MitraClip System in Australia and New Zealand (MitraClipANZ)

A Prospective Single Arm Clinical Trial Evaluating the MitraClip System in Australia and New Zealand

The primary objective of the MitraClip System Australia and New Zealand (ANZ) Clinical Trial is to gather real-world clinical and health-economic outcome data to support the long-term safety, efficacy and economic value of the MitraClip System in the continuum of therapies for treating MR. Specifically, the following clinical and economic data will be collected: New York Heart Association (NYHA) Functional Class, Six-Minute Walk Test (6MWT) distance, quality of life (QOL) information, echocardiographic measures of left ventricular size and function, and data associated with the index hospitalization, rehospitalizations, concomitant medications and discharge facility to support the MitraClip System economic analysis.

Study Overview

• Status: Terminated
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Device: MitraClip Implant

Detailed Description

The MitraClip System ANZ Clinical Trial is a prospective, observational, single arm, multicenter trial to evaluate the MitraClip device for the treatment of mitral regurgitation (MR). Patients will be enrolled at up to 15 investigational sites throughout Australia and New Zealand. Up to 150 patients will be enrolled. Patients will be considered enrolled when local or general anesthesia is administered for the MitraClip procedure. Patients will be followed at discharge, 30 days, 6 months, 12 months and 24 months.

Investigational sites will recruit consecutive patients who meet trial enrollment criteria. Until enrollment in the MitraClip System ANZ Clinical Trial is closed, all patients who undergo a procedure for placement of a MitraClip device at an investigational site should be enrolled in the MitraClip System ANZ Clinical Trial.

• Study Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • St. Vincent's Hospital Sydney
    • North Ryde, New South Wales, Australia, 2109
      • Macquarie University Hosptial
    • St Leonards, New South Wales, Australia, 2065
      • North Shore Private Hospital
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • The Prince Charles Hospital
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients eligible to receive the MitraClip implant at the designated investigational sites in Australia and New Zealand.

Description

Inclusion Criteria:

• Age 18 years or older.
• MR ≥ 3+ .
• Transseptal catheterization and femoral vein access feasible.
• Placement of the MitraClip device on mitral leaflets feasible.
• Mitral valve orifice area ≥ 4.0 cm2.
• Written informed consent obtained.
• The patient agrees to return for follow-up visits.

Exclusion Criteria:

