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Trial record 12 of 12 for:    Atrial Septal Defect 5

EVEREST II Pivotal Study High Risk Registry (HRR) (HRR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01940120
Recruitment Status : Completed
First Posted : September 12, 2013
Results First Posted : January 16, 2017
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Mitral Valve Insufficiency
Mitral Valve Regurgitation
Mitral Valve Incompetence
Mitral Regurgitation
Mitral Insufficiency
Intervention Device: Percutaneous mitral valve repair using MitraClip implant
Enrollment 78
Recruitment Details Patients who met eligibility criteria for the study and had a MitraClip procedure, whether a Device was implanted or not, were considered enrolled in the Registry. A total of 78 patients were enrolled at 35 North American sites. Screening period: Jan, 2007-2008. Enrollment period: Feb 14, 2007- Jan 30, 2008.
Pre-assignment Details  
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Period Title: Overall Study
Started 78
Completed 30
Not Completed 48
Reason Not Completed
Death             40
Withdrawal by Subject             8
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Baseline Participants 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants
76.7  (9.8)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 78 participants
18-75 years 30
>75 years 48
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants
Female
29
  37.2%
Male
49
  62.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 78 participants
United States 77
Canada 1
Predicted Surgical Mortality   [1] 
Mean (Standard Deviation)
Unit of measure:  Probability percentage
Number Analyzed 78 participants
18.2  (8.0)
[1]
Measure Description:

The Society of Thoracic Surgeons' risk models predict the risk of operative mortality & morbidity after adult cardiac surgery.

Risk models were developed for nine specific endpoints, including operative mortality.Operative mortality includes both (1) all deaths occurring during the hospitalization, even if after 30 days (2) deaths occurring after discharge, but within 30 days of the procedure.

Therefore, a patient’s mortality risk score is defined as the patient’s predicted risk of operative mortality as calculated by the specific operative mortality statistical model.

LV Measurement  
Mean (Standard Deviation)
Unit of measure:  mL
Number Analyzed 78 participants
Left Ventricular End Diastolic Volume (LVEDV) 166.5  (50.7)
Left Ventricular End Systolic Volume (LVESV) 79.9  (42.7)
LV Measurement  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 78 participants
Left Ventricular Internal Diameter Diastole(LVIDd) 5.6  (0.7)
Left Ventricular Internal Diameter Systole (LVIDs) 3.9  (1.1)
36-Item Short Form Health Survey (SF-36) Quality of Life   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 78 participants
Physical Health (PCS) 31.6  (9.1)
Mental Health (MCS) 44.2  (12.6)
[1]
Measure Description: The SF-36 is a multidimensional, patient-reported survey containing 36 questions on a 0-100 scale measuring physical (Physical Component Score PCS) & mental health status (Mental Component Score MCS) in relation to 8 health concepts: physical functioning, role limitations due to physical or emotional health, bodily pain, general health perceptions, vitality, social functioning, & general mental health. Higher scores represent better self-perceived health. The PCS & MCS norms for 65-75 year olds are 44 and 52, while the norms for CHF population are 31 and 46, respectively.
NYHA Functional Class   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 78 participants
NYHA Functional Class I 0
NYHA Functional Class II 8
NYHA Functional Class III 47
NYHA Functional Class IV 23
[1]
Measure Description:

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

Class II: Patients with cardiac disease resulting in slight limitation of physical activity. Patients are comfortable at rest.

Class III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.

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

Number of patients hospitalized for CHF during 12 months before enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 78 participants
Number of patients hospitalized for CHF 33
Number of patients not hospitalized for CHF 45
Number of CHF events leading to hospitalizations during 12 months before enrollment  
Measure Type: Number
Unit of measure:  Events
Number Analyzed 78 participants
51
Number of hospitalization days for CHF at 12 months before enrollment  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 78 participants
6.0  (4.6)
1.Primary Outcome
Title Composite Functional and Structural Measures - Freedom From Death
Hide Description

Defined as all causes of death for the primary safety Major Adverse Event (MAE) Endpoint. Death is further divided into 2 categories:

A. Cardiac death is defined as death due to any of the following:

  1. Acute myocardial infarction.
  2. Cardiac perforation/pericardial tamponade.
  3. Arrhythmia or conduction abnormality.
  4. Stroke within 30 days of the procedure or stroke suspected of being related to the procedure.
  5. Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.
  6. Any death for which a cardiac cause cannot be excluded.

B. Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
59
  75.6%
2.Primary Outcome
Title Percentage of Participants With Freedom From Death and Mitral Regurgitation (MR) >2+
Hide Description Kaplan-Meier estimated percentage of patients who are alive and have a mitral regurgitation severity grade of 2+ or less
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: percentage of participants
Primary Analysis 56.4
Worst case Analysis 53.8
3.Primary Outcome
Title Number of Participants With Clinical Measures of Benefit-New York Heart Association (NYHA) Class
Hide Description

The major effectiveness endpoint is an assessment of multiple functional and structural measures of benefit including New York Heart Association (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. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation dyspnea, or anginal pain.

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

Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
71 out of 78 patients (at baseline) were analyzed at 30 days. There were 6 deaths prior to 30 days. So, NYHA at 30 days is missing due to death in 6 patients, and missing due to other reasons in 1 patient.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 71
Measure Type: Count of Participants
Unit of Measure: Participants
NYHA Functional Class I
14
  19.7%
NYHA Functional Class II
38
  53.5%
NYHA Functional Class III
16
  22.5%
NYHA Functional Class IV
3
   4.2%
4.Primary Outcome
Title Number of Participants With New York Heart Association (NYHA) Class
Hide Description

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

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

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

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

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and 2 patients without NYHA Class assessment.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 54
Measure Type: Count of Participants
Unit of Measure: Participants
NYHA Functional Class I
18
  33.3%
NYHA Functional Class II
22
  40.7%
NYHA Functional Class III
13
  24.1%
NYHA Functional Class IV
1
   1.9%
5.Primary Outcome
Title Clinical Measures of Benefit-Quality of Life (QOL) as Measured by Short Form (SF) 36
Hide Description Standardized quality of life surveys allow physicians to evaluate the effectiveness of different treatment methods and the physical and psychological benefits a patient is likely to receive from a particular treatment.In the EVEREST II HRR,the patients were asked to complete the SF-36 QOL survey at baseline, 30 days and 12 months. The physical & mental function were assessed by the Physical Component Summary (PCS) score & Mental Component Summary (MCS) score. The PCS & MCS norms for 65-75 year olds are 44 and 52 respectively; and 31 & 46 for congestive heart failure (CHF) patients respectively. Each scale from the SF-36 is an algebraic sum of responses for all items in that scale.For ease of analysis each scale is then transformed to a 0-100 scale using a formula that converts the lowest & highest possible scores to 0 & 100 respectively.The scoring of the SF-36 indicates that 0% in a domain represents the poorest possible QoL & 100% indicates full QoL.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
PCS 36.1  (10.8)
MCS 48.7  (11.9)
6.Primary Outcome
Title Left Ventricular End Diastolic Volume (LVEDV)
Hide Description Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LVEDV was not done or un-evaluable in 2 patients.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: ml
139.7  (42.6)
7.Primary Outcome
Title Left Ventricular End Systolic Volume (LVESV)
Hide Description Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LVESV was not done or un-evaluable in 2 patients.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: ml
72.2  (35.8)
8.Primary Outcome
Title Left Ventricular (LV) Function - Internal Dimension
Hide Description Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and LIVDs/LVIDs evaluation was not done or un-evaluable in 2 patients.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: cm
LV Internal Dimension diastole (LVIDd) 5.3  (0.7)
LV Internal Dimension systole (LVIDs) 3.8  (1.0)
9.Primary Outcome
Title Number of Patients With CHF Having Hospitalization During Discharge Through 12 Months
Hide Description Number of patients with incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Three patients died before discharge and thus do not provide data on post-discharge hospitalizations.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 75
Measure Type: Count of Participants
Unit of Measure: Participants
12
  16.0%
10.Primary Outcome
Title Number of CHF Events Leading to Hospitalizations During Discharge Through 12 Months
Hide Description Incidence of re-hospitalizations for CHF in the 12-months after the MitraClip implant procedure.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Three patients died before discharge and thus do not provide data on post-discharge hospitalizations.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 75
Measure Type: Count of Participants
Unit of Measure: Participants
22
  29.3%
11.Primary Outcome
Title Left Ventricular End Diastolic Volume (LVEDV)
Hide Description Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame Discharge or 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 75
Mean (Standard Deviation)
Unit of Measure: ml
147.9  (48.8)
12.Primary Outcome
Title Left Ventricular End Systolic Volume (LVESV)
Hide Description Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame Discharge or 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 75
Mean (Standard Deviation)
Unit of Measure: ml
74.3  (40.4)
13.Primary Outcome
Title Left Ventricular (LV) Function - Internal Dimension
Hide Description Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame Discharge or 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 76
Mean (Standard Deviation)
Unit of Measure: cm
LV Internal Dimension diastole (LVIDd) 5.4  (0.8)
LV Internal Dimension systole (LVIDs) 3.9  (1.0)
14.Secondary Outcome
Title Number of Participants Experiencing Major Adverse Events (MAE)
Hide Description Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
21
  26.9%
15.Secondary Outcome
Title Number of Participants Experiencing Major Adverse Events
Hide Description Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
33
  42.3%
16.Secondary Outcome
Title Procedural Freedom From In-hospital MAE
Hide Description Percutaneous Clip procedure or surgery with no occurrence of in-hospital MAE.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: participants
61
17.Secondary Outcome
Title Number of Participants Over 75 Years of Age With MAE
Hide Description Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes 48 patients who were aged 75 years or older in the study.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 48
Measure Type: Count of Participants
Unit of Measure: Participants
14
  29.2%
18.Secondary Outcome
Title Number of Participants Over 75 Years of Age With MAE
Hide Description Combined clinical endpoint of death, myocardial infarction, reoperation for failed surgical repair or replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for greater than 48 hours, GI complication requiring surgery, new onset of permanent atrial fibrillation, septicemia, and transfusion of 2 or more units of blood.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes 48 patients who were aged 75 years or older in the study.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 48
Measure Type: Count of Participants
Unit of Measure: Participants
23
  47.9%
19.Secondary Outcome
Title Number of Participants Experiencing Major Vascular Complications
Hide Description

