ClinicalTrials.gov
ClinicalTrials.gov Menu

Pivotal Study of a Percutaneous Mitral Valve Repair System (EVERESTIIRCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00209274
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : September 5, 2017
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Incompetence
Mitral Regurgitation
Mitral Insufficiency
Interventions Device: Percutaneous mitral valve repair using MitraClip implant
Procedure: Mitral valve repair or replacement surgery
Enrollment 279
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.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description Percutaneous mitral valve repair using MitraClip implant. Mitral valve repair or replacement surgery.
Period Title: Overall Study
Started 184 95
Completed 113 48
Not Completed 71 47
Reason Not Completed
Missed visit             3             2
Death             32             15
Withdrawal by Subject             30             15
Randomized not treated (RNT)             6             15
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery) Total
Hide Arm/Group Description Percutaneous mitral valve repair using MitraClip implant. Mitral valve repair or replacement surgery. Total of all reporting groups
Overall Number of Baseline Participants 184 95 279
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 184 participants 95 participants 279 participants
67.3  (12.8) 65.7  (12.9) 66.7  (12.8)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 184 participants 95 participants 279 participants
18-75 years
129
  70.1%
69
  72.6%
198
  71.0%
>75 years
55
  29.9%
26
  27.4%
81
  29.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 184 participants 95 participants 279 participants
Female
69
  37.5%
32
  33.7%
101
  36.2%
Male
115
  62.5%
63
  66.3%
178
  63.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 184 participants 95 participants 279 participants
United States
177
  96.2%
93
  97.9%
270
  96.8%
Canada
7
   3.8%
2
   2.1%
9
   3.2%
NYHA Functional Class   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 184 participants 95 participants 279 participants
NYHA Functional Class I
17
   9.2%
19
  20.0%
36
  12.9%
NYHA Functional Class II
73
  39.7%
31
  32.6%
104
  37.3%
NYHA Functional Class III
82
  44.6%
41
  43.2%
123
  44.1%
NYHA Functional Class IV
12
   6.5%
4
   4.2%
16
   5.7%
[1]
Measure Description: 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. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or anginal syndrome may be present even at rest & discomfort is increased with physical activity.
Mitral regurgitation (MR)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 184 participants 95 participants 279 participants
0: None
0
   0.0%
0
   0.0%
0
   0.0%
1+: Mild
0
   0.0%
0
   0.0%
0
   0.0%
2+: Moderate
8
   4.3%
7
   7.4%
15
   5.4%
3+: Moderate-to-Severe
130
  70.7%
67
  70.5%
197
  70.6%
4+: Severe
46
  25.0%
21
  22.1%
67
  24.0%
Left Ventricular (LV) Measurement  
Mean (Standard Deviation)
Unit of measure:  mL
Number Analyzed 184 participants 95 participants 279 participants
LV End Diastolic Volume (LVEDV) 156.5  (39.0) 159.6  (46.3) 158.05  (42.65)
LV End Systolic Volume (LVESV) 63.5  (25.5) 63.8  (28.9) 63.65  (27.20)
Left Ventricular (LV) Measurement  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 184 participants 95 participants 279 participants
LV internal dimension diastole (LVIDd) 5.5  (0.7) 5.5  (0.7) 5.5  (0.7)
LV internal dimension systole (LVIDs) 3.7  (0.9) 3.5  (0.8) 3.6  (0.85)
36-Item Short Form Health Survey (SF-36) Quality of Life (QOL)   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 184 participants 95 participants 279 participants
Physical Component Score 41.1  (10.0) 41.9  (11.1) 41.4  (10.3)
Mental Component Score 47.1  (11.9) 46.6  (12.5) 46.9  (12.0)
[1]
Measure Description: The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Higher scores represent better self-perceived health. The PCS & MCS norms for 65-75 year olds are 44 and 52, while the norms for CHF population are 31 and 46, respectively.
1.Primary Outcome
Title Number of Participants With Major Adverse Events (MAE)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol cohort. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 136 79
Measure Type: Count of Participants
Unit of Measure: Participants
13
   9.6%
45
  57.0%
2.Primary Outcome
Title Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol cohort. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 134 74
Measure Type: Count of Participants
Unit of Measure: Participants
97
  72.4%
65
  87.8%
3.Secondary Outcome
Title Freedom From All-Cause Mortality
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 158 70
Measure Type: Number
Unit of Measure: Percentage of participants
93.7 92.3
4.Secondary Outcome
Title Freedom From All-Cause Mortality
Hide Description [Not Specified]
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 143 65
Measure Type: Number
Unit of Measure: Percentage of participants
90.0 89.6
5.Secondary Outcome
Title Freedom From All-Cause Mortality
Hide Description [Not Specified]
Time Frame 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 133 57
Measure Type: Number
Unit of Measure: Percentage of participants
87.5 85.3
6.Secondary Outcome
Title Freedom From All-Cause Mortality
Hide Description [Not Specified]
Time Frame 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 119 52
Measure Type: Number
Unit of Measure: Percentage of participants
83.4 82.3
7.Secondary Outcome
Title Freedom From All-Cause Mortality
Hide Description [Not Specified]
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 58 24
Measure Type: Number
Unit of Measure: Percentage of participants
81.2 79
8.Secondary Outcome
Title Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation.
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 175 89
Measure Type: Count of Participants
Unit of Measure: Participants
118
  67.4%
65
  73.0%
9.Secondary Outcome
Title Number of Participants With Freedom From Surgery for Valve Dysfunction, Death, and Moderate to Severe (3+) or Severe (4+) Mitral Regurgitation (MR).
Hide Description [Not Specified]
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population.The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 126 68
Measure Type: Count of Participants
Unit of Measure: Participants
87
  69.0%
55
  80.9%
10.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 161 83
Measure Type: Number
Unit of Measure: participants
100 56
11.Secondary Outcome
Title Left Ventricular Ejection Fraction (LVEF)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 170 77
Mean (Standard Deviation)
Unit of Measure: Percentage of volume ejected
56.9  (10.0) 53.9  (10.9)
12.Secondary Outcome
Title Left Ventricular Ejection Fraction (LVEF)
Hide Description LVEF as determined by the core echo laboratory.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 144 65
Mean (Standard Deviation)
Unit of Measure: Percentage of volume ejected
58.0  (8.7) 55.3  (10.2)
13.Secondary Outcome
Title Left Ventricular Ejection Fraction (LVEF)
Hide Description LVEF as determined by the core echo laboratory.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 125 56
Mean (Standard Deviation)
Unit of Measure: Percentage of volume ejected
56.9  (8.3) 55.8  (8.1)
14.Secondary Outcome
Title Left Ventricular Ejection Fraction (LVEF)
Hide Description LVEF as determined by the core echo laboratory.
Time Frame 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 119 47
Mean (Standard Deviation)
Unit of Measure: Percentage of volume ejected
57.0  (9.1) 58.4  (9.2)
15.Secondary Outcome
Title Left Ventricular Ejection Fraction (LVEF)
Hide Description LVEF as determined by the core echo laboratory.
Time Frame 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 102 45
Mean (Standard Deviation)
Unit of Measure: Percentage of volume ejected
57.6  (9.9) 58.9  (10.2)
16.Secondary Outcome
Title Left Ventricular Ejection Fraction (LVEF)
Hide Description LVEF as determined by the core echo laboratory.
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 105 40
Mean (Standard Deviation)
Unit of Measure: Percentage of volume ejected
56.5  (10.1) 57  (9.3)
17.Secondary Outcome
Title Left Ventricular Status- Left Ventricular End-diastolic Volume (LVEDV), Left Ventricular End-systolic Volume (LVESV)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 170 77
Mean (Standard Deviation)
Unit of Measure: ml
LVEDV 144.7  (40.0) 130.8  (40.5)
LVESV 63.7  (27.2) 62.0  (29.2)
18.Secondary Outcome
Title Left Ventricular Status- LVEDV, LVESV
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 144 65
Mean (Standard Deviation)
Unit of Measure: ml
LVEDV 133.7  (35.5) 120.9  (44.3)
LVESV 57.5  (24.0) 56.2  (31.4)
19.Secondary Outcome
Title Left Ventricular Status- LVEDV, LVESV
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 125 56
Mean (Standard Deviation)
Unit of Measure: mL
LVEDV 123.4  (35.0) 110.5  (40.9)
LVESV 54.7  (24.7) 50.4  (26.3)
20.Secondary Outcome
Title Left Ventricular Status- LVEDV, LVESV
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 119 47
Mean (Standard Deviation)
Unit of Measure: ml
LVEDV 130.6  (32.6) 112.7  (40.2)
LVESV 57.7  (24.7) 48.0  (24.7)
21.Secondary Outcome
Title Left Ventricular Status- LVEDV, LVESV
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 102 45
Mean (Standard Deviation)
Unit of Measure: ml
LVEDV 126.6  (33.1) 112.7  (40.4)
LVESV 55.0  (24.4) 48.1  (26.9)
22.Secondary Outcome
Title Left Ventricular Status- LVEDV, LVESV
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 105 40
Mean (Standard Deviation)
Unit of Measure: ml
LVEDV 126.3  (32.5) 112.9  (37.8)
LVESV 56.1  (23) 50.1  (26.3)
23.Secondary Outcome
Title Left Ventricular Internal Dimension Systole (LVIDs)
Hide Description Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 169 77
Mean (Standard Deviation)
Unit of Measure: cm
3.6  (0.9) 3.5  (0.8)
24.Secondary Outcome
Title Left Ventricular Internal Dimension Systole (LVIDs)
Hide Description Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 146 66
Mean (Standard Deviation)
Unit of Measure: cm
3.5  (0.8) 3.3  (0.8)
25.Secondary Outcome
Title Left Ventricular Internal Dimension Systole (LVIDs)
Hide Description Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 125 58
Mean (Standard Deviation)
Unit of Measure: cm
3.4  (0.8) 3.2  (0.9)
26.Secondary Outcome
Title Left Ventricular Internal Dimension Systole (LVIDs)
Hide Description Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time Frame 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 120 50
Mean (Standard Deviation)
Unit of Measure: cm
3.6  (0.9) 3.2  (0.8)
27.Secondary Outcome
Title Left Ventricular Internal Dimension Systole (LVIDs)
Hide Description Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time Frame 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 102 46
Mean (Standard Deviation)
Unit of Measure: cm
3.6  (0.9) 3.3  (0.8)
28.Secondary Outcome
Title Left Ventricular Internal Dimension Systole (LVIDs)
Hide Description Left Ventricular internal dimension systole (LVIDs) as determined by the core echo laboratory.
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 104 42
Mean (Standard Deviation)
Unit of Measure: cm
3.6  (0.9) 3.3  (0.9)
29.Secondary Outcome
Title Left Ventricular Internal Dimension Diastole (LVIDd)
Hide Description Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory.
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 171 77
Mean (Standard Deviation)
Unit of Measure: cm
5.3  (0.7) 5.0  (0.7)
30.Secondary Outcome
Title Left Ventricular Internal Dimension Diastole (LVIDd)
Hide Description Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 12 months.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 148 66
Mean (Standard Deviation)
Unit of Measure: cm
5.1  (0.7) 4.8  (0.7)
31.Secondary Outcome
Title Left Ventricular Internal Dimension Diastole (LVIDd)
Hide Description Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 24 months.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 127 58
Mean (Standard Deviation)
Unit of Measure: cm
5.0  (0.7) 4.7  (0.8)
32.Secondary Outcome
Title Left Ventricular Internal Dimension Diastole (LVIDd)
Hide Description Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 3 years.
Time Frame 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 122 50
Mean (Standard Deviation)
Unit of Measure: cm
5.2  (0.7) 4.8  (0.7)
33.Secondary Outcome
Title Left Ventricular Internal Dimension Diastole (LVIDd)
Hide Description Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 4 years.
Time Frame 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 102 46
Mean (Standard Deviation)
Unit of Measure: cm
5.3  (0.6) 4.8  (0.7)
34.Secondary Outcome
Title Left Ventricular Internal Dimension Diastole (LVIDd)
Hide Description Left Ventricular internal dimension diastole (LVIDd) as determined by the core echo laboratory at 5 years.