• Need for emergency surgery, other cardiac surgery.
• Coronary artery disease (CAD), atrial fibrillation (AF), other valve disease.
• Prior mitral valve repair surgery, mechanical prosthetic valve, or ventricular assist device (VAD).
• Active endocarditis or rheumatic heart disease; leaflets degenerated from endocarditis or rheumatic disease.
• Transesophageal echocardiography (TEE) contraindicated.
• Known hypersensitivity or contraindication to trial or procedure medications which cannot be managed medically.
• Currently participating in investigational drug trial or another device trial that has not yet completed the primary endpoint or that interferes with the MitraClip System ANZ Clinical Trial.
• Pregnant or planning pregnancy within next 12 months.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MitraClip Implant; Eligible patients undergoing a MitraClip procedure in Australia and New Zealand	Device: MitraClip Implant; Percutaneous mitral valve repair using MitraClip implant.; Other Names: MitraClip System; MitraClip Delivery System; Steerable Guide Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)	Clinical Endpoint.; Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.); Non-cardiac death is defined as a death not due to cardiac causes (as defined above).	Baseline
Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)	Clinical Endpoint.; Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.); Non-cardiac death is defined as a death not due to cardiac causes (as defined above).	30 days
Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)	Clinical Endpoint.; Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.); Non-cardiac death is defined as a death not due to cardiac causes (as defined above).	6 months
Percentage of Participants Experiencing Death (Kaplan-Meier Analysis)	Clinical Endpoint.; Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.); Non-cardiac death is defined as a death not due to cardiac causes (as defined above).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With 0, 1, 2, and 3 MitraClip Devices Implanted	This is one of the Device and Procedure-Related Endpoints. Implant Rate is defined as the rate of successful delivery and deployment of MitraClip device implant(s) with echocardiographic evidence of leaflet approximation and retrieval of the delivery catheter.	Day 0 (On the day of procedure)
Number of Participants With Acute Procedural Success Rate	Defined as successful MitraClip implantation with resulting MR of 2+ or less.	At day 0 (on the day of index procedure)
Procedure Time	This is one of the Device and Procedure-Related Endpoints. Procedure Time is defined as the time elapsed from the start of the transseptal procedure to the time the Steerable Guide Catheter is removed.	At day 0 (on the day of index procedure)
Device Time	This is one of the Device and Procedure-Related Endpoints. Device Time is defined as the time the Steerable Guide Catheter is placed in the intra-atrial septum until the time the MitraClip Delivery System (CDS) is retracted into the Steerable Guide Catheter. Device Time is shorter in duration than Procedure Time because it does not include the time required to perform transseptal access into the left atrium.	At day 0 (on the day of index procedure)
Fluoroscopy Duration	This is one of the Device and Procedure-Related Endpoints. Mean fluoroscopy duration during the MitraClip procedure.	At day 0 (on the day of index procedure)
Total Contrast Volume	This is one of the Device and Procedure-Related Endpoints.	At day 0 (on the day of index procedure)
Left Ventricle End Diastolic Volume (LVEDV)	Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.	At Baseline and Discharge (≤7 days of index procedure)
Left Ventricle End Diastolic Volume (LVEDV)	Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.	At Baseline and 30 Days
Left Ventricle End Diastolic Volume (LVEDV)	Left Ventricular end-diastolic volume (LVEDV) as determined by the core echo laboratory. Left Ventricular end-diastolic volume (LVEDV) measured using 2-dimensional echocardiography. The endocardium is traced at end-diastole (frame before mitral valve closure or maximum cavity dimension) in the 2- and 4-chamber views to calculate volumes.	At Baseline and 12 months
Left Ventricular End Systolic Volume (LVESV)	Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.	At Baseline and Discharge (≤7 days of index procedure)
Left Ventricular End Systolic Volume (LVESV)	Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.	At Baseline and 30 Days
Left Ventricular End Systolic Volume (LVESV)	Left Ventricular end-systolic volume (LVESV) as determined by the core echo laboratory. Left Ventricular end-systolic volume (LVESV) measured using 2-dimensional echocardiography. The endocardium is traced at end-systole (frame prior to mitral valve opening or the minimum cavity area) in the 2- and 4-chamber views to calculate volumes.	At Baseline and 12 months
Left Ventricular Ejection Fraction (LVEF)	Left ventricular ejection fraction is assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks).	At Baseline and Discharge (≤7 days of index procedure)
Left Ventricular Ejection Fraction (LVEF)	Left ventricular ejection fraction is assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks).	At Baseline and 30 Days
Left Ventricular Ejection Fraction (LVEF)	Left ventricular ejection fraction is assessed by transthoracic echocardiography according to Simpson's rule (biplane method of disks).	At Baseline and 12 months
Number of Participants With MR Severity	Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography. MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe.	Baseline
Number of Participants With MR Severity	Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography. MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe.	At discharge (≤7 days of index procedure)
Number of Participants With MR Severity	Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography. MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe.	30 days
Number of Participants With MR Severity	Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography. MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe.	6 months