Defined as the occurrence of any of the following resulting from the index procedure:

  • Hematoma at access site >6 cm;
  • Retroperitoneal hematoma;
  • Arterial-venous fistula;
  • Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours;
  • Vascular surgical repair at catheter access sites;
  • Pulmonary embolism;
  • Ipsilateral deep vein thrombus; or
  • Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
2
   2.6%
20.Secondary Outcome
Title Number of Participants Experiencing Major Vascular Complications
Hide Description

Defined as the occurrence of any of the following resulting from the index procedure:

  • Hematoma at access site >6 cm;
  • Retroperitoneal hematoma;
  • Arterial-venous fistula;
  • Symptomatic peripheral ischemia/ nerve injury with clinical signs or symptoms lasting >24 hours;
  • Vascular surgical repair at catheter access sites;
  • Pulmonary embolism;
  • Ipsilateral deep vein thrombus; or
  • Access site-related infection requiring intravenous antibiotics and/or extended hospitalization.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
3
   3.8%
21.Secondary Outcome
Title Number of Participants With Major Bleeding Complications
Hide Description Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
13
  16.7%
22.Secondary Outcome
Title Number of Participants With Major Bleeding Complications
Hide Description Defined as procedure related bleeding that requires a transfusion of ≥2 units of blood and/or surgical intervention.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
15
  19.2%
23.Secondary Outcome
Title Number of Participants With Non-cerebral Thromboembolism
Hide Description Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
24.Secondary Outcome
Title Number of Participants With Non-cerebral Thromboembolism
Hide Description Defined as any mural thrombus or thromboembolism in the vasculature (excluding central nervous system events) confirmed by standard clinical and laboratory testing and which requires intervention.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.3%
25.Secondary Outcome
Title Number of Participants With Thrombosis
Hide Description Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
26.Secondary Outcome
Title Number of Participants With Thrombosis
Hide Description Evidence of formation of an independently moving thrombus on any part of the Clip or any commercially available implant used during surgery by echocardiography or fluoroscopy. If Clip is explanted or an autopsy is performed this diagnosis should be confirmed.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
27.Secondary Outcome
Title Number of Participants With Hemolysis
Hide Description Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
28.Secondary Outcome
Title Number of Participants With Hemolysis
Hide Description Defined as new onset of anemia associated with laboratory evidence of red cell destruction. Diagnosed when plasma free hemoglobin is greater than 40 mg/dL on two measures within 24 hours or on one measure if intervention is initiated based on other clinical symptoms.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
29.Secondary Outcome
Title Number of Participants With Dysrhythmias
Hide Description Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
5
   6.4%
30.Secondary Outcome
Title Number of Participants With Dysrhythmias
Hide Description Includes all new onset atrial fibrillation and heart block requiring placement of a permanent pacemaker.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
8
  10.3%
31.Secondary Outcome
Title Number of Participants With Endocarditis
Hide Description

Using Duke Criteria, endocarditis can be confirmed by:

Pathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed & histologically confirmed showing active endocarditis.

Clinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria. Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation. Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, & positive blood culture or echocardiogram not meeting major criteria.

Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
32.Secondary Outcome
Title Number of Participants With Endocarditis
Hide Description

Using Duke Criteria, endocarditis can be confirmed by:

Pathological criteria: Endocarditis is confirmed if microorganisms are identified by culture or histology in a vegetation, embolized vegetation, or an intracardiac abscess; or if pathological lesions are observed & histologically confirmed showing active endocarditis.

Clinical criteria: Endocarditis is confirmed by the presence of 2 major criteria, 1 major plus 3 minor criteria, or 5 minor criteria.

Major criteria include persistently +ve blood cultures with the presence of typical organisms for endocarditis; persistent bacteremia; evidence of endocardial involvement with positive echocardiogram with signs of oscillating vegetation, abscesses, valve perforation, new partial dehiscence of prosthetic valve or new valvular regurgitation.

Minor criteria include predisposing heart condition, fever, vascular phenomena, immunologic phenomena, & positive blood culture or echocardiogram not meeting major criteria.

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.3%
33.Secondary Outcome
Title Number of Participants With Atrial Septal Defect (ASD)
Hide Description Occurrence of clinically significant ASD as a result of the procedure requiring intervention.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:

Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.

.

Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
2
   2.6%
34.Secondary Outcome
Title Number of Participants With Atrial Septal Defect (ASD)
Hide Description Occurrence of clinically significant ASD as a result of the procedure requiring intervention.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
2
   2.6%
35.Secondary Outcome
Title Number of Participants With Mitral Valve Stenosis
Hide Description Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Of total 78 participants, only 72 participants were analyzed as 6 deaths within 30 days.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 72
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
36.Secondary Outcome
Title Number of Participants With Mitral Valve Stenosis
Hide Description Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of total 78 participants, only 72 participants were analyzed because 3 patients were not implanted with a device and 3 patients died prior to discharge.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 72
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
37.Secondary Outcome
Title Number of Participants With Mitral Valve Stenosis
Hide Description Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
2
   2.6%
38.Secondary Outcome
Title Number of Participants With Mitral Valve Stenosis
Hide Description Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
2
   2.6%
39.Secondary Outcome
Title Number of Participants With Mitral Valve Stenosis
Hide Description Mitral stenosis associated with a total mitral valve orifice area less than 1.5 cm2.
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
2
   2.6%
40.Secondary Outcome
Title Mitral Valve Area: By Planimetry
Hide Description Mitral valve area as measured by core lab echocardiography.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 50 participants were included in analysis population because of 6 deaths and Mitral Valve Area by planimetry was not done in 22 patients.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: cm^2
3.3  (0.9)
41.Secondary Outcome
Title Mitral Valve Area: By Planimetry
Hide Description Mitral valve area as measured by core lab echocardiography.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 45 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 11 patients Mitral valve area evaluation was not done or un-evaluable.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: cm^2
3.0  (1.0)
42.Secondary Outcome
Title Mitral Valve Area: By Planimetry
Hide Description Mitral valve area as measured by core lab echocardiography.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 19 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 25 patients Mitral valve area evaluation was not done or un-evaluable.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: cm^2
3.3  (0.6)
43.Secondary Outcome
Title Mitral Valve Area: By Planimetry
Hide Description Mitral valve area as measured by core lab echocardiography.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 25 participants were included in analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and in 14 patients mitral valve area evaluation was not done or un-evaluable.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: cm^2
2.9  (0.8)
44.Secondary Outcome
Title Mitral Valve Area: By Planimetry
Hide Description Mitral valve area as measured by core lab echocardiography.
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 18 participants were included in analysis population because of 33 deaths within 4 years, 8 withdrawals, 3 missed visit and in 16 patients Mitral Valve Area evaluation was not done or un-evaluable.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: cm^2
3.0  (0.7)
45.Secondary Outcome
Title Mitral Valve Area: By Planimetry
Hide Description Mitral valve area as measured by core lab echocardiography.
Time Frame 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: cm^2
2.9  (0.8)
46.Secondary Outcome
Title Mitral Valve Area: By Pressure Half-time
Hide Description Mitral valve area as measured by core lab echocardiography.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 66 participants were included in analysis population because of 6 deaths and in 6 patients Mitral valve area evaluation was not done or un-evaluable.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 66
Mean (Standard Deviation)
Unit of Measure: cm^2
2.9  (1.2)
47.Secondary Outcome
Title Mitral Valve Area: By Pressure Half-time
Hide Description Mitral valve area as measured by core lab echocardiography.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Mitral valve area evaluation was not done or un-evaluable.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 53
Mean (Standard Deviation)
Unit of Measure: cm^2
3.0  (1.2)
48.Secondary Outcome
Title Mitral Valve Area: By Pressure Half-time
Hide Description Mitral valve area as measured by core lab echocardiography.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Mitral valve area evaluation was not done or un-evaluable.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: cm^2
2.8  (0.8)
49.Secondary Outcome
Title Mitral Valve Area: By Pressure Half-time
Hide Description Mitral valve area as measured by core lab echocardiography.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: cm^2
2.9  (0.8)
50.Secondary Outcome
Title Mitral Valve Area: By Pressure Half-time
Hide Description Mitral valve area as measured by core lab echocardiography.
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: cm^2
2.8  (0.9)
51.Secondary Outcome
Title Mitral Valve Area: By Pressure Half-time
Hide Description Mitral valve area as measured by core lab echocardiography.
Time Frame 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: cm^2
2.8  (0.7)
52.Secondary Outcome
Title Mitral Valve Area Index : By Planimetry
Hide Description Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 50 participants were included in analysis population because of 6 deaths and Mitral Valve Area Index by planimetry was not done in 22 patients.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: cm^2/m^2
1.7  (0.5)
53.Secondary Outcome
Title Mitral Valve Area Index : By Planimetry
Hide Description Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 45 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 11 patients Mitral Valve Area evaluation was not done or un-evaluable.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: cm^2/m^2
1.6  (0.5)
54.Secondary Outcome
Title Mitral Valve Area Index : By Planimetry
Hide Description Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 19 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 25 patients Mitral Valve Area evaluation was not done or un-evaluable
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: cm^2/m^2
1.7  (0.3)
55.Secondary Outcome
Title Mitral Valve Area Index : By Planimetry
Hide Description Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: cm^2/m^2
1.5  (0.4)
56.Secondary Outcome
Title Mitral Valve Area Index : By Planimetry
Hide Description Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: cm^2/m^2
1.5  (0.4)
57.Secondary Outcome
Title Mitral Valve Area Index : By Planimetry
Hide Description Mitral valve area as measured by core lab echocardiography by planimetry and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: cm^2/m^2
1.5  (0.4)
58.Secondary Outcome
Title Mitral Valve Area (MVA) Index: by Pressure-Half Time Formula
Hide Description

Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to Body surface area (BSA).

[MVA Index = MVA (cm^2)/BSA (m^2)]

Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 65 participants were included in analysis population because of 6 deaths and Mitral Valve Area Index by pressure half-time was not done in 7 patients.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 65
Mean (Standard Deviation)
Unit of Measure: cm^2/m^2
1.6  (0.7)
59.Secondary Outcome
Title Mitral Valve Area Index : By Pressure Half-time Formula
Hide Description Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Mitral Valve Area evaluation was not done or un-evaluable
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 53
Mean (Standard Deviation)
Unit of Measure: cm^2/m^2
1.6  (0.7)
60.Secondary Outcome
Title Mitral Valve Area Index : By Pressure Half-time Formula
Hide Description Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 40 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Mitral Valve Area evaluation was not done or un-evaluable
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: cm^2/m^2
1.5  (0.5)
61.Secondary Outcome
Title Mitral Valve Area Index : By Pressure Half-time Formula
Hide Description Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: cm^2/m^2
1.5  (0.5)
62.Secondary Outcome
Title Mitral Valve Area Index : By Pressure Half-time Formula
Hide Description Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: cm^2/m^2
1.5  (0.5)
63.Secondary Outcome
Title Mitral Valve Area Index : By Pressure Half-time Formula
Hide Description Mitral valve area as measured by core lab echocardiography using the pressure half-time formula and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)].
Time Frame 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: cm^2/m^2
1.5  (0.4)
64.Secondary Outcome
Title Transvalvular Mitral Valve Gradient
Hide Description Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 69 participants were included in the analysis population because of 6 deaths within 30 days and in 3 participants Mitral Valve Gradient was not done or un-evaluable.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 69
Mean (Standard Deviation)
Unit of Measure: mmHg
3.9  (2.6)
65.Secondary Outcome
Title Transvalvular Mitral Valve Gradient
Hide Description Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 53 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 3 patients Mitral Valve Gradient evaluation was not done or un-evaluable.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 53
Mean (Standard Deviation)
Unit of Measure: mmHg
3.6  (2.9)
66.Secondary Outcome
Title Transvalvular Mitral Valve Gradient
Hide Description Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 40 participants were included in analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and in 4 patients Mitral Valve Gradient evaluation was not done or un-evaluable.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: mmHg
3.2  (1.9)
67.Secondary Outcome
Title Transvalvular Mitral Valve Gradient
Hide Description Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 36 participants were included in analysis population because of 31 deaths within 2 years, 7 withdrawals, 1 missed visit and in 3 patients Mitral Valve Gradient evaluation was not done or un-evaluable.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 36
Mean (Standard Deviation)
Unit of Measure: mmHg
3.8  (2.7)
68.Secondary Outcome
Title Transvalvular Mitral Valve Gradient
Hide Description Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 31 participants were included in analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and in 8 patients Mitral Valve Gradient evaluation was not done or un-evaluable.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: mmHg
3.6  (1.8)
69.Secondary Outcome
Title Transvalvular Mitral Valve Gradient
Hide Description Defined as the mean pressure gradients across the mitral valve as measured by echocardiography.
Time Frame 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: mmHg
3.8  (2)
70.Secondary Outcome
Title Mitral Valve Index
Hide Description Mitral valve area as measured by core lab echocardiography and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 50 participants were included in the analysis population because of 6 deaths within 30 days and in 22 participants Mitral valve index was not done or un-evaluable.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: cm^2/m^2
1.7  (0.5)
71.Secondary Outcome
Title Mitral Valve Index
Hide Description Mitral valve area as measured by core lab echocardiography and indexed to body surface area [MVA Index = MVA (cm^2)/BSA (m^2)]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 45 participants were included in analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and in 11 patients Mitral valve index evaluation was not done or un-evaluable.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: cm^2/m^2
1.6  (0.5)
72.Secondary Outcome
Title Number of Participants With New Coumadin Use
Hide Description New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
49 patients not on coumadin at baseline are included in the analysis.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 49
Measure Type: Count of Participants
Unit of Measure: Participants
9
  18.4%
73.Secondary Outcome
Title Number of Participants With New Coumadin Use
Hide Description New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
49 patients not on coumadin at baseline are included in the analysis.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 49
Measure Type: Count of Participants
Unit of Measure: Participants
11
  22.4%
74.Secondary Outcome
Title Number of Participants With New Coumadin Use
Hide Description New onset use of Coumadin or warfarin to treat a potential thrombus on a defibrillator lead.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
49 patients not on coumadin at baseline are included in the analysis.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 49
Measure Type: Count of Participants
Unit of Measure: Participants
12
  24.5%
75.Secondary Outcome
Title Number of Participants Discharged to a Nursing Home or Skilled Nursing Facility or Hospital
Hide Description Discharge to a nursing home or skilled nursing facility following discharge from the hospital after definitive treatment.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
6
   7.7%
76.Secondary Outcome
Title Post-procedure Length of Hospital Stay
Hide Description Defined as the number of days from the end of the procedure until the patient is discharged from the hospital. This does not include time in a nursing or skilled care facility.
Time Frame Length of Hospital Stay, assessed at 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Mean (Standard Deviation)
Unit of Measure: days
3.9  (6.4)
77.Secondary Outcome
Title Post-procedure Intensive Care Unit (ICU)/ Critical Care Unit (CCU) Time
Hide Description Number of hours patients are in an intensive care unit or step down unit before discharge or moving to a standard care unit.
Time Frame Length of ICU/CCU stay, assessed at 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Mean (Standard Deviation)
Unit of Measure: hours
52.3  (80.6)
78.Secondary Outcome
Title Number of Participants With Successful Clip Implant
Hide Description Rate of successful delivery and deployment of Clip implants with echocardiographic evidence of leaflet approximation and retrieval of the investigational delivery catheter.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
74
  94.9%
79.Secondary Outcome
Title Number of Participants With High Risk Procedural Success
Hide Description Successful implantation of the Clip (s) with resulting MR severity of 2+ of less at discharge or a 1 grade MR reduction at discharge accompanied by a 1 level reduction in NYHA.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
60
  76.9%
80.Secondary Outcome
Title Number of Participants With MR Severity
Hide Description MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
Time Frame Discharge or 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 76
Measure Type: Count of Participants
Unit of Measure: Participants
0 : None
0
   0.0%
1+: Mild
30
  39.5%
2+: Moderate
26
  34.2%
3+: Moderate to Severe
14
  18.4%
4+: Severe
6
   7.9%
81.Secondary Outcome
Title Number of Participants With MR Severity
Hide Description MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 54 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals, 1 missed visit and MR Severity not done or un-evaluable in 2 patients.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 54
Measure Type: Count of Participants
Unit of Measure: Participants
0+: None
0
   0.0%
1+: Mild
17
  31.5%
2+: Moderate
25
  46.3%
3+: Moderate to Severe
9
  16.7%
4+: Severe
3
   5.6%
82.Secondary Outcome
Title Number of Participants With MR Severity
Hide Description MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 42 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and MR severity not assessed in 2 patients.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 42
Measure Type: Count of Participants
Unit of Measure: Participants
0+: None
0
   0.0%
1+: Mild
14
  33.3%
2+: Moderate
23
  54.8%
3+: Moderate to Severe
5
  11.9%
4+: Severe
0
   0.0%
83.Secondary Outcome
Title Number of Participants With MR Severity
Hide Description MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 37 participants were included in the analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and MR Severity was not done or un-evaluable in 2 patients.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 37
Measure Type: Count of Participants
Unit of Measure: Participants
0+: None
0
   0.0%
1+: Mild
16
  43.2%
2+: Moderate
16
  43.2%
3+: Moderate to Severe
5
  13.5%
4+: Severe
0
   0.0%
84.Secondary Outcome
Title Number of Participants With MR Severity
Hide Description MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 31 participants were included in the analysis population because of 33 deaths within 3 years, 8 withdrawals, 3 missed visit and MR severity was not done or un-evaluable in 3 patients.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
0+: None
0
   0.0%
1+: Mild
18
  58.1%
2+: Moderate
9
  29.0%
3+: Moderate to Severe
3
   9.7%
4+: Severe
1
   3.2%
85.Secondary Outcome
Title Number of Participants With MR Severity
Hide Description MR Severity: Site-assessed mitral regurgitation severity using echocardiography. MR severity is graded on a scale of 0+ to 4+ where 0+ means absence of mitral regurgitation, 1+ is mild, 1+ to 2+ is mild-to-moderate, 2+ to 3+ is moderate to moderate-to-Severe, 3+ is moderate-to-severe, 3+ to 4+ is moderate-to-severe to severe, 4+ is severe.
Time Frame 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
0+: None
0
   0.0%
1+: Mild
12
  50.0%
2+: Moderate
6
  25.0%
3+: Moderate to Severe
6
  25.0%
4+: Severe
0
   0.0%
86.Secondary Outcome
Title Number of Participants With Treatment Durability
Hide Description Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 56 participants were included in the analysis population because of 18 deaths within 1 year, 3 withdrawals and 1 missed visit.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 56
Measure Type: Count of Participants
Unit of Measure: Participants
39
  69.6%
87.Secondary Outcome
Title Number of Participants With Treatment Durability
Hide Description Defined as the proportion of Acute Procedural Success patients with MR severity grade of 2+ or less that have not required surgery for valve dysfunction.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
At 24 months, of the 56 patients who achieved acute procedural success, the status of 3 patients is unknown. Among the remaining 53 patients, 30 patients (56.6%) were alive and free from MR > 2+ at 24 months.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 53
Measure Type: Count of Participants
Unit of Measure: Participants
30
  56.6%
88.Secondary Outcome
Title Number of Participants With Clinical Durability
Hide Description Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 62 patients with an acute reduction in MR severity of at least one grade, and of these, 43 patients met the criterion for clinical durability. The clinical durability rate is therefore 43/62, or 69.4%.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 62
Measure Type: Count of Participants
Unit of Measure: Participants
43
  69.4%
89.Secondary Outcome
Title Number of Participants With Clinical Durability
Hide Description Proportion of patients who have an acute reduction in MR severity of at least one grade (as measured by the discharge echocardiogram) that have not required surgery for valve dysfunction and meet either of the following: 1) MR severity grade of 2+ or less or 2) a one grade reduction in MR severity compared to baseline accompanied by at least a one level reduction in NYHA.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Through 24 months, the clinical durability status of 3 patients is unknown and there were 35 patients with an acute reduction in MR severity from baseline of at least one grade (the one patient who underwent surgery between 12 months and 24 months is not included in the 35 patients).
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 59
Measure Type: Count of Participants
Unit of Measure: Participants
35
  59.3%
90.Secondary Outcome
Title Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class
Hide Description

