Participants |
| Device Group (MitraClip Device) | Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment | Single Leaflet Device Attachment | 0 Participants |
Secondary
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device
Time frame: 12 months to 4 years
Population: The number of participants analyzed in device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment | Device Embolization | 0 Participants |
| Device Group (MitraClip Device) | Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment | Single Leaflet Device Attachment | 0 Participants |
Secondary
Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment
Device Embolization is defined as the complete detachment of the MitraClip Device from one or both mitral leaflets. Single leaflet device attachment (SLDA) is defined as attachment of one mitral valve leaflet to the MitraClip device. The control group did not receive the MitraClip device
Time frame: 12 months to 3 years
Population: The number of participants analyzed in device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment | Device Embolization | 0 Participants |
| Device Group (MitraClip Device) | Number of Participants With MitraClip Device Embolization/Single Leaflet Device Attachment | Single Leaflet Device Attachment | 0 Participants |
Secondary
Number of Participants With Mitral Valve Repair Success.
Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR \> 2+ at 12 months.
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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Mitral Valve Repair Success. | 114 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Mitral Valve Repair Success. | 57 Participants |
Secondary
Number of Participants With Mitral Valve Repair Success.
Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR \> 2+ at 12 months.
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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Mitral Valve Repair Success. | 103 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Mitral Valve Repair Success. | 46 Participants |
Secondary
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm\^2 as measured by echocardiography. A confirmed case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area \< 1.5 cm\^2. A conservative case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.
Time frame: 3 years
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) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Mitral Valve Stenosis | Conservative cases | 3 Participants |
| Device Group (MitraClip Device) | Number of Participants With Mitral Valve Stenosis | Confirmed cases | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Mitral Valve Stenosis | Conservative cases | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Mitral Valve Stenosis | Confirmed cases | 0 Participants |
Secondary
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm\^2 as measured by echocardiography. A confirmed case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area \< 1.5 cm\^2. A conservative case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.
Time frame: 5 years
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) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Mitral Valve Stenosis | Confirmed cases | 1 Participants |
| Device Group (MitraClip Device) | Number of Participants With Mitral Valve Stenosis | Conservative cases | 4 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Mitral Valve Stenosis | Confirmed cases | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Mitral Valve Stenosis | Conservative cases | 2 Participants |
Secondary
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve (MV) planimetered orifice area of less than 1.5 cm\^2 as measured by echocardiography. A confirmed case of MV stenosis is defined as Echocardiography Core Lab (ECL) measured mitral valve orifice area \< 1.5 cm\^2. A conservative case of MV stenosis is defined as stenosis suspected by the site, based on hemodynamic measurements or clinical symptoms.
Time frame: 4 years
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) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Mitral Valve Stenosis | Conservative cases | 3 Participants |
| Device Group (MitraClip Device) | Number of Participants With Mitral Valve Stenosis | Confirmed cases | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Mitral Valve Stenosis | Conservative cases | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Mitral Valve Stenosis | Confirmed cases | 0 Participants |
Secondary
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve planimetered orifice area of less than 1.5 cm\^2 as measured by echocardiography.
Time frame: 12 months
Population: ITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Mitral Valve Stenosis | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Mitral Valve Stenosis | 0 Participants |
Secondary
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve planimetered orifice area of less than 1.5 cm\^2 as measured by echocardiography.
Time frame: 30 days
Population: ITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Mitral Valve Stenosis | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Mitral Valve Stenosis | 0 Participants |
Secondary
Number of Participants With Mitral Valve Stenosis
Defined as a mitral valve planimetered orifice area of less than 1.5 cm\^2 as measured by echocardiography.
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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Mitral Valve Stenosis | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Mitral Valve Stenosis | 1 Participants |
Secondary
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: 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 | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 1+:Mild | 55 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 3+: Moderate-to-Severe | 21 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 2+: Moderate | 57 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 4+: Severe | 7 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 0: None | 9 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 4+: Severe | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 0: None | 13 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 1+:Mild | 38 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 2+: Moderate | 14 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 3+: Moderate-to-Severe | 1 Participants |
Secondary
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe. Discharge refers to each individual patient's date of hospital discharge. The discharge date varies for each patient, but in general, discharge occurs before 30-days follow-up. A 30-day echocardiogram will be used if the discharge echocardiogram is unavailable or otherwise uninterpretable.