Number of Participants With MR Severity	Mitral regurgitation severity was determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity was scored using the integrative method based on qualitative and quantitative echocardiographic parameters as described in the ASE guidelines.Site-assessed mitral regurgitation severity using echocardiography. MR severity was graded as follows: 0: None, 1+: Mild, 2+: Moderate, 3+: Moderate-to-Severe, 4+: Severe.	12 months
Left Ventricular Internal Diameter End Diastole (LVIDd)	LVIDd is the measurements of the left ventricular internal dimension at end-diastole and normally corresponds to the largest cardiac dimension. LVIDd is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory.	At Baseline and Discharge (≤7 days of index procedure)
Left Ventricular Internal Diameter End Diastole (LVIDd)	LVIDd is the measurements of the left ventricular internal dimension at end-diastole and normally corresponds to the largest cardiac dimension. LVIDd is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory.	At Baseline and 30 Days
Left Ventricular Internal Diameter End Diastole (LVIDd)	LVIDd is the measurements of the left ventricular internal dimension at end-diastole and normally corresponds to the largest cardiac dimension. LVIDd is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory.	At Baseline and 12 Months
Left Ventricular Internal Diameter End Systole (LVIDs)	LVIDs is the measurements of the left ventricular internal dimension at end-systole and normally corresponds to the smallest cardiac dimension. LVIDs is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory.	At Baseline and Discharge (≤7 days of index procedure)
Left Ventricular Internal Diameter End Systole (LVIDs)	LVIDs is the measurements of the left ventricular internal dimension at end-systole and normally corresponds to the smallest cardiac dimension. LVIDs is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory.	At Baseline and 30 Days
Left Ventricular Internal Diameter End Systole (LVIDs)	LVIDs is the measurements of the left ventricular internal dimension at end-systole and normally corresponds to the smallest cardiac dimension. LVIDs is measured by transthoracic echocardiography and the results are interpreted by the study's echocardiography core laboratory.	At Baseline and 12 Months
Regurgitant Volume	Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.	At Baseline and Discharge (≤7 days of index procedure)
Regurgitant Volume	Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.	At Baseline and 30 Days
Regurgitant Volume	Regurgitant volume as determined by the core echo laboratory. In the presence of regurgitation of one valve, without any intracardiac shunt, the flow through the affected valve is larger than through other competent valves. The difference between the two represents the regurgitant volume.	At Baseline and 12 Months
Regurgitant Fraction	Regurgitant fraction as determined by the core echo laboratory. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.	At Baseline and Discharge (≤7 days of index procedure)
Regurgitant Fraction	Regurgitant fraction as determined by the core echo laboratory. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.	At Baseline and 30 Days
Regurgitant Fraction	Regurgitant fraction as determined by the core echo laboratory. Regurgitant fraction is defined as the regurgitant volume divided by the forward stroke volume through the regurgitant valve.	At Baseline and 12 Months
Mitral Valve Area (MVA) by Pressure Half-time (PHT)	Measure of the area of the mitral valve orifice using transthoracic echocardiography. The pressure half time method is used to assess the presence and severity of mitral stenosis. Results are interpreted by the study's echocardiography core laboratory.	At Baseline and Discharge (≤7 days of index procedure)
Mitral Valve Area (MVA) by Pressure Half-time (PHT)	Measure of the area of the mitral valve orifice using transthoracic echocardiography. The pressure half time method is used to assess the presence and severity of mitral stenosis. Results are interpreted by the study's echocardiography core laboratory.	At Baseline and 30 Days
Mitral Valve Area (MVA) by Pressure Half-time (PHT)	Measure of the area of the mitral valve orifice using transthoracic echocardiography. The pressure half time method is used to assess the presence and severity of mitral stenosis. Results are interpreted by the study's echocardiography core laboratory.	At Baseline and 12 Months
Mitral Valve Mean Gradient	Mitral valve mean gradient is defined as the mean pressure gradients across the mitral valve as measured by echocardiography.	At Baseline and Discharge (≤7 days of index procedure)
Mitral Valve Mean Gradient	Mitral valve mean gradient is defined as the mean pressure gradients across the mitral valve as measured by echocardiography.	At Baseline and 30 Days
Mitral Valve Mean Gradient	Mitral valve mean gradient is defined as the mean pressure gradients across the mitral valve as measured by echocardiography.	At Baseline and 12 Months
Left Atrial Volume	Left atrial volume is assessed by echocardiography. Using the single plane method of disks, the left atrial volume is derived by planimetry in the 4-chamber view at end-systole.	At Baseline and Discharge (≤7 days of index procedure)
Left Atrial Volume	Left atrial volume is assessed by echocardiography. Using the single plane method of disks, the left atrial volume is derived by planimetry in the 4-chamber view at end-systole.	At Baseline and 30 Days
Left Atrial Volume	Left atrial volume is assessed by echocardiography. Using the single plane method of disks, the left atrial volume is derived by planimetry in the 4-chamber view at end-systole.	At Baseline and 12 Months
Six Minute Walking Distance	The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. It is a measure of a patient's exercise capacity.	Baseline
Six Minute Walking Distance	The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. It is a measure of a patient's exercise capacity.	30 days
Six Minute Walking Distance	The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. It is a measure of a patient's exercise capacity.	6 months
Six Minute Walking Distance	The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. It is a measure of a patient's exercise capacity.	12 months
Percentage of Participants With 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.	Baseline
Percentage of Participants With 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.	30 days