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

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

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

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

Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 43 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and 1 patient without NYHA Class assessment.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 43
Measure Type: Count of Participants
Unit of Measure: Participants
NYHA Functional Class I
13
  30.2%
NYHA Functional Class II
24
  55.8%
NYHA Functional Class III
5
  11.6%
NYHA Functional Class IV
1
   2.3%
91.Secondary Outcome
Title Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class
Hide Description

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

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

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

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

Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 37 participants were included in analysis population because of 31 deaths within 3 years, 7 withdrawals, 1 missed visit and 2 patients without NYHA Class assessment.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 37
Measure Type: Count of Participants
Unit of Measure: Participants
NYHA Functional Class I
10
  27.0%
NYHA Functional Class II
20
  54.1%
NYHA Functional Class III
7
  18.9%
NYHA Functional Class IV
0
   0.0%
92.Secondary Outcome
Title Number of Participants With Composite Functional and Structural Measures - Clinical Measures of Benefit-New York Heart Association (NYHA) Class
Hide Description

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

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

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

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

Time Frame 48 months
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Of 78 total population, 31 participants were included in the analysis population because of 33 deaths within 3 years, 8 withdrawals, 3 missed visit and NYHA was not assessed in 3 patients.
Arm/Group Title High Risk Registry Arm
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Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
NYHA Functional Class I
8
  25.8%
NYHA Functional Class II
20
  64.5%
NYHA Functional Class III
3
   9.7%
NYHA Functional Class IV
0
   0.0%
93.Secondary Outcome
Title Number of Participants With New York Heart Association (NYHA) Class
Hide Description

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

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

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

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

Time Frame 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
NYHA Functional Class I
6
  25.0%
NYHA Functional Class II
14
  58.3%
NYHA Functional Class III
4
  16.7%
NYHA Functional Class IV
0
   0.0%
94.Secondary Outcome
Title Left Ventricular End-diastolic Volume (LVEDV).
Hide Description Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 39 participants were included in the analysis population because of 26 deaths within 2 year, 7 withdrawals, 1 missed visit and LVEDV was not done or un-evaluable in 5 patients.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: mL
136.3  (37.8)
95.Secondary Outcome
Title Left Ventricular End-diastolic Volume (LVEDV).
Hide Description Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 36
Mean (Standard Deviation)
Unit of Measure: mL
135.7  (40.3)
96.Secondary Outcome
Title Left Ventricular End-diastolic Volume (LVEDV).
Hide Description Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: mL
139.5  (46.6)
97.Secondary Outcome
Title Left Ventricular End-diastolic Volume (LVEDV).
Hide Description Left Ventricular End Diastolic Volume (LVEDV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: mL
133.5  (48.9)
98.Secondary Outcome
Title Left Ventricular End-systolic Volume (LVESV).
Hide Description Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 39 participants were included in the analysis population because of 26 deaths within 2 year, 7 withdrawals, 1 missed visit and LVESV was not done or un-evaluable in 5 patients.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: mL
71.3  (33.4)
99.Secondary Outcome
Title Left Ventricular End-systolic Volume (LVESV).
Hide Description Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 36
Mean (Standard Deviation)
Unit of Measure: mL
66.4  (33.1)
100.Secondary Outcome
Title Left Ventricular End-systolic Volume (LVESV).
Hide Description Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: mL
73.3  (36.9)
101.Secondary Outcome
Title Left Ventricular End-systolic Volume (LVESV).
Hide Description Left Ventricular End Systolic Volume (LVESV) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: mL
67.2  (38)
102.Secondary Outcome
Title Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)
Hide Description Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Of 78 total population, 42 participants were included in the analysis population because of 26 deaths within 2 years, 7 withdrawals, 1 missed visit and LVIDd/LVIDs not done or un-evaluable in 2 patients.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 42
Mean (Standard Deviation)
Unit of Measure: cm
LV Internal Diameter, Diastole (LVIDd) 5.3  (0.8)
LV Internal Diameter, Systole (LVIDs) 4.0  (1.0)
103.Secondary Outcome
Title Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)
Hide Description Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 37
Mean (Standard Deviation)
Unit of Measure: cm
LV Internal Diameter, Diastole (LVIDd) 5.4  (0.8)
LV Internal Diameter, Systole (LVIDs) 4.1  (1.1)
104.Secondary Outcome
Title Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)
Hide Description Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: cm
LV Internal Diameter, Diastole (LVIDd) 5.5  (0.7)
LV Internal Diameter, Systole (LVIDs) 4.0  (1.0)
105.Secondary Outcome
Title Left Ventricular Measurement: Left Ventricular Internal Dimension Diastole (LVIDd), Left Ventricular Internal Dimension Systole (LVIDs)
Hide Description Left Ventricular Internal Dimension in diastole (LVIDd) and Left Ventricular Internal Dimension in systole (LVIDs) as determined by the core echocardiography laboratory from a transthoracic echocardiogram (TTE).
Time Frame 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed includes subjects who had available follow up data at that time frame.
Arm/Group Title High Risk Registry Arm
Hide Arm/Group Description:
Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: cm
LV Internal Diameter, Diastole (LVIDd) 5.5  (0.8)
LV Internal Diameter, Systole (LVIDs) 4.2  (1.0)
106.Secondary Outcome
Title Number of Days Re-hospitalized for CHF