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 106 42
Mean (Standard Deviation)
Unit of Measure: cm
5.2  (0.6) 4.9  (0.7)
35.Secondary Outcome
Title Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 184 95
Measure Type: Count of Participants
Unit of Measure: Participants
NYHA Functional Class I
17
   9.2%
19
  20.0%
NYHA Functional Class II
73
  39.7%
31
  32.6%
NYHA Functional Class III
82
  44.6%
41
  43.2%
NYHA Functional Class IV
12
   6.5%
4
   4.2%
36.Secondary Outcome
Title Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 168 75
Measure Type: Count of Participants
Unit of Measure: Participants
NYHA Functional Class I
84
  50.0%
40
  53.3%
NYHA Functional Class II
67
  39.9%
28
  37.3%
NYHA Functional Class III
17
  10.1%
7
   9.3%
NYHA Functional Class IV
0
   0.0%
0
   0.0%
37.Secondary Outcome
Title Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 151 66
Measure Type: Count of Participants
Unit of Measure: Participants
NYHA Functional Class I
104
  68.9%
46
  69.7%
NYHA Functional Class II
44
  29.1%
12
  18.2%
NYHA Functional Class III
3
   2.0%
7
  10.6%
NYHA Functional Class IV
0
   0.0%
1
   1.5%
38.Secondary Outcome
Title Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 132 60
Measure Type: Count of Participants
Unit of Measure: Participants
NYHA Functional Class I
89
  67.4%
43
  71.7%
NYHA Functional Class II
42
  31.8%
11
  18.3%
NYHA Functional Class III
1
   0.8%
4
   6.7%
NYHA Functional Class IV
0
   0.0%
2
   3.3%
39.Secondary Outcome
Title Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 120 50
Measure Type: Count of Participants
Unit of Measure: Participants
NYHA Functional Class I
84
  70.0%
41
  82.0%
NYHA Functional Class II
32
  26.7%
8
  16.0%
NYHA Functional Class III
4
   3.3%
1
   2.0%
NYHA Functional Class IV
0
   0.0%
0
   0.0%
40.Secondary Outcome
Title Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 105 48
Measure Type: Count of Participants
Unit of Measure: Participants
NYHA Functional Class I
70
  66.7%
35
  72.9%
NYHA Functional Class II
29
  27.6%
10
  20.8%
NYHA Functional Class III
6
   5.7%
3
   6.3%
NYHA Functional Class IV
0
   0.0%
0
   0.0%
41.Secondary Outcome
Title Number of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease.
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 106 42
Measure Type: Count of Participants
Unit of Measure: Participants
NYHA Functional Class I
70
  66.0%
33
  78.6%
NYHA Functional Class II
27
  25.5%
8
  19.0%
NYHA Functional Class III
9
   8.5%
1
   2.4%
NYHA Functional Class IV
0
   0.0%
0
   0.0%
42.Secondary Outcome
Title New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 168 75
Measure Type: Number
Unit of Measure: Percentage of participants
10.1 9.3
43.Secondary Outcome
Title Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 151 66
Measure Type: Number
Unit of Measure: Percentage of participants
2.0 12.1
44.Secondary Outcome
Title Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 132 60
Measure Type: Number
Unit of Measure: Percentage of participants
0.8 10.0
45.Secondary Outcome
Title Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 120 50
Measure Type: Number
Unit of Measure: Percentage of participants
3.3 2.0
46.Secondary Outcome
Title Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 105 48
Measure Type: Number
Unit of Measure: Percentage of participants
5.7 6.3
47.Secondary Outcome
Title Percentage of Participants With New York Heart Association (NYHA) Functional Class Cardiac Disease: NYHA Functional Class III or IV
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 106 42
Measure Type: Number
Unit of Measure: Percentage of participants
8.5 2.4
48.Secondary Outcome
Title Short Form (SF)-36 Quality of Life Questionnaire.
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 159 68
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Physical Component Summary 43.8  (9.8) 36.9  (9.9)
Mental Component Summary 50.8  (10.8) 46.7  (12.4)
49.Secondary Outcome
Title Short Form (SF)-36 Quality of Life Questionnaire.
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 139 64
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Physical Component Summary 46.8  (9.5) 46.5  (10.6)
Mental Component Summary 52.9  (8.0) 50.4  (10.9)
50.Secondary Outcome
Title Cardiac Output
Hide Description Cardiac output as measured by core lab echocardiography.
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 162 71
Mean (Standard Deviation)
Unit of Measure: L/min
4.2  (1.2) 4.8  (1.3)
51.Secondary Outcome
Title Cardiac Output
Hide Description Cardiac output as measured by core lab echocardiography.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 147 67
Mean (Standard Deviation)
Unit of Measure: L/min
4.4  (1.3) 4.6  (1.4)
52.Secondary Outcome
Title Cardiac Output
Hide Description Cardiac output as measured by core lab echocardiography.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 121 57
Mean (Standard Deviation)
Unit of Measure: L/min
4.0  (1.1) 4.1  (1.1)
53.Secondary Outcome
Title Cardiac Index
Hide Description Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 158 71
Mean (Standard Deviation)
Unit of Measure: L/min/m^2
2.2  (0.6) 2.5  (0.6)
54.Secondary Outcome
Title Cardiac Index (CI)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 145 65
Mean (Standard Deviation)
Unit of Measure: L/min/m^2
2.3  (0.6) 2.4  (0.6)
55.Secondary Outcome
Title Cardiac Index
Hide Description Defined as cardiac output divided by body surface area, as measured by core lab echocardiography.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 121 56
Mean (Standard Deviation)
Unit of Measure: L/min/m^2
2.1  (0.5) 2.1  (0.5)
56.Secondary Outcome
Title Regurgitant Volume
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 131 45
Mean (Standard Deviation)
Unit of Measure: mL
22.7  (17.6) 13.1  (10.7)
57.Secondary Outcome
Title Regurgitant Volume
Hide Description Regurgitant volume as determined by the core echo laboratory.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 115 34
Mean (Standard Deviation)
Unit of Measure: mL
19.9  (14.4) 14.6  (10.5)
58.Secondary Outcome
Title Regurgitant Volume
Hide Description Regurgitant volume as determined by the core echo laboratory.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 85 25
Mean (Standard Deviation)
Unit of Measure: mL
19.4  (13.2) 15.7  (10.5)
59.Secondary Outcome
Title Regurgitant Fraction (RF)
Hide Description RF is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
Time Frame 30 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 131 45
Mean (Standard Deviation)
Unit of Measure: percentage of LV stroke volume
25.4  (15.3) 17.3  (13.1)
60.Secondary Outcome
Title Regurgitant Fraction
Hide Description Regurgitant fraction is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 115 34
Mean (Standard Deviation)
Unit of Measure: Percentage of LV stroke volume
22.8  (13.8) 19.2  (12.1)
61.Secondary Outcome
Title Regurgitant Fraction
Hide Description Regurgitant fraction is defined as the percentage of the left ventricular (LV) stroke volume that regurgitates into the left atrium.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 85 25
Mean (Standard Deviation)
Unit of Measure: Percentage of LV stroke volume
24.5  (13.3) 20.4  (10.9)
62.Secondary Outcome
Title Number of Participants With Clip Implant Rate
Hide Description Defined as the rate of successful implantation of MitraClip(s).
Time Frame Day 0
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 178 0
Measure Type: Count of Participants
Unit of Measure: Participants
158
  88.8%
63.Secondary Outcome
Title Number of Participants With Acute Procedural Success
Hide Description Defined as successful MitraClip implantation with resulting MR of 2+ or less.
Time Frame 30 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 184 0
Measure Type: Count of Participants
Unit of Measure: Participants
137
  74.5%
64.Secondary Outcome
Title Number of Participants With Acute Surgical Success
Hide Description Defined as successful mitral valve repair or replacement surgery.
Time Frame 30 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 0 80
Measure Type: Count of Participants
Unit of Measure: Participants
80
 100.0%
65.Secondary Outcome
Title Number of Participants With Successful Clip Implant and Acute Procedural Success
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 178 0
Measure Type: Count of Participants
Unit of Measure: Participants
Device Implant Rate
158
  88.8%
Acute Procedural Success
137
  77.0%
66.Secondary Outcome
Title Number of Participants With Mitral Valve Repair Success.
Hide Description Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 177 91
Measure Type: Count of Participants
Unit of Measure: Participants
114
  64.4%
57
  62.6%
67.Secondary Outcome
Title Number of Participants With Mitral Valve Repair Success.
Hide Description Defined as freedom from mitral valve replacement surgery for Valve Dysfunction, death, re-operation, and MR > 2+ at 12 months.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 167 84
Measure Type: Count of Participants
Unit of Measure: Participants
103
  61.7%
46
  54.8%
68.Secondary Outcome
Title Number of Participants With Procedural Freedom From In-hospital MAE.
Hide Description [Not Specified]
Time Frame Day 0
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 178 80
Measure Type: Count of Participants
Unit of Measure: Participants
168
  94.4%
41
  51.2%
69.Secondary Outcome
Title Number of Participants With Procedural Freedom From In-hospital MAE
Hide Description [Not Specified]
Time Frame Day 30
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 178 80
Measure Type: Count of Participants
Unit of Measure: Participants
10
   5.6%
39
  48.8%
70.Secondary Outcome
Title Number of Participants With MAE: Surgery After Device and First Time Surgery Control
Hide Description [Not Specified]
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 37 80
Measure Type: Count of Participants
Unit of Measure: Participants
14
  37.8%
40
  50.0%
71.Secondary Outcome
Title Number of Participants With Major Vascular Complications
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 184 95
Measure Type: Count of Participants
Unit of Measure: Participants
9
   4.9%
0
   0.0%
72.Secondary Outcome
Title Number of Participants With Major Vascular Complications
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 184 95
Measure Type: Count of Participants
Unit of Measure: Participants
11
   6.0%
0
   0.0%
73.Secondary Outcome
Title Number of Participants With Major Bleeding Complications.
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 184 95
Measure Type: Count of Participants
Unit of Measure: Participants
9
   4.9%
38
  40.0%
74.Secondary Outcome
Title Number of Participants With Major Bleeding Complications.
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 184 95
Measure Type: Count of Participants
Unit of Measure: Participants
17
   9.2%
39
  41.1%
75.Secondary Outcome
Title Number of Participants With Major Adverse Events (MAE)
Hide Description [Not Specified]
Time Frame 12 months.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 184 95
Measure Type: Count of Participants
Unit of Measure: Participants
39
  21.2%
44
  46.3%
76.Secondary Outcome
Title Number of Participants With MAE in Patients Over 75 Years of Age.
Hide Description [Not Specified]
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 55 26
Measure Type: Count of Participants
Unit of Measure: Participants
9
  16.4%
12
  46.2%
77.Secondary Outcome
Title Number of Participants With MAE in Patients Over 75 Years of Age.
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 55 26
Measure Type: Count of Participants
Unit of Measure: Participants
14
  25.5%
14
  53.8%
78.Secondary Outcome
Title Number of Participants With Dysrhythmia
Hide Description [Not Specified]
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 184 95
Measure Type: Count of Participants
Unit of Measure: Participants
9
   4.9%
22
  23.2%
79.Secondary Outcome
Title Number of Participants With Dysrhythmia
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 184 95
Measure Type: Count of Participants
Unit of Measure: Participants
22
  12.0%
22
  23.2%
80.Secondary Outcome
Title Number of Participants With Endocarditis.
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 184 95
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.5%
1
   1.1%
81.Secondary Outcome
Title Number of Participants With Endocarditis.
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 184 95
Measure Type: Count of Participants
Unit of Measure: Participants
2
   1.1%
1
   1.1%
82.Secondary Outcome
Title Number of Participants With Thrombosis.
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 184 95
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
83.Secondary Outcome
Title Number of Participants With Thrombosis.
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 184 95
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
84.Secondary Outcome
Title Number of Participants With Hemolysis
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 184 95
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
85.Secondary Outcome
Title Number of Participants With Hemolysis
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 184 95
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
86.Secondary Outcome
Title Number of Participants With Clinically Significant Atrial Septal Defect (ASD).
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 184 95
Measure Type: Count of Participants
Unit of Measure: Participants
2
   1.1%
0
   0.0%
87.Secondary Outcome
Title Number of Participants With Clinically Significant Atrial Septal Defect (ASD)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 184 95
Measure Type: Count of Participants
Unit of Measure: Participants
4
   2.2%
0
   0.0%
88.Secondary Outcome
Title Number of Participants With Mitral Valve Stenosis
Hide Description Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 184 95
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
89.Secondary Outcome
Title Number of Participants With Mitral Valve Stenosis
Hide Description Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 184 95
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
90.Secondary Outcome
Title Number of Participants With Mitral Valve Stenosis
Hide Description Defined as a mitral valve planimetered orifice area of less than 1.5 cm^2 as measured by echocardiography.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 178 80
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   1.3%
91.Secondary Outcome
Title Number of Participants With Mitral Valve Stenosis
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 178 80
Measure Type: Count of Participants
Unit of Measure: Participants
Conservative cases
3
   1.7%
0
   0.0%
Confirmed cases
0
   0.0%
0
   0.0%
92.Secondary Outcome
Title Number of Participants With Mitral Valve Stenosis
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Percutaneous mitral valve repair using MitraClip implant.
Mitral valve repair or replacement surgery.
Overall Number of Participants Analyzed 178 80
Measure Type: Count of Participants
Unit of Measure: Participants
Conservative cases
3
   1.7%
0
   0.0%
Confirmed cases
0
   0.0%
0
   0.0%
93.Secondary Outcome
Title Number of Participants With Mitral Valve Stenosis
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title Device Group (MitraClip Device) Control Group (Mitral Valve Surgery)
Hide Arm/Group Description:
Per