Percentage of Participants With 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.	6 months
Percentage of Participants With 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.	12 months
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 30 Days	The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower&higher MLHFQ score indicates less effect of heart failure&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL. The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)&c) other factors,measured using 8 questions (possible subscale score from 0-40).	30 days
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 6 Months	The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower&higher MLHFQ score indicates less effect of heart failure&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL. The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)&c) other factors,measured using 8 questions (possible subscale score from 0-40).	6 months
Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life (QOL) Score From Baseline to 12 Months	The Minnesota Living with Heart Failure Questionnaire(MLHFQ) is comprised of 21 questions.The response for each question ranges from 0(no affect on the patient's living) to 5(affected the patient's life very much during the past month).The total score for the 21 items can range from 0-105.A lower&higher MLHFQ score indicates less effect of heart failure&the worse impact of heart failure on a patient's QOL,respectively.Although the MLHFQ incorporates relevant aspects of the key dimensions of QOL (physical and emotional),the questionnaire was not designed to measure any particular dimension separately.The total score should be taken as the best measure of how heart failure and treatments impact QOL. The total score is the sum of a)the physical dimension,measured using 8 questions (possible subscale score range 0-40) b)the emotional dimension,measured using 5 questions(possible subscale score from 0-25)&c) other factors,measured using 8 questions (possible subscale score from 0-40).	12 months
Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)	Death: 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: Acute myocardial infarction; Cardiac perforation/pericardial tamponade; Arrhythmia or conduction abnormality; Stroke within 30 days of the procedure or stroke suspected of being related to the procedure; Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; 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). Congestive Heart Failure (CHF): Defined as a documented diagnosis of CHF on the hospital admission report or discharge summary.	Baseline
Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)	Death: 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: Acute myocardial infarction; Cardiac perforation/pericardial tamponade; Arrhythmia or conduction abnormality; Stroke within 30 days of the procedure or stroke suspected of being related to the procedure; Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; 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). Congestive Heart Failure (CHF): Defined as a documented diagnosis of CHF on the hospital admission report or discharge summary.	30 days
Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)	Death: 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: Acute myocardial infarction; Cardiac perforation/pericardial tamponade; Arrhythmia or conduction abnormality; Stroke within 30 days of the procedure or stroke suspected of being related to the procedure; Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; 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). Congestive Heart Failure (CHF): Defined as a documented diagnosis of CHF on the hospital admission report or discharge summary.	6 months
Percentage of Participants Experiencing Freedom From Death and Congestive Heart Failure (Kaplan-Meier Curve Analysis)	Death: 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: Acute myocardial infarction; Cardiac perforation/pericardial tamponade; Arrhythmia or conduction abnormality; Stroke within 30 days of the procedure or stroke suspected of being related to the procedure; Death due to any complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; 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). Congestive Heart Failure (CHF): Defined as a documented diagnosis of CHF on the hospital admission report or discharge summary.	12 months
Number of Participants With Mitral Valve Surgery	Mital Valve Surgery Post-MitraClip Procedure; Surgery Types includes Replacement and Repair.	30 days of Post-MitraClip Procedure
Number of Participants With Second Intervention to Place an Additional MitraClip Device	Second MitraClip device interventions are reported by Abbott Vascular personnel on Procedural Observation Forms. A second MitraClip device intervention is a good option for patients with MR following placement of the original MitraClip device.	Through 12 months
Rate of Patients Rehospitalized	Defined as re-admission of patients to the hospital following discharge from the Clip procedure.	30 days
Duration of Rehospitalization		30 days
Number of Participants at Discharge Facility	This is the economic data reported to support the MitraClip System economic analysis.	< or = 12 days
Post-procedure Intensive Care Unit (ICU)/Critical Care Unit (CCU)/Post-anesthesia Care Unit (PACU) Duration	ICU and hospital stay is defined as the mean duration of time that patients spent in the ICU (Intensive Care Unit)/ CCU (Cardiac Care Unit)/ PACU (Post-Anesthesia Care Unit) following the MitraClip procedure.	Post index procedure within 30 days
Post-procedure Hospital Stay	This is the Economic data reported to support the MitraClip System economic analysis. It is defined as the mean duration of time that patients spent in hospital following the MitraClip procedure.	Post index procedure within 30 days

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Collaborators: Abbott
• Investigators: Principal Investigator: David Muller, MD, St Vincent's Hospital - Sydney, Australia; Principal Investigator: Jurgen Passage, FRACs, Sir Charles Gairdner Hospital, Perth, Australia

Publications and helpful links

General Publications

• Rogers JH, Yeo KK, Carroll JD, Cleveland J, Reece TB, Gillinov AM, Rodriguez L, Whitlow P, Woