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

• ClinicalTrials.gov Identifier: NCT01626079
• Recruitment Status: Active, not recruiting
• First Posted: June 22, 2012
• Results First Posted: May 6, 2020
• Last Update Posted: January 8, 2021
• Sponsor: Abbott Medical Devices
• 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

Participant Flow

Recruitment Details	In COAPT, 614 subjects were randomized. Enrollment concluded on June 23, 2017. Of the 614 randomized subjects, 302 were in Device group and 312 in the Control group. Subject follow-up is 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
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

Baseline Characteristics

Arm/Group Title		MitraClip System	Control Group	Total
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
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: Porcelain aorta or mobile ascending aortic atheroma; Post-radiation mediastinum; Previous mediastinitis; Functional MR with EF < 40%; Over 75 years old with EF < 40%; Prior re-operation with patent grafts; Two or more prior chest surgeries; Hepatic cirrhosis; 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

Outcome Measures

1. Primary Outcome

Title	Primary Safety Endpoint - Percentage of Participants With Freedom From Device Related Complications at 12 Months
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

Outcome Measure Data

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
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.

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
Description	Recurrent HF hospitalizations (HFH) through 24 months, analyzed when the last subject completes 12-month follow-up
Time Frame	24 months

Outcome Measure Data

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
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
Description	Recurrent HF hospitalizations (HFH) through 24 months, analyzed when the last subject completes 12-month follow-up
Time Frame	24 months

Outcome Measure Data

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
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)
Description	Number of recurrent Heart Failure hospitalization events at 12 months.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

A total of 157 subjects were enrolled in the COAPT CAS study.

Arm/Group Title	MitraClip System
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)
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)
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

Outcome Measure Data

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
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)
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)
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

Outcome Measure Data

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
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)
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)
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

Outcome Measure Data

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
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)
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)
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

Outcome Measure Data

Analysis Population Description

Echocardiogram data was available for 120 subjects at 30 days.

Arm/Group Title	MitraClip System
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)
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)
Description	[Not Specified]
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System
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)
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)
Description	[Not Specified]
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System
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)
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)
Description	[Not Specified]
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System
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)
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)
Description	[Not Specified]
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System
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)
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)
Description	[Not Specified]
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System
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)
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)
Description	[Not Specified]
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System
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)
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)
Description	[Not Specified]
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MitraClip System
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
Description	The percentage of patients free from the composite endpoint as described above.
Time Frame	30 days post-procedure in the Device group

Outcome Measure Data

Analysis Population Description

All device subjects

Arm/Group Title	MitraClip System
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)
Description	Death from any cause mortality at 12months.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All device and control group subjects were included in the analysis.

Arm/Group Title	MitraClip System	Control Group
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
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

Analysis Population Description

Analysis population includes subjects still active and with paired available compared to baseline.

Arm/Group Title	MitraClip System	Control Group
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)
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

Outcome Measure Data

Analysis Population Description

Analysis population includes subjects still active and with paired available compared to baseline.

Arm/Group Title	MitraClip System	Control Group
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)
Description	Paired data comparing the Change in LVEDV at baseline vs 12 months
Time Frame	12 months over baseline

Outcome Measure Data

Analysis Population Description

Analysis population includes subjects with echocardiography paired data available

Arm/Group Title	MitraClip System	Control Group
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
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

Outcome Measure Data

Analysis Population Description

Analysis population includes subjects with available NYHA class data at 12 months

Arm/Group Title	MitraClip System	Control Group
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
Description	Number of Recurrent Hospitalizations for any cause within 24 months.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

All randomized subjects in Device and Control Group

Arm/Group Title	MitraClip System	Control Group
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

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)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Randomized Group
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)

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)
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)
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)
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)
Description	[Not Specified]
Time Frame	5 years

Outcome Measure Data Not Reported

40. Secondary Outcome

Title	Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Description	[Not Specified]
Time Frame	2 years

Outcome Measure Data Not Reported

41. Secondary Outcome

Title	Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Description	[Not Specified]
Time Frame	3 years