Time frame: 30 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) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 0: None | 2 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 3+: Moderate-to-Severe | 19 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 4+: Severe | 9 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 1+:Mild | 89 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 2+: Moderate | 54 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 4+: Severe | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 2+: Moderate | 12 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 0: None | 16 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 3+: Moderate-to-Severe | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 1+:Mild | 48 Participants |
Secondary
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Time frame: 24 months
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) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 2+: Moderate | 62 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 4+: Severe | 4 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 3+: Moderate-to-Severe | 15 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 0: None | 2 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 1+: Mild | 44 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 0: None | 3 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 1+: Mild | 45 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 2+: Moderate | 7 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 3+: Moderate-to-Severe | 1 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 4+: Severe | 1 Participants |
Secondary
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: 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 | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 1+:Mild | 45 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 3+: Moderate-to-Severe | 19 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 2+: Moderate | 55 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 4+: Severe | 0 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 0: None | 3 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 4+: Severe | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 0: None | 7 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 1+:Mild | 36 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 2+: Moderate | 5 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 3+: Moderate-to-Severe | 2 Participants |
Secondary
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe
Time frame: 4 years
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) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 1+:Mild | 41 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 3+: Moderate-to-Severe | 20 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 2+: Moderate | 40 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 4+: Severe | 0 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 0: None | 4 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 4+: Severe | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 0: None | 4 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 1+:Mild | 38 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 2+: Moderate | 4 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 3+: Moderate-to-Severe | 3 Participants |
Secondary
Number of Participants With MR Severity
MR Severity of 0: None,1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: 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 | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 0: None | 4 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 1+:Mild | 49 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 2+: Moderate | 34 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 4+: Severe | 1 Participants |
| Device Group (MitraClip Device) | Number of Participants With MR Severity | 3+: Moderate-to-Severe | 18 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 2+: Moderate | 2 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 0: None | 6 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 3+: Moderate-to-Severe | 1 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 1+:Mild | 32 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With MR Severity | 4+: Severe | 0 Participants |
Secondary
Number of Participants With New Coumadin (Warfarin) Usage
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 (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With New Coumadin (Warfarin) Usage | 36 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New Coumadin (Warfarin) Usage | 33 Participants |
Secondary
Number of Participants With New Coumadin (Warfarin) Usage
Time frame: 30 days
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With New Coumadin (Warfarin) Usage | 13 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New Coumadin (Warfarin) Usage | 29 Participants |
Secondary
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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 | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class I | 70 Participants |
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class II | 27 Participants |
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class IV | 0 Participants |
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class III | 9 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class IV | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class I | 33 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class II | 8 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class III | 1 Participants |
Secondary
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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: Baseline
Population: ITT population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class II | 73 Participants |
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class IV | 12 Participants |
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class III | 82 Participants |
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class I | 17 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class IV | 4 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class III | 41 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class II | 31 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class I | 19 Participants |
Secondary
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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 | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class I | 84 Participants |
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class II | 67 Participants |
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class III | 17 Participants |
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class IV | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class IV | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class I | 40 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class III | 7 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class II | 28 Participants |
Secondary
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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 | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class II | 44 Participants |
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class I | 104 Participants |
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class III | 3 Participants |
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class IV | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class IV | 1 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class II | 12 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class III | 7 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class I | 46 Participants |
Secondary
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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: 24 months
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) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class I | 89 Participants |
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class II | 42 Participants |
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class III | 1 Participants |
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class IV | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class IV | 2 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class I | 43 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class III | 4 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class II | 11 Participants |
Secondary
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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 | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class I | 84 Participants |
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class II | 32 Participants |
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class IV | 0 Participants |
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class III | 4 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class IV | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class I | 41 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class II | 8 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class III | 1 Participants |
Secondary
Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
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 number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class I | 70 Participants |
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class III | 6 Participants |
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class IV | 0 Participants |
| Device Group (MitraClip Device) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class II | 29 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class IV | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class I | 35 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class II | 10 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease. | NYHA Functional Class III | 3 Participants |
Secondary
Number of Participants With Non-cerebral Thromboembolism.
Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.
Time frame: 12 months
Population: ITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Non-cerebral Thromboembolism. | 3 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Non-cerebral Thromboembolism. | 3 Participants |
Secondary
Number of Participants With Non-cerebral Thromboembolism.
Defined as any thrombus or thromboembolism in the vasculature (excluding central nervous system events) or on the investigational device or any commercially available implant used during surgery confirmed by standard clinical and laboratory testing and which requires treatment.
Time frame: 30 days
Population: ITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Non-cerebral Thromboembolism. | 1 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Non-cerebral Thromboembolism. | 2 Participants |
Secondary
Number of Participants With Procedural Freedom From In-hospital MAE
Time frame: Day 30
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Procedural Freedom From In-hospital MAE | 10 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Procedural Freedom From In-hospital MAE | 39 Participants |
Secondary
Number of Participants With Procedural Freedom From In-hospital MAE.
Time frame: Day 0
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Procedural Freedom From In-hospital MAE. | 168 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Procedural Freedom From In-hospital MAE. | 41 Participants |
Secondary
Number of Participants With Successful Clip Implant and Acute Procedural Success
Acute procedural success is defined as MR severity ≤ 2 at discharge or 1 grade MR reduction at discharge accompanied by 1 level NYHA reduction.
