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Trial record 1 of 1 for:    NCT01626079
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Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) (COAPT)

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: NCT01626079
Recruitment Status : Active, not recruiting
First Posted : June 22, 2012
Results First Posted : May 6, 2020
Last Update Posted : May 6, 2020
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 Regurgitation
Mitral Valve Regurgitation
Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects
Heart Failure
Intervention Device: MitraClip System
Enrollment 614
Recruitment Details

In COAPT, 614 subjects were randomized. Enrollment concluded on June 23, 2017.

Of the 614 randomized subjects, 302 were in Device group and 312 in the Control group. Subject follow-up is on-going.

Pre-assignment Details This section includes the results for the primary safety, primary effectiveness, and the 10 secondary endpoints that are the most essential outcomes of the trial.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Period Title: Overall Study
Started 302 312
Completed 135 96
Not Completed 167 216
Reason Not Completed
Death             78             115
Withdrawal by Subject             12             29
Lost to Follow-up             3             3
Visits Expected or Not Due             74             69
Arm/Group Title MitraClip System Control Group Total
Hide Arm/Group Description

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice. Total of all reporting groups
Overall Number of Baseline Participants 302 312 614
Hide Baseline Analysis Population Description
Of the 614 subjects, 302 from MitraClip system group and 312 from Control group completed the baseline visit.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 302 participants 312 participants 614 participants
71.7  (11.8) 72.8  (10.5) 72.2  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants 312 participants 614 participants
Female
101
  33.4%
120
  38.5%
221
  36.0%
Male
201
  66.6%
192
  61.5%
393
  64.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 302 participants 312 participants 614 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
6
   2.0%
12
   3.8%
18
   2.9%
Black or African American
44
  14.6%
44
  14.1%
88
  14.3%
Hispanic or Latino
20
   6.6%
20
   6.4%
40
   6.5%
Native Hawaiian or Other Pacific Islander
1
   0.3%
0
   0.0%
1
   0.2%
White or Caucasian
225
  74.5%
232
  74.4%
457
  74.4%
Other
6
   2.0%
4
   1.3%
10
   1.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 302 participants 312 participants 614 participants
12 14 26
United States Number Analyzed 302 participants 312 participants 614 participants
290 298 588
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 301 participants 306 participants 607 participants
170.84  (10.35) 169.86  (10.75) 170.34  (10.56)
[1]
Measure Analysis Population Description: Data is missing for 1 subject in Device group and 6 subjects in control group
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 301 participants 307 participants 608 participants
78.79  (17.23) 78.40  (20.06) 78.59  (18.70)
[1]
Measure Analysis Population Description: Data is missing for 1 subject in Device group and 5 subjects in Control group.
Body Mass Index (kg/m^2)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 301 participants 305 participants 606 participants
27.04  (5.81) 27.05  (5.96) 27.05  (5.88)
[1]
Measure Analysis Population Description: Data is missing for 2 subjects for Device and 7 subjects for Control group.
Serum Creatinine (mg/dL)   [1] 
Mean (Standard Deviation)
Unit of measure:  (mg/dL)
Number Analyzed 300 participants 306 participants 606 participants
1.77  (1.22) 1.80  (1.42) 1.79  (1.32)
[1]
Measure Analysis Population Description: Data is missing for 2 subjects in Device group and 6 subjects in Control group.
Creatinine Clearance (mL/min)   [1] 
Mean (Standard Deviation)
Unit of measure:  mL/min
Number Analyzed 299 participants 302 participants 601 participants
50.87  (28.48) 47.76  (24.97) 49.31  (26.79)
[1]
Measure Analysis Population Description: Data is missing for 3 subjects in Device group and 10 subjects in Control group.
Creatinine Clearance <= 60mL/min   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 299 participants 302 participants 601 participants
214
  71.6%
227
  75.2%
441
  73.4%
[1]
Measure Analysis Population Description: Data is missing for 3 subjects in Device group and 10 subjects in Control group
Brain Natriuretic Peptide (Pg/mL)   [1] 
Mean (Standard Deviation)
Unit of measure:  Pg/mL
Number Analyzed 208 participants 209 participants 417 participants
1014.77  (1085.98) 1017.13  (1212.77) 1015.95  (1149.89)
[1]
Measure Analysis Population Description: Not all subjects had Brain Natriuretic Peptide (BNP) value collected. some subjects were on NT-proBNP.
NT-proBNP (pg/mL)   [1] 
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 74 participants 85 participants 159 participants
5174.33  (6566.61) 5943.86  (8437.61) 5585.71  (7610.56)
[1]
Measure Analysis Population Description: Majority of subjects had BNP available. Subjects who did not have BNP had NT-proBNP available.
Elevated BNP or NT-BNP prior to Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 286 participants 303 participants 589 participants
267
  93.4%
282
  93.1%
549
  93.2%
[1]
Measure Analysis Population Description: All available data reported
Extremely High Risk for MV Surgery   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 299 participants 312 participants 611 participants
205
  68.6%
218
  69.9%
423
  69.2%
[1]
Measure Description:

High surgical risk if investigational site assessed a predicted surgical mortality for mitral valve surgery of ≥ 12% based on either:

I) STS (Society of Thoracic Surgeons) mortality risk ≥ 12%, or

II) The presence of at least one of the following:

  1. Porcelain aorta or mobile ascending aortic atheroma
  2. Post-radiation mediastinum
  3. Previous mediastinitis
  4. Functional MR with EF < 40%
  5. Over 75 years old with EF < 40%
  6. Prior re-operation with patent grafts
  7. Two or more prior chest surgeries
  8. Hepatic cirrhosis
  9. Three or more of the following STS high risk factors
[2]
Measure Analysis Population Description: Not all subjects met the criteria for High Risk for MV Surgery
Diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants 312 participants 614 participants
106
  35.1%
123
  39.4%
229
  37.3%
Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants 312 participants 614 participants
243
  80.5%
251
  80.4%
494
  80.5%
Hypercholesterolemia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants 312 participants 614 participants
166
  55.0%
163
  52.2%
329
  53.6%
Previous Myocardial Infarction  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants 312 participants 614 participants
156
  51.7%
160
  51.3%
316
  51.5%
Previous Percutaneous Coronary Intervention  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants 312 participants 614 participants
130
  43.0%
153
  49.0%
283
  46.1%
Previous Coronary Artery Bypass Grafting  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants 312 participants 614 participants
121
  40.1%
126
  40.4%
247
  40.2%
Previous Stroke or Transient Ischemic Attack  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants 312 participants 614 participants
56
  18.5%
49
  15.7%
105
  17.1%
Peripheral Vascular Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants 312 participants 614 participants
52
  17.2%
57
  18.3%
109
  17.8%
Chronic Obstructive Pulmonary Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants 312 participants 614 participants
71
  23.5%
72
  23.1%
143
  23.3%
History of Atrial Fibrillation or Flutter  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants 312 participants 614 participants
173
  57.3%
166
  53.2%
339
  55.2%
Anemia   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 301 participants 306 participants 607 participants
180
  59.8%
192
  62.7%
372
  61.3%
[1]
Measure Analysis Population Description: All available data is reported
STS Risk Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of expected mortality
Number Analyzed 302 participants 312 participants 614 participants
7.83  (5.53) 8.5  (6.15) 8.17  (5.86)
[1]
Measure Description:

The STS score is a validated risk-prediction model for open surgery based on data from the STS National Adult Cardiac Surgery Database. In general, an STS predicted risk of surgical mortality of 4%-8% is considered intermediate risk and 8% or greater is considered high risk.

As of November 15, 2018, The Society of Thoracic Surgeons released an updated short-term risk calculator to reflect the latest 2018 adult cardiac surgery risk models. The STS Calculator allows you to calculate a patient's risk of mortality and morbidities for the most commonly performed cardiac surgeries.

STS Risk Score >= 8%   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants 312 participants 614 participants
126
  41.7%
136
  43.6%
262
  42.7%
[1]
Measure Description:

The STS score is a validated risk-prediction model for open surgery based on data from the STS National Adult Cardiac Surgery Database. In general, an STS predicted risk of surgical mortality of 4%-8% is considered intermediate risk and 8% or greater is considered high risk.

As of November 15, 2018, The Society of Thoracic Surgeons released an updated short-term risk calculator to reflect the latest 2018 adult cardiac surgery risk models. The STS Calculator allows you to calculate a patient's risk of mortality and morbidities for the most commonly performed cardiac surgeries.

Risk of Surgery-related complications or death   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
High Number Analyzed 299 participants 312 participants 611 participants
205
  68.6%
218
  69.9%
423
  69.2%
Not High Number Analyzed 299 participants 312 participants 611 participants
94
  31.4%
94
  30.1%
188
  30.8%
[1]
Measure Description: Subjects were evaluated by the Local Site Heart Team based on their medical history to determine their risk of surgery related complications or death.
[2]
Measure Analysis Population Description: All available data is reported
Cardiomyopathy  
Measure Type: Count of Participants
Unit of measure:  Participants
Ischemic Number Analyzed 302 participants 312 participants 614 participants
184
  60.9%
189
  60.6%
373
  60.7%
Non-Ischemic Number Analyzed 302 participants 312 participants 614 participants
118
  39.1%
123
  39.4%
241
  39.3%
New York Heart Association (NYHA) Classification   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
NYHA Class I Number Analyzed 302 participants 312 participants 614 participants
1
   0.3%
0
   0.0%
1
   0.2%
NYHA Class II Number Analyzed 302 participants 312 participants 614 participants
129
  42.7%
110
  35.3%
239
  38.9%
NYHA Class III Number Analyzed 302 participants 312 participants 614 participants
154
  51.0%
168
  53.8%
322
  52.4%
NYHA Class IVa, ambulatory Number Analyzed 302 participants 312 participants 614 participants
18
   6.0%
33
  10.6%
51
   8.3%
[1]
Measure Description:

The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:

Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.

Class III - Marked limitation in activity due to symptoms Class IV - Severe limitations.

Hospitalization for Heart Failure within Previous 1 yr  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants 312 participants 614 participants
176
  58.3%
175
  56.1%
351
  57.2%
Previous Cardiac Resynchronization Therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants 312 participants 614 participants
115
  38.1%
109
  34.9%
224
  36.5%
Previous Implantation of Defibrillator  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 302 participants 312 participants 614 participants
91
  30.1%
101
  32.4%
192
  31.3%
Severity of Mitral Regurgitation   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Moderate-to-severe, grade 3+ Number Analyzed 302 participants 311 participants 613 participants
148
  49.0%
172
  55.3%
320
  52.2%
Severe, grade 4+ Number Analyzed 302 participants 311 participants 613 participants
154
  51.0%
139
  44.7%
293
  47.8%
[1]
Measure Analysis Population Description: In the Control group, baseline echocardiography data was not readable. Hence 311 participants were analyzed.
Effective Regurgitat Orifice Area   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm2
Number Analyzed 289 participants 302 participants 591 participants
0.41  (0.15) 0.40  (0.15) 0.41  (0.15)
[1]
Measure Analysis Population Description: EROA was not measurable for all subjects
Left Ventricular End Systolic Dimension (Diameter)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 301 participants 306 participants 607 participants
5.28  (0.86) 5.30  (0.89) 5.29  (0.87)
[1]
Measure Description: left ventricle end-systolic diameter, is measured at end systole, on the frame preceding mitral valve opening. It corresponds to the smallest cardiac dimension.
[2]
Measure Analysis Population Description: LVESD was not measurable for all subjects
Left Ventricular End-Diastolic Dimension   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 301 participants 307 participants 608 participants
6.17  (0.73) 6.19  (0.75) 6.18  (0.74)
[1]
Measure Analysis Population Description: LVEDD was not measurable in all subjects
Left Ventricular End-Systolic Volume   [1] 
Mean (Standard Deviation)
Unit of measure:  mL
Number Analyzed 281 participants 294 participants 575 participants
135.5  (56.1) 134.3  (60.3) 134.9  (58.2)
[1]
Measure Analysis Population Description: LVESV was not measurable for all subjects
Left Ventricular End-Diastolic Volume   [1] 
Mean (Standard Deviation)
Unit of measure:  mL
Number Analyzed 281 participants 294 participants 575 participants
194.4  (69.2) 191.0  (72.9) 192.7  (71.0)
[1]
Measure Analysis Population Description: LVEDV was not measurable in all subjects
Left Ventricular Ejection Fraction   [1] 
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 281 participants 294 participants 575 participants
31.32  (9.07) 31.30  (9.58) 31.31  (9.32)
[1]
Measure Analysis Population Description: LVEF was not measured for all subjects
LVEF >= 40%   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 281 participants 294 participants 575 participants
231
  82.2%
241
  82.0%
472
  82.1%
[1]
Measure Analysis Population Description: All available data is reported
Right Ventricular Systolic Pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 253 participants 275 participants 528 participants
43.95  (13.44) 44.56  (13.96) 44.26  (13.70)
[1]
Measure Analysis Population Description: All available data is reported
1.Primary Outcome
Title Primary Safety Endpoint - Percentage of Participants With Freedom From Device Related Complications at 12 Months
Hide Description

Percentage of Participants with Freedom from Device related Complications at 12 Months.

Composite of Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, LVAD implant, heart transplant, and any device related complications requiring non-elective cardiovascular surgery.

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who were randomized with attempted procedure to the device group with available data. Performance goal was 88%.
Arm/Group Title MitraClip System
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Overall Number of Participants Analyzed 293
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.966 [1] 
(0.948 to NA)
[1]
Upper limit is NA as this is a one sided 95% confidence interval.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MitraClip System
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Two thousand (2000) simulations were performed to calculate sample size and power for the primary safety endpoint. Assuming 22% mortality and 7.5% attrition at 12 months, a total of 305 subjects in the Device group will provide > 95% power to reject the null hypothesis at the one-sided significance level of 5%.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Z test Using Kaplan Meier Survival
Comments P-value calculated from Z test using Kaplan Meier survival estimate together with Greenwood method estimated variance
Method of Estimation Estimation Parameter Kaplan Meier
Estimated Value 0.966
Confidence Interval (1-Sided) 95%
0.948
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.011
Estimation Comments [Not Specified]
2.Primary Outcome
Title Primary Effectiveness Endpoint
Hide Description Recurrent HF hospitalizations (HFH) through 24 months, analyzed when the last subject completes 12-month follow-up
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
302 subjects from device group and 312 subjects from the control group were analyzed for Recurrent HF hospitalizations through 24 months
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 302 312
Measure Type: Number
Unit of Measure: events
160 283
3.Primary Outcome
Title Primary Effectiveness Endpoint
Hide Description Recurrent HF hospitalizations (HFH) through 24 months, analyzed when the last subject completes 12-month follow-up
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
302 subjects from device group and 312 subjects from the control group were analyzed for Recurrent HF hospitalizations through 24 months
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 302 312
Measure Type: Count of Participants
Unit of Measure: Participants
92 151
4.Secondary Outcome
Title Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)
Hide Description Number of recurrent Heart Failure hospitalization events at 12 months.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 157 subjects were enrolled in the COAPT CAS study.
Arm/Group Title MitraClip System
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Overall Number of Participants Analyzed 157
Measure Type: Number
Unit of Measure: Events
24
5.Secondary Outcome
Title New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis)
Hide Description

The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:

Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms Class IV - Severe limitations.

Time Frame 12 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title New York Heart Association (NYHA) Functional Class (COAPT CAS Study Analysis)
Hide Description

The New York Heart Association (NYHA) Classification provides a simple way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity:

Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms Class IV - Severe limitations.

Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 157 subjects were enrolled in the COAPT CAS study. Of them NYHA data was available for a total of 114 subjects at 30 days.
Arm/Group Title MitraClip System
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Overall Number of Participants Analyzed 114
Measure Type: Count of Participants
Unit of Measure: Participants
NYHA Class I
25
  21.9%
NYHA Class II
53
  46.5%
NYHA Class III
33
  28.9%
NYHA Class IV
3
   2.6%
7.Secondary Outcome
Title Quality of Life (QOL) (COAPT CAS Study Analysis) Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Hide Description

COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019.

Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.

Time Frame 12 months
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Quality of Life (QOL) (COAPT CAS Study Analysis) Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Hide Description The Kansas City Cardiomyopathy Questionnaire is a 23-item, self administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score. Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification. Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 157 subjects were enrolled in the COAPT CAS study. Data was available for 117 subjects at 30 days.
Arm/Group Title MitraClip System
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Overall Number of Participants Analyzed 117
Mean (Standard Deviation)
Unit of Measure: KCCQ score on a points scale
61.38  (25.21)
9.Secondary Outcome
Title Six Minute Walk Test (6MWT Distance or 6MWD) (COAPT CAS Study Analysis)
Hide Description

COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019.

Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.

Time Frame 12 months
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Six Minute Walk Test (6MWT Distance or 6MWD) (COAPT CAS Study Analysis)
Hide Description The Six Minute Walk Test (6MWT) is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 157 subjects were enrolled in the COAPT CAS study. 6MWT data was available for 98 subjects at 30 days..
Arm/Group Title MitraClip System
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Overall Number of Participants Analyzed 98
Mean (Standard Deviation)
Unit of Measure: meters
232.59  (145.67)
11.Secondary Outcome
Title Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis)
Hide Description

COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019.

Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.

Time Frame 12 months
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Mitral Regurgitation (MR) Severity (COAPT CAS Study Analysis)
Hide Description

MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below

MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was available for 120 subjects at 30 days.
Arm/Group Title MitraClip System
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Overall Number of Participants Analyzed 120
Measure Type: Count of Participants
Unit of Measure: Participants
None or Trace/Trivial
8
   6.7%
Mild (1+)
68
  56.7%
Moderate (2+)
35
  29.2%
Moderate - Severe (3+)
6
   5.0%
Severe (4+)
3
   2.5%
13.Secondary Outcome
Title Major and/or Life Threatening Bleeding (COAPT CAS Study Analysis)
Hide Description

COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019.

Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.

Time Frame 12 months
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Major and/or Life Threatening Bleeding (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MitraClip System
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Overall Number of Participants Analyzed 157
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.6%
15.Secondary Outcome
Title Major Vascular Complications (COAPT CAS Study Analysis)
Hide Description

COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019.

Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.

Time Frame 12 months
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Major Vascular Complications (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MitraClip System
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Overall Number of Participants Analyzed 157
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
17.Secondary Outcome
Title Renal Complication With Requirement for Dialysis (COAPT CAS Study Analysis)
Hide Description

COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019.

Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.

Time Frame 12 months
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Renal Complication With Requirement for Dialysis (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MitraClip System
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Overall Number of Participants Analyzed 157
Measure Type: Count of Participants
Unit of Measure: Participants
2
   1.3%
19.Secondary Outcome
Title Transient Ischemic Attack (TIA) (COAPT CAS Study Analysis)
Hide Description

COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019.

Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.

Time Frame 12 months
Outcome Measure Data Not Reported
20.Secondary Outcome
Title Transient Ischemic Attack (TIA) (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MitraClip System
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Overall Number of Participants Analyzed 157
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
21.Secondary Outcome
Title Stroke (COAPT CAS Study Analysis)
Hide Description

COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019.

Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.

Time Frame 12 months
Outcome Measure Data Not Reported
22.Secondary Outcome
Title Stroke (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MitraClip System
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Overall Number of Participants Analyzed 157
Measure Type: Count of Participants
Unit of Measure: Participants
1
   0.6%
23.Secondary Outcome
Title Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Hide Description

COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019.

Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.

Time Frame 12 months
Outcome Measure Data Not Reported
24.Secondary Outcome
Title Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MitraClip System
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Overall Number of Participants Analyzed 157
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
25.Secondary Outcome
Title Death and Primary Cause of Death (COAPT CAS Study Analysis)
Hide Description

COAPT Study is still on-going. Only the Primary and Major secondary endpoints were entered in the results section for the COAPT study after the FDA approval of the new indication. Subjects are still being followed in both the COAPT and COAPT CAS cohorts. COAPT CAS study is a single arm registry that will provide valuable new information regarding use of the MitraClip NT system under more "real world" conditions. COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019.

Remainder of the COAPT and COAPT CAS results will be entered when the study is closed.

Time Frame 12 months
Outcome Measure Data Not Reported
26.Secondary Outcome
Title Death and Primary Cause of Death (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MitraClip System
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Overall Number of Participants Analyzed 157
Measure Type: Count of Participants
Unit of Measure: Participants
Cardiac
2
   1.3%
Neurologic
0
   0.0%
Renal
0
   0.0%
Vascular
0
   0.0%
Infection
0
   0.0%
Valvular
0
   0.0%
Unknown
1
   0.6%
Other
0
   0.0%
27.Secondary Outcome
Title Percentage of Patients Free From the Composite of All-cause Death, Stroke, MI, or Non-elective Cardiovascular Surgery for Device Related Complications in the Device Group
Hide Description The percentage of patients free from the composite endpoint as described above.
Time Frame 30 days post-procedure in the Device group
Hide Outcome Measure Data
Hide Analysis Population Description
All device subjects
Arm/Group Title MitraClip System
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Overall Number of Participants Analyzed 302
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
96.9
(94.7 to 96.9)
28.Secondary Outcome
Title Number of Deaths at 12 Months (All Cause Mortality)
Hide Description Death from any cause mortality at 12months.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All device and control group subjects were included in the analysis.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 302 312
Measure Type: Number
Unit of Measure: participants
57 70
29.Secondary Outcome
Title Number of Participants With Mitral Regurgitation Severity Grade of 2+ or Lower at 12 Months
Hide Description

MR severity grade of 2+ or lower at 12 months MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below

MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiography data was available for 210 subjects in Device group and 175 subjects in Control group
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 210 175
Measure Type: Count of Participants
Unit of Measure: Participants
199
  94.8%
82
  46.9%
30.Secondary Outcome
Title Change in Distance Walked on the 6 Minute Walk Test (6MWT Distance or 6MWD)
Hide Description The 6MWT is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism. It does not provide specific information on the function of each of the different organs and systems involved in exercise or the mechanism of exercise limitation, as is possible with maximal cardiopulmonary exercise testing. The self-paced 6MWT assesses the submaximal level of functional capacity.
Time Frame 12 months over baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes subjects still active and with paired available compared to baseline.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 230 237
Mean (Standard Deviation)
Unit of Measure: meters
-2.17  (9.12) -60.2  (8.99)
31.Secondary Outcome
Title Change in Quality of Life (QoL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Hide Description

Paired data looking at difference between the baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) and 12 month KCCQ score.

The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The KCCQ tool quantifies the following six (6) distinct domains and two (2) summary scores: KCCQ Symptom Domain, KCCQ Physical Function Domain, KCCQ Quality of Life Domain, KCCQ Social Limitation Domain, KCCQ Self-efficacy Domain, KCCQ Symptom Stability Domain, Clinical Summary Score and Overall Summary Score.

Clinical Summary Score includes total symptom and physical function scores to correspond with NYHA Classification.

Overall Summary Score includes the total symptom, physical function, social limitations and quality of life scores.

Time Frame 12 months over baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes subjects still active and with paired available compared to baseline.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 237 228
Mean (Standard Deviation)
Unit of Measure: KCCQ Score on a points scale
12.5  (1.8) -3.6  (1.9)
32.Secondary Outcome
Title Change in Left Ventricular End Diastolic Volume (LVEDV)
Hide Description Paired data comparing the Change in LVEDV at baseline vs 12 months
Time Frame 12 months over baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes subjects with echocardiography paired data available
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 175 174
Mean (Standard Deviation)
Unit of Measure: mL
-3.71  (5.08) 17.06  (5.10)
33.Secondary Outcome
Title Number of Participants With New York Heart Association (NYHA) Functional Class I/II
Hide Description

NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA CLASS)

Class I: Patients with cardiac disease but without resulting limitations of physical activity.

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Patients are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

Class IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes subjects with available NYHA class data at 12 months
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 237 232
Measure Type: Count of Participants
Unit of Measure: Participants
171
  72.2%
115
  49.6%
34.Secondary Outcome
Title Recurrent Hospitalizations - All Cause
Hide Description Number of Recurrent Hospitalizations for any cause within 24 months.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects in Device and Control Group
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 302 312
Measure Type: Number
Unit of Measure: Number of Events
474 610
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MitraClip System, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.02
Comments [Not Specified]
Method Joint Fraility Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.60 to 0.96
Estimation Comments [Not Specified]
35.Secondary Outcome
Title Death or HF Hospitalization Within 24 Months (Finkelstein-Schoenfeld Analysis of All-Cause Death or Recurrent HF Hospitalization Through 24 Months)
Hide Description

The win ratio is a useful method for providing an estimate of the treatment effect when composite endpoints are analyzed as the analysis accounts for clinical significance of the outcomes of interest. For example, in the composite of death and recurrent HF hospitalizations through 24 months, subjects in the Device and Control groups were formed into matched pairs, where each pair of subjects was classified into 1 of 5 outcomes scenarios:

A. Death in Device group first B. Death in Control group first C. More HF hospitalizations in the Device group (or in the case of a tie, the first HF hospitalization in the Device group occurs first) D. More HF hospitalization in the Control group (or in the case of tie, the first HF hospitalization in the Control group occurs first) E. None of the above In this way, the number of "Winners" in the Device group was NW = NB + ND while the number of "Losers" in the Device group was NL = NA + NC. The "Win Ratio" was then calculated as NW/NL.

Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Randomized Group
Hide Arm/Group Description:
Randomized group contains both Device and Control Group
Overall Number of Participants Analyzed 614
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Win Ratio
1.61
(1.29 to 2.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Finkelstein-Schoenfeld Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Win Ratio
Estimated Value 1.61
Confidence Interval (2-Sided) 95%
1.29 to 2.04
Estimation Comments [Not Specified]
36.Secondary Outcome
Title Death and Primary Cause of Death (COAPT CAS Study Analysis)
Hide Description The COAPT study is still on-going. Only the Primary and major secondary endpoints have been entered. Rest of the results will be entered when the study ends in July 2024.
Time Frame 2 years
Outcome Measure Data Not Reported
37.Secondary Outcome
Title Death and Primary Cause of Death (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 3 years
Outcome Measure Data Not Reported
38.Secondary Outcome
Title Death and Primary Cause of Death (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 4 years
Outcome Measure Data Not Reported
39.Secondary Outcome
Title Death and Primary Cause of Death (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
40.Secondary Outcome
Title Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 2 years
Outcome Measure Data Not Reported
41.Secondary Outcome
Title Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 3 years
Outcome Measure Data Not Reported
42.Secondary Outcome
Title Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 4 years
Outcome Measure Data Not Reported
43.Secondary Outcome
Title Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
44.Secondary Outcome
Title Stroke (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 2 years
Outcome Measure Data Not Reported
45.Secondary Outcome
Title Stroke (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 3 years
Outcome Measure Data Not Reported
46.Secondary Outcome
Title Stroke (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 4 years
Outcome Measure Data Not Reported
47.Secondary Outcome
Title Stroke (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
48.Secondary Outcome
Title Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 2 years
Outcome Measure Data Not Reported
49.Secondary Outcome
Title Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 3 years
Outcome Measure Data Not Reported
50.Secondary Outcome
Title Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 4 years
Outcome Measure Data Not Reported
51.Secondary Outcome
Title Recurrent Heart Failure (HF) Hospitalization (COAPT CAS Study Analysis)
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
52.Secondary Outcome
Title Kaplan-Meier Freedom From All-cause Mortality
Hide Description Death from any cause within 24 months - no of events
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Total number of subjects randomized in the Device and Control group
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 302 312
Measure Type: Number
Unit of Measure: no of events
83 125
53.Other Pre-specified Outcome
Title Device or Procedure-Related Adverse Events
Hide Description Device or procedure-related adverse events are defined as adverse events that are adjudicated by the Clinical Events Committee as possibly, probably or definitely device and/or procedure-related, regardless of the temporal relationship to the MitraClip procedure. Device or procedure-related adverse events will be broken down into those that occur within 30 days of the procedure and those that occur after 30 days of the procedure. Examples of device-related adverse events are: myocardial perforation, Single Leaflet Device Attachment, embolization of the MitraClip device or MitraClip System components, iatrogenic atrial septal defect, mitral valve stenosis, need for mitral valve replacement instead of repair due at least in part to the MitraClip procedure or the presence of the MitraClip device.
Time Frame Within and after 30 days of the procedure
Hide Outcome Measure Data
Hide Analysis Population Description
All available data has been reported.
Arm/Group Title MitraClip System
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Overall Number of Participants Analyzed 302
Measure Type: Count of Participants
Unit of Measure: Participants
Occurred within 30 days
17
   5.6%
Occurred between 31 days and 365 days
4
   1.3%
54.Other Pre-specified Outcome
Title Implant Rate
Hide Description Defined as the rate of successful delivery and deployment of the MitraClip device(s) with echocardiographic evidence of leaflet approximation and retrieval of the delivery catheter
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects randomized to the device arm
Arm/Group Title MitraClip System
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Overall Number of Participants Analyzed 302
Measure Type: Count of Participants
Unit of Measure: Participants
287
  95.0%
55.Other Pre-specified Outcome
Title Device Procedure Time
Hide Description Defined as the time elapsed from the start of the transseptal procedure to the time the Steerable Guide Catheter is removed
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Device procedure time was not available for all implanted subjects. Data was available for 282 subjects from 302 randomized subjects in device arm.
Arm/Group Title MitraClip System
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Overall Number of Participants Analyzed 282
Mean (Standard Deviation)
Unit of Measure: minutes
118.9  (63.5)
56.Other Pre-specified Outcome
Title Total Procedure Time
Hide Description Defined as the time elapsed from the first of any of the following: intravascular catheter placement, anesthesia or sedation, or transesophageal echocardiogram (TEE), to the removal of the last catheter and TEE
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Total procedure time was available for 293 subjects from the 302 subjects randomized to device arm.
Arm/Group Title MitraClip System
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Overall Number of Participants Analyzed 293
Mean (Standard Deviation)
Unit of Measure: minutes
162.9  (118.1)
57.Other Pre-specified Outcome
Title Device Time
Hide Description Defined as the time the Steerable Guide Catheter is placed in the intra-atrial septum until the time the MitraClip Delivery System (CDS) is retracted into the Steerable Guide Catheter
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Device time available for all 287 subjects implanted with MitraClip.
Arm/Group Title MitraClip System
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Overall Number of Participants Analyzed 287
Mean (Standard Deviation)
Unit of Measure: minutes
82.7  (80.8)
58.Other Pre-specified Outcome
Title Fluoroscopy Duration
Hide Description Defined as the duration of exposure to fluoroscopy during the MitraClip procedure
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Fluoroscopy duration for all available subjects with MitraClip device
Arm/Group Title MitraClip System
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Overall Number of Participants Analyzed 284
Mean (Standard Deviation)
Unit of Measure: minutes
33.9  (23.2)
59.Other Pre-specified Outcome
Title MR Severity Grade
Hide Description

MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below

MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
echocardiogram data was available for 302 subjects in the device arm and 311 subjects in the control arm.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 302 311
Measure Type: Count of Participants
Unit of Measure: Participants
MR 3+
148
  49.0%
172
  55.3%
MR 4+
154
  51.0%
139
  44.7%
60.Other Pre-specified Outcome
Title MR Severity Grade
Hide Description

MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below

MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

Time Frame At discharge (or 30 days if discharge echocardiogram is not available)
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was available for 286 subjects in the device arm and 257 subjects in the control arm.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 286 257
Measure Type: Count of Participants
Unit of Measure: Participants
MR None or 1+
230
  80.4%
21
   8.2%
MR 2+
39
  13.6%
67
  26.1%
MR 3+
13
   4.5%
96
  37.4%
MR 4+
4
   1.4%
73
  28.4%
61.Other Pre-specified Outcome
Title MR Severity Grade
Hide Description

MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below

MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was available for only 240 subjects in the device group and 218 subjects in the control group
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 240 218
Measure Type: Count of Participants
Unit of Measure: Participants
MR none or 1+
160
  66.7%
20
   9.2%
MR 2+
65
  27.1%
63
  28.9%
MR 3+
11
   4.6%
92
  42.2%
MR 4+
4
   1.7%
43
  19.7%
62.Other Pre-specified Outcome
Title MR Severity Grade
Hide Description

MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below

MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was available for 210 subjects in the device arm and 175 subjects in the control arm.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 210 175
Measure Type: Count of Participants
Unit of Measure: Participants
MR None or 1+
145
  69.0%
20
  11.4%
MR 2+
54
  25.7%
62
  35.4%
MR 3+
9
   4.3%
60
  34.3%
MR 4+
2
   1.0%
33
  18.9%
63.Other Pre-specified Outcome
Title MR Severity Grade
Hide Description

MR Severity Grading was done by Quantitative Doppler Echocardiography and subjects were graded as below

MR 1+ - Regurgitant Volume < 30 ml, Right ventricular EF <30%, Effective regurgitant orifice area < 20 mm^2 MR 2+ - Regurgitant Volume 30-44 ml, Right ventricular EF 30-39%, Effective regurgitant orifice area 20-29 mm^2 MR 3+ - Regurgitant Volume 45-59 ml, Right ventricular EF 40-49 %, Effective regurgitant orifice area 30-39 mm^2 MR 4+ - Regurgitant Volume >= 60 ml, Right ventricular EF >=50%, Effective regurgitant orifice area >=40 mm^2

Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was available for 162 subjects in the device arm and 124 subjects in the control arm.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 162 124
Measure Type: Count of Participants
Unit of Measure: Participants
MR None or 1+
127
  78.4%
23
  18.5%
MR 2+
34
  21.0%
34
  27.4%
MR 3+
0
   0.0%
43
  34.7%
MR 4+
1
   0.6%
24
  19.4%
64.Other Pre-specified Outcome
Title MR Severity Grade
Hide Description [Not Specified]
Time Frame 3 years
Outcome Measure Data Not Reported
65.Other Pre-specified Outcome
Title MR Severity Grade
Hide Description [Not Specified]
Time Frame 4 years
Outcome Measure Data Not Reported
66.Other Pre-specified Outcome
Title MR Severity Grade
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
67.Other Pre-specified Outcome
Title Effective Regurgitant Orifice Area
Hide Description Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was available for the 289 subjects in the device arm and 302 subjects in the control arm.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 289 302
Mean (Standard Deviation)
Unit of Measure: cm^2
0.41  (0.15) 0.40  (0.15)
68.Other Pre-specified Outcome
Title Effective Regurgitant Orifice Area
Hide Description Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time Frame At discharge (or 30 days if discharge echocardiogram is not available)
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was available for 75 subjects in the device arm and 73 subjects in the control arm.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 75 73
Mean (Standard Deviation)
Unit of Measure: cm^2
0.14  (0.08) 0.23  (0.16)
69.Other Pre-specified Outcome
Title Effective Regurgitant Orifice Area
Hide Description Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was available for 39 subjects in the device arm and 54 subjects in the control arm
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 39 54
Mean (Standard Deviation)
Unit of Measure: cm^2
0.22  (0.19) 0.25  (0.14)
70.Other Pre-specified Outcome
Title Effective Regurgitant Orifice Area
Hide Description Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was available for 39 subjects in the device arm and 46 subjects in the control arm
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 39 46
Mean (Standard Deviation)
Unit of Measure: cm^2
0.18  (0.12) 0.26  (0.19)
71.Other Pre-specified Outcome
Title Effective Regurgitant Orifice Area
Hide Description Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was available for 18 subjects in the device arm and 24 subjects in the control arm
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 18 24
Mean (Standard Deviation)
Unit of Measure: cm^2
0.15  (0.09) 0.26  (0.12)
72.Other Pre-specified Outcome
Title Effective Regurgitant Orifice Area
Hide Description [Not Specified]
Time Frame 3 years
Outcome Measure Data Not Reported
73.Other Pre-specified Outcome
Title Effective Regurgitant Orifice Area
Hide Description [Not Specified]
Time Frame 4 years
Outcome Measure Data Not Reported
74.Other Pre-specified Outcome
Title Effective Regurgitant Orifice Area
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
75.Other Pre-specified Outcome
Title Regurgitant Volume
Hide Description Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was available for 124 subjects in the device arm and 136 subjects in the control arm.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 124 136
Mean (Standard Deviation)
Unit of Measure: ml/beat
28.80  (16.99) 25.01  (15.31)
76.Other Pre-specified Outcome
Title Regurgitant Volume
Hide Description Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.
Time Frame At discharge (or 30 days if discharge echocardiogram is not available)
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was available for 85 subjects in device arm and 70 subjects in control arm
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 85 70
Mean (Standard Deviation)
Unit of Measure: ml/beat
20.04  (11.86) 25.97  (15.68)
77.Other Pre-specified Outcome
Title Regurgitant Volume
Hide Description Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was available for 45 subjects in the device arm and 54 subjects in the control arm.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 45 54
Mean (Standard Deviation)
Unit of Measure: ml/beat
23.60  (16.00) 32.59  (15.82)
78.Other Pre-specified Outcome
Title Regurgitant Volume
Hide Description Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was available for 33 subjects in the device arm and 45 subjects in the control arm.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 33 45
Mean (Standard Deviation)
Unit of Measure: ml/beat
21.61  (12.12) 27.76  (14.35)
79.Other Pre-specified Outcome
Title Regurgitant Volume
Hide Description Regurgitant Volume is calculated by subtracting the inflow volume across the mitral valve during diastole from the Left Ventricular Outflow Tract (LVOT) stroke volume during systole.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was available for 20 subjects in the device arm and 27 subjects in the control arm
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 20 27
Mean (Standard Deviation)
Unit of Measure: ml/beat
21.10  (11.50) 33.37  (16.20)
80.Other Pre-specified Outcome
Title Regurgitant Volume
Hide Description [Not Specified]
Time Frame 3 years
Outcome Measure Data Not Reported
81.Other Pre-specified Outcome
Title Regurgitant Volume
Hide Description [Not Specified]
Time Frame 4 years
Outcome Measure Data Not Reported
82.Other Pre-specified Outcome
Title Regurgitant Volume
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
83.Other Pre-specified Outcome
Title Regurgitant Fraction
Hide Description Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was available for 123 subjects in the device group and 136 subjects in the control group.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 123 136
Mean (Standard Deviation)
Unit of Measure: percentage
38.24  (13.81) 34.81  (14.94)
84.Other Pre-specified Outcome
Title Regurgitant Fraction
Hide Description Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.
Time Frame At discharge (or 30 days if discharge echocardiogram is not available)
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was available for 85 subjects in the device arm and 70 subjects in the control arm.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 85 70
Mean (Standard Deviation)
Unit of Measure: percentage
31.00  (14.53) 35.29  (15.32)
85.Other Pre-specified Outcome
Title Regurgitant Fraction
Hide Description Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was available for 45 subjects in the device arm and 54 subjects in the control arm
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 45 54
Mean (Standard Deviation)
Unit of Measure: percentage
34.14  (15.89) 42.20  (14.49)
86.Other Pre-specified Outcome
Title Regurgitant Fraction
Hide Description Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data was available for 33 subjects in the device arm and 45 subjects in the control arm.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 33 45
Mean (Standard Deviation)
Unit of Measure: percentage
32.15  (13.06) 37.80  (15.49)
87.Other Pre-specified Outcome
Title Regurgitant Fraction
Hide Description Regurgitant fraction is the percentage of blood that regurgitates back through the aortic valve to the left ventricle due to aortic insufficiency, or through the mitral valve to the atrium due to mitral insufficiency.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Echocardiogram data is available for 20 subjects in the device arm and 27 subjects in the control arm.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 20 27
Mean (Standard Deviation)
Unit of Measure: percentage
33.50  (14.43) 42.23  (15.03)
88.Other Pre-specified Outcome
Title Regurgitant Fraction
Hide Description [Not Specified]
Time Frame 3 years
Outcome Measure Data Not Reported
89.Other Pre-specified Outcome
Title Regurgitant Fraction
Hide Description [Not Specified]
Time Frame 4 years
Outcome Measure Data Not Reported
90.Other Pre-specified Outcome
Title Regurgitant Fraction
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
91.Other Pre-specified Outcome
Title Left Ventricle End Diastolic Volume (LVEDV)
Hide Description Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data used for analysis.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 281 294
Mean (Standard Deviation)
Unit of Measure: mL
194.4  (69.2) 191.0  (72.9)
92.Other Pre-specified Outcome
Title Left Ventricle End Diastolic Volume (LVEDV)
Hide Description Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.
Time Frame At discharge (or 30 days if discharge echocardiogram is not available)
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been presented.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 259 223
Mean (Standard Deviation)
Unit of Measure: mL
176.0  (64.6) 179.1  (68.4)
93.Other Pre-specified Outcome
Title Left Ventricle End Diastolic Volume (LVEDV)
Hide Description Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been presented.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 200 171
Mean (Standard Deviation)
Unit of Measure: mL
181.4  (65.1) 182.6  (72.4)
94.Other Pre-specified Outcome
Title Left Ventricle End Diastolic Volume (LVEDV)
Hide Description Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been presented.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 168 146
Mean (Standard Deviation)
Unit of Measure: mL
179.4  (66.2) 176.3  (65.1)
95.Other Pre-specified Outcome
Title Left Ventricle End Diastolic Volume (LVEDV)
Hide Description Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been presented
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 116 92
Mean (Standard Deviation)
Unit of Measure: mL
176.0  (60.8) 185.7  (73.8)
96.Other Pre-specified Outcome
Title Left Ventricle End Diastolic Volume (LVEDV)
Hide Description [Not Specified]
Time Frame 3 years
Outcome Measure Data Not Reported
97.Other Pre-specified Outcome
Title Left Ventricle End Diastolic Volume (LVEDV)
Hide Description [Not Specified]
Time Frame 4 years
Outcome Measure Data Not Reported
98.Other Pre-specified Outcome
Title Left Ventricle End Diastolic Volume (LVEDV)
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
99.Other Pre-specified Outcome
Title Left Ventricular End Systolic Volume (LVESV)
Hide Description Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been presented.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 281 294
Mean (Standard Deviation)
Unit of Measure: mL
135.5  (56.1) 134.3  (60.3)
100.Other Pre-specified Outcome
Title Left Ventricular End Systolic Volume (LVESV)
Hide Description Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.
Time Frame At discharge (or 30 days if discharge echocardiogram is not available)
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been presented.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 258 223
Mean (Standard Deviation)
Unit of Measure: mL
129.3  (56.5) 125.7  (57.1)
101.Other Pre-specified Outcome
Title Left Ventricular End Systolic Volume (LVESV)
Hide Description Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been presented.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 200 171
Mean (Standard Deviation)
Unit of Measure: mL
133.1  (59.2) 129.1  (59.2)
102.Other Pre-specified Outcome
Title Left Ventricular End Systolic Volume (LVESV)
Hide Description Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been presented.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 168 146
Mean (Standard Deviation)
Unit of Measure: mL
133.0  (60.9) 125.9  (54.8)
103.Other Pre-specified Outcome
Title Left Ventricular End Systolic Volume (LVESV)
Hide Description Left Ventricular End-systolic volume (LVESV) is the volume of blood in the left ventricle at the end of contraction, or systole, and the beginning of filling, or diastole. LVESV is the lowest volume of blood in the left ventricle at any point in the cardiac cycle.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been presented.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 116 92
Mean (Standard Deviation)
Unit of Measure: mL
128.2  (52.9) 133.2  (65.1)
104.Other Pre-specified Outcome
Title Left Ventricular End Systolic Volume (LVESV)
Hide Description [Not Specified]
Time Frame 3 years
Outcome Measure Data Not Reported
105.Other Pre-specified Outcome
Title Left Ventricular End Systolic Volume (LVESV)
Hide Description [Not Specified]
Time Frame 4 years
Outcome Measure Data Not Reported
106.Other Pre-specified Outcome
Title Left Ventricular End Systolic Volume (LVESV)
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
107.Other Pre-specified Outcome
Title Left Ventricular End Diastolic Dimension (LVEDD)
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been presented.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 301 307
Mean (Standard Deviation)
Unit of Measure: cm
6.17  (0.73) 6.19  (0.75)
108.Other Pre-specified Outcome
Title Left Ventricular End Diastolic Dimension (LVEDD)
Hide Description [Not Specified]
Time Frame At discharge (or 30 days if discharge echocardiogram is not available)
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been presented.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 286 249
Mean (Standard Deviation)
Unit of Measure: cm
6.10  (0.75) 7.41  (19.58)
109.Other Pre-specified Outcome
Title Left Ventricular End Diastolic Dimension (LVEDD)
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been presented.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 231 210
Mean (Standard Deviation)
Unit of Measure: cm
6.12  (0.77) 6.15  (0.81)
110.Other Pre-specified Outcome
Title Left Ventricular End Diastolic Dimension (LVEDD)
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been presented.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 198 174
Mean (Standard Deviation)
Unit of Measure: cm
6.08  (0.77) 6.10  (0.83)
111.Other Pre-specified Outcome
Title Left Ventricular End Diastolic Dimension (LVEDD)
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been presented.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 152 124
Mean (Standard Deviation)
Unit of Measure: cm
6.07  (0.92) 6.19  (0.88)
112.Other Pre-specified Outcome
Title Left Ventricular End Diastolic Dimension (LVEDD)
Hide Description [Not Specified]
Time Frame 3 years
Outcome Measure Data Not Reported
113.Other Pre-specified Outcome
Title Left Ventricular End Diastolic Dimension (LVEDD)
Hide Description [Not Specified]
Time Frame 4 years
Outcome Measure Data Not Reported
114.Other Pre-specified Outcome
Title Left Ventricular End Diastolic Dimension (LVEDD)
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
115.Other Pre-specified Outcome
Title Left Ventricular End Systolic Dimension (LVESD)
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been reported.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 301 306
Mean (Standard Deviation)
Unit of Measure: cm
5.28  (0.86) 5.30  (0.89)
116.Other Pre-specified Outcome
Title Left Ventricular End Systolic Dimension (LVESD)
Hide Description [Not Specified]
Time Frame At discharge (or 30 days if discharge echocardiogram is not available)
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been reported.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 286 248
Mean (Standard Deviation)
Unit of Measure: cm
5.31  (0.89) 6.12  (12.64)
117.Other Pre-specified Outcome
Title Left Ventricular End Systolic Dimension (LVESD)
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been reported.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 231 208
Mean (Standard Deviation)
Unit of Measure: cm
5.34  (0.91) 5.28  (0.96)
118.Other Pre-specified Outcome
Title Left Ventricular End Systolic Dimension (LVESD)
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been reported.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 197 173
Mean (Standard Deviation)
Unit of Measure: cm
5.26  (0.95) 5.25  (0.99)
119.Other Pre-specified Outcome
Title Left Ventricular End Systolic Dimension (LVESD)
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been reported.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 151 121
Mean (Standard Deviation)
Unit of Measure: cm
5.24  (1.08) 5.27  (1.02)
120.Other Pre-specified Outcome
Title Left Ventricular End Systolic Dimension (LVESD)
Hide Description [Not Specified]
Time Frame 3 years
Outcome Measure Data Not Reported
121.Other Pre-specified Outcome
Title Left Ventricular End Systolic Dimension (LVESD)
Hide Description [Not Specified]
Time Frame 4 years
Outcome Measure Data Not Reported
122.Other Pre-specified Outcome
Title Left Ventricular End Systolic Dimension (LVESD)
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
123.Other Pre-specified Outcome
Title Left Ventricular Ejection Fraction (LVEF)
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been reported.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 281 294
Mean (Standard Deviation)
Unit of Measure: percentage
31.32  (9.07) 31.30  (9.58)
124.Other Pre-specified Outcome
Title Left Ventricular Ejection Fraction (LVEF)
Hide Description [Not Specified]
Time Frame At discharge (or 30 days if discharge echocardiogram is not available)
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been reported.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 259 223
Mean (Standard Deviation)
Unit of Measure: percentage
27.88  (8.84) 31.11  (10.45)
125.Other Pre-specified Outcome
Title Left Ventricular Ejection Fraction (LVEF)
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been reported.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 200 171
Mean (Standard Deviation)
Unit of Measure: percentage
28.38  (10.45) 30.44  (10.15)
126.Other Pre-specified Outcome
Title Left Ventricular Ejection Fraction (LVEF)
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been reported.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 168 146
Mean (Standard Deviation)
Unit of Measure: percentage
27.74  (11.31) 29.72  (10.06)
127.Other Pre-specified Outcome
Title Left Ventricular Ejection Fraction (LVEF)
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been reported.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 116 92
Mean (Standard Deviation)
Unit of Measure: percentage
28.2  (9.2) 30.64  (12.27)
128.Other Pre-specified Outcome
Title Left Ventricular Ejection Fraction (LVEF)
Hide Description [Not Specified]
Time Frame 3 years
Outcome Measure Data Not Reported
129.Other Pre-specified Outcome
Title Left Ventricular Ejection Fraction (LVEF)
Hide Description [Not Specified]
Time Frame 4 years
Outcome Measure Data Not Reported
130.Other Pre-specified Outcome
Title Left Ventricular Ejection Fraction (LVEF)
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
131.Other Pre-specified Outcome
Title Right Ventricular Systolic Pressure (RVSP)
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been reported.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 253 275
Mean (Standard Deviation)
Unit of Measure: mmHg
43.95  (13.44) 44.56  (13.96)
132.Other Pre-specified Outcome
Title Right Ventricular Systolic Pressure (RVSP)
Hide Description [Not Specified]
Time Frame At discharge (or 30 days if discharge echocardiogram is not available)
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been reported.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 257 239
Mean (Standard Deviation)
Unit of Measure: mmHg
41.41  (11.63) 43.81  (14.24)
133.Other Pre-specified Outcome
Title Right Ventricular Systolic Pressure (RVSP)
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been reported.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 196 188
Mean (Standard Deviation)
Unit of Measure: mmHg
40.96  (13.06) 42.21  (14.19)
134.Other Pre-specified Outcome
Title Right Ventricular Systolic Pressure (RVSP)
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been reported.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 170 144
Mean (Standard Deviation)
Unit of Measure: mmHg
38.63  (13.00) 39.31  (13.24)
135.Other Pre-specified Outcome
Title Right Ventricular Systolic Pressure (RVSP)
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All available echocardiogram data has been reported.
Arm/Group Title MitraClip System Control Group
Hide Arm/Group Description:

Percutaneous mitral valve repair using MitraClip System

MitraClip System: Percutaneous mitral valve repair using MitraClip System

Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Overall Number of Participants Analyzed 123 98
Mean (Standard Deviation)
Unit of Measure: mmHg
39.67  (12.94) 40.38  (14.95)
136.Other Pre-specified Outcome
Title Right Ventricular Systolic Pressure (RVSP)
Hide Description [Not Specified]
Time Frame 3 years
Outcome Measure Data Not Reported
137.Other Pre-specified Outcome
Title Right Ventricular Systolic Pressure (RVSP)
Hide Description [Not Specified]
Time Frame 4 years
Outcome Measure Data Not Reported
138.Other Pre-specified Outcome
Title Right Ventricular Systolic Pressure (RVSP)
Hide Description [Not Specified]
Time Frame 5 years
Outcome Measure Data Not Reported
139.Other Pre-specified Outcome
Title Mitral Valve Area
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data