Outcome Measure Data Not Reported

42. Secondary Outcome

Title	Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Description	[Not Specified]
Time Frame	4 years

Outcome Measure Data Not Reported

43. Secondary Outcome

Title	Myocardial Infarction (MI) (COAPT CAS Study Analysis)
Description	[Not Specified]
Time Frame	5 years

Outcome Measure Data Not Reported

44. Secondary Outcome

Title	Stroke (COAPT CAS Study Analysis)
Description	[Not Specified]
Time Frame	2 years

Outcome Measure Data Not Reported

45. Secondary Outcome

Title	Stroke (COAPT CAS Study Analysis)
Description	[Not Specified]
Time Frame	3 years

Outcome Measure Data Not Reported

46. Secondary Outcome

Title	Stroke (COAPT CAS Study Analysis)
Description	[Not Specified]
Time Frame	4 years

Outcome Measure Data Not Reported

47. Secondary Outcome

Title	Stroke (COAPT CAS Study Analysis)
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)
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)
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)
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)
Description	[Not Specified]
Time Frame	5 years

Outcome Measure Data Not Reported

52. Secondary Outcome

Title	Kaplan-Meier Freedom From All-cause Mortality
Description	Death from any cause within 24 months - no of events
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Total number of subjects randomized in the Device and Control group

Arm/Group Title	MitraClip System	Control Group
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
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

Outcome Measure Data

Analysis Population Description

All available data has been reported.

Arm/Group Title	MitraClip System
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
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

Outcome Measure Data

Analysis Population Description

Subjects randomized to the device arm

Arm/Group Title	MitraClip System
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

Analysis Population Description

Total procedure time was available for 293 subjects from the 302 subjects randomized to device arm.

Arm/Group Title	MitraClip System
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
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

Outcome Measure Data

Analysis Population Description

Device time available for all 287 subjects implanted with MitraClip.

Arm/Group Title	MitraClip System
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
Description	Defined as the duration of exposure to fluoroscopy during the MitraClip procedure
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

Fluoroscopy duration for all available subjects with MitraClip device

Arm/Group Title	MitraClip System
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
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

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	3 years

Outcome Measure Data Not Reported

65. Other Pre-specified Outcome

Title	MR Severity Grade
Description	[Not Specified]
Time Frame	4 years

Outcome Measure Data Not Reported

66. Other Pre-specified Outcome

Title	MR Severity Grade
Description	[Not Specified]
Time Frame	5 years

Outcome Measure Data Not Reported

67. Other Pre-specified Outcome

Title	Effective Regurgitant Orifice Area
Description	Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time Frame	Baseline

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
Description	Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time Frame	6 months

Outcome Measure Data

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
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
Description	Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time Frame	12 months

Outcome Measure Data

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
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
Description	Effective Regurgitant Orifice area is defined as = Regurgitant flow / Regurgitant velocity
Time Frame	24 months

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	3 years

Outcome Measure Data Not Reported

73. Other Pre-specified Outcome

Title	Effective Regurgitant Orifice Area
Description	[Not Specified]
Time Frame	4 years

Outcome Measure Data Not Reported

74. Other Pre-specified Outcome

Title	Effective Regurgitant Orifice Area
Description	[Not Specified]
Time Frame	5 years

Outcome Measure Data Not Reported

75. Other Pre-specified Outcome

Title	Regurgitant Volume
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

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	3 years

Outcome Measure Data Not Reported

81. Other Pre-specified Outcome

Title	Regurgitant Volume
Description	[Not Specified]
Time Frame	4 years

Outcome Measure Data Not Reported

82. Other Pre-specified Outcome

Title	Regurgitant Volume
Description	[Not Specified]
Time Frame	5 years

Outcome Measure Data Not Reported

83. Other Pre-specified Outcome

Title	Regurgitant Fraction
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

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
Description	[Not Specified]
Time Frame	3 years

Outcome Measure Data Not Reported

89. Other Pre-specified Outcome

Title	Regurgitant Fraction
Description	[Not Specified]
Time Frame	4 years

Outcome Measure Data Not Reported

90. Other Pre-specified Outcome

Title	Regurgitant Fraction
Description	[Not Specified]
Time Frame	5 years

Outcome Measure Data Not Reported

91. Other Pre-specified Outcome

Title	Left Ventricle End Diastolic Volume (LVEDV)
Description	Left Ventricle End-diastolic volume is the amount of blood that is in the left ventricle before the heart contracts.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available echocardiogram data used for analysis.