Time frame: 30 days
Population: The number of participants analyzed in Device group includes subjects who had available follow up data at that time frame. Not applicable for Mitral valve surgery patients as device was not implanted.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Successful Clip Implant and Acute Procedural Success | Device Implant Rate | 158 Participants |
| Device Group (MitraClip Device) | Number of Participants With Successful Clip Implant and Acute Procedural Success | Acute Procedural Success | 137 Participants |
Secondary
Number of Participants With Thrombosis.
Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.
Time frame: 12 months
Population: ITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Thrombosis. | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Thrombosis. | 0 Participants |
Secondary
Number of Participants With Thrombosis.
Defined as evidence of the formation of an independently moving thrombus on any part of the MitraClip or any commercially available implant used during surgery by echocardiography or fluoroscopy.
Time frame: 30 days
Population: ITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Group (MitraClip Device) | Number of Participants With Thrombosis. | 0 Participants |
| Control Group (Mitral Valve Surgery) | Number of Participants With Thrombosis. | 0 Participants |
Secondary
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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 | Value (NUMBER) |
|---|---|---|
| Device Group (MitraClip Device) | Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV | 2.0 Percentage of participants |
| Control Group (Mitral Valve Surgery) | Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV | 12.1 Percentage of participants |
Secondary
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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 | Value (NUMBER) |
|---|---|---|
| Device Group (MitraClip Device) | Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV | 3.3 Percentage of participants |
| Control Group (Mitral Valve Surgery) | Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV | 2.0 Percentage of participants |
Secondary
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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 number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device Group (MitraClip Device) | Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV | 5.7 Percentage of participants |
| Control Group (Mitral Valve Surgery) | Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV | 6.3 Percentage of participants |
Secondary
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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 | Value (NUMBER) |
|---|---|---|
| Device Group (MitraClip Device) | Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV | 8.5 Percentage of participants |
| Control Group (Mitral Valve Surgery) | Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV | 2.4 Percentage of participants |
Secondary
Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
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 | Value (NUMBER) |
|---|---|---|
| Device Group (MitraClip Device) | Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV | 0.8 Percentage of participants |
| Control Group (Mitral Valve Surgery) | Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV | 10.0 Percentage of participants |
Secondary
Post-procedure Intensive Care Unit (ICU) / Critical Care Unit (CCU) Duration
Time frame: 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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Post-procedure Intensive Care Unit (ICU) / Critical Care Unit (CCU) Duration | 38.6 hours | Standard Deviation 135.9 |
| Control Group (Mitral Valve Surgery) | Post-procedure Intensive Care Unit (ICU) / Critical Care Unit (CCU) Duration | 82.3 hours | Standard Deviation 84.9 |
Secondary
Post-procedure Length of Hospital Stay
Time frame: 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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Post-procedure Length of Hospital Stay | 2.6 days | Standard Deviation 6.3 |
| Control Group (Mitral Valve Surgery) | Post-procedure Length of Hospital Stay | 7.5 days | Standard Deviation 4 |
Secondary
Regurgitant Fraction
Regurgitant fraction is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Regurgitant Fraction | 24.5 Percentage of LV stroke volume | Standard Deviation 13.3 |
| Control Group (Mitral Valve Surgery) | Regurgitant Fraction | 20.4 Percentage of LV stroke volume | Standard Deviation 10.9 |
Secondary
Regurgitant Fraction
Regurgitant fraction is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Regurgitant Fraction | 22.8 Percentage of LV stroke volume | Standard Deviation 13.8 |
| Control Group (Mitral Valve Surgery) | Regurgitant Fraction | 19.2 Percentage of LV stroke volume | Standard Deviation 12.1 |
Secondary
Regurgitant Fraction (RF)
RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
Time frame: 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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Regurgitant Fraction (RF) | 25.4 percentage of LV stroke volume | Standard Deviation 15.3 |
| Control Group (Mitral Valve Surgery) | Regurgitant Fraction (RF) | 17.3 percentage of LV stroke volume | Standard Deviation 13.1 |
Secondary
Regurgitant Volume
Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.
Time frame: 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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Regurgitant Volume | 22.7 mL | Standard Deviation 17.6 |
| Control Group (Mitral Valve Surgery) | Regurgitant Volume | 13.1 mL | Standard Deviation 10.7 |
Secondary
Regurgitant Volume
Regurgitant volume as determined by the core echo 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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Regurgitant Volume | 19.9 mL | Standard Deviation 14.4 |
| Control Group (Mitral Valve Surgery) | Regurgitant Volume | 14.6 mL | Standard Deviation 10.5 |
Secondary
Regurgitant Volume
Regurgitant volume as determined by the core echo 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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Regurgitant Volume | 19.4 mL | Standard Deviation 13.2 |
| Control Group (Mitral Valve Surgery) | Regurgitant Volume | 15.7 mL | Standard Deviation 10.5 |
Secondary
Short Form (SF)-36 Quality of Life Questionnaire.
The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) & mental health status (Mental Component Score) 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: The SF-36 questionnaire consists of 36 questions in relation to eight health concepts:~Physical functioning, role limitations due to physical health, bodily pain,general health perceptions,vitality (energy/fatigue),social functioning,role limitations due to emotional health and general mental health (psychological distress/wellbeing).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device Group (MitraClip Device) | Short Form (SF)-36 Quality of Life Questionnaire. | Physical Component Summary | 43.8 scores on a scale | Standard Deviation 9.8 |
| Device Group (MitraClip Device) | Short Form (SF)-36 Quality of Life Questionnaire. | Mental Component Summary | 50.8 scores on a scale | Standard Deviation 10.8 |
| Control Group (Mitral Valve Surgery) | Short Form (SF)-36 Quality of Life Questionnaire. | Physical Component Summary | 36.9 scores on a scale | Standard Deviation 9.9 |
| Control Group (Mitral Valve Surgery) | Short Form (SF)-36 Quality of Life Questionnaire. | Mental Component Summary | 46.7 scores on a scale | Standard Deviation 12.4 |
Secondary
Short Form (SF)-36 Quality of Life Questionnaire.
The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score) & mental health status (Mental Component Score) 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: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device Group (MitraClip Device) | Short Form (SF)-36 Quality of Life Questionnaire. | Physical Component Summary | 46.8 scores on a scale | Standard Deviation 9.5 |
| Device Group (MitraClip Device) | Short Form (SF)-36 Quality of Life Questionnaire. | Mental Component Summary | 52.9 scores on a scale | Standard Deviation 8 |
| Control Group (Mitral Valve Surgery) | Short Form (SF)-36 Quality of Life Questionnaire. | Mental Component Summary | 50.4 scores on a scale | Standard Deviation 10.9 |
| Control Group (Mitral Valve Surgery) | Short Form (SF)-36 Quality of Life Questionnaire. | Physical Component Summary | 46.5 scores on a scale | Standard Deviation 10.6 |
Secondary
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Time frame: 4 year
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group (MitraClip Device) | Transvalvular Mitral Mean Pressure Gradient (Mean MVG) | 3.0 mmHg | Standard Deviation 1.4 |
| Control Group (Mitral Valve Surgery) | Transvalvular Mitral Mean Pressure Gradient (Mean MVG) | 3.1 mmHg | Standard Deviation 1.5 |
Secondary
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Time frame: 5 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group (MitraClip Device) | Transvalvular Mitral Mean Pressure Gradient (Mean MVG) | 3.0 mmHg | Standard Deviation 1.4 |
| Control Group (Mitral Valve Surgery) | Transvalvular Mitral Mean Pressure Gradient (Mean MVG) | 3.0 mmHg | Standard Deviation 1.4 |
Secondary
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Defined as the mean pressure gradient across the mitral valve as measured by Echocardiography Core Laboratory (ECL).
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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Transvalvular Mitral Mean Pressure Gradient (Mean MVG) | 3.2 mmHg | Standard Deviation 1.7 |
| Control Group (Mitral Valve Surgery) | Transvalvular Mitral Mean Pressure Gradient (Mean MVG) | 3.1 mmHg | Standard Deviation 1.2 |
Secondary
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Transvalvular Mitral Mean Pressure Gradient (Mean MVG) | 2.8 mmHg | Standard Deviation 1.4 |
| Control Group (Mitral Valve Surgery) | Transvalvular Mitral Mean Pressure Gradient (Mean MVG) | 2.9 mmHg | Standard Deviation 1.8 |
Secondary
Transvalvular Mitral Mean Pressure Gradient (Mean MVG)
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Time frame: 3 year
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Device Group (MitraClip Device) | Transvalvular Mitral Mean Pressure Gradient (Mean MVG) | 3.0 mmHg | Standard Deviation 1.5 |
| Control Group (Mitral Valve Surgery) | Transvalvular Mitral Mean Pressure Gradient (Mean MVG) | 2.8 mmHg | Standard Deviation 1.4 |
Secondary
Transvalvular Mitral Valve Gradient
Defined as the mean pressure gradient across the mitral valve as measured by echocardiography.
Time frame: At Discharge (≤ 14 days following 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 |
|---|---|---|---|
| Device Group (MitraClip Device) | Transvalvular Mitral Valve Gradient | 3.3 mmHg | Standard Deviation 1.9 |
| Control Group (Mitral Valve Surgery) | Transvalvular Mitral Valve Gradient | 3.1 mmHg | Standard Deviation 1.6 |