Arm/Group Title	MitraClip System	Control Group
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)
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)

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
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)
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

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
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)
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

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
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)
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

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	3 years

Outcome Measure Data Not Reported

97. Other Pre-specified Outcome

Title	Left Ventricle End Diastolic Volume (LVEDV)
Description	[Not Specified]
Time Frame	4 years

Outcome Measure Data Not Reported

98. Other Pre-specified Outcome

Title	Left Ventricle End Diastolic Volume (LVEDV)
Description	[Not Specified]
Time Frame	5 years

Outcome Measure Data Not Reported

99. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Volume (LVESV)
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

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
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)
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)

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
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)
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

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
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)
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

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
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)
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

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	3 years

Outcome Measure Data Not Reported

105. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Volume (LVESV)
Description	[Not Specified]
Time Frame	4 years

Outcome Measure Data Not Reported

106. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Volume (LVESV)
Description	[Not Specified]
Time Frame	5 years

Outcome Measure Data Not Reported

107. Other Pre-specified Outcome

Title	Left Ventricular End Diastolic Dimension (LVEDD)
Description	[Not Specified]
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	At discharge (or 30 days if discharge echocardiogram is not available)

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been presented.

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	3 years

Outcome Measure Data Not Reported

113. Other Pre-specified Outcome

Title	Left Ventricular End Diastolic Dimension (LVEDD)
Description	[Not Specified]
Time Frame	4 years

Outcome Measure Data Not Reported

114. Other Pre-specified Outcome

Title	Left Ventricular End Diastolic Dimension (LVEDD)
Description	[Not Specified]
Time Frame	5 years

Outcome Measure Data Not Reported

115. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Dimension (LVESD)
Description	[Not Specified]
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	At discharge (or 30 days if discharge echocardiogram is not available)

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	3 years

Outcome Measure Data Not Reported

121. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Dimension (LVESD)
Description	[Not Specified]
Time Frame	4 years

Outcome Measure Data Not Reported

122. Other Pre-specified Outcome

Title	Left Ventricular End Systolic Dimension (LVESD)
Description	[Not Specified]
Time Frame	5 years

Outcome Measure Data Not Reported

123. Other Pre-specified Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Description	[Not Specified]
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	At discharge (or 30 days if discharge echocardiogram is not available)

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	3 years

Outcome Measure Data Not Reported

129. Other Pre-specified Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Description	[Not Specified]
Time Frame	4 years

Outcome Measure Data Not Reported

130. Other Pre-specified Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Description	[Not Specified]
Time Frame	5 years

Outcome Measure Data Not Reported

131. Other Pre-specified Outcome

Title	Right Ventricular Systolic Pressure (RVSP)
Description	[Not Specified]
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	At discharge (or 30 days if discharge echocardiogram is not available)

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

All available echocardiogram data has been reported.

Arm/Group Title	MitraClip System	Control Group
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)
Description	[Not Specified]
Time Frame	3 years

Outcome Measure Data Not Reported

137. Other Pre-specified Outcome

Title	Right Ventricular Systolic Pressure (RVSP)
Description	[Not Specified]
Time Frame	4 years

Outcome Measure Data Not Reported

138. Other Pre-specified Outcome

Title	Right Ventricular Systolic Pressure (RVSP)
Description	[Not Specified]
Time Frame	5 years

Outcome Measure Data Not Reported

139. Other Pre-specified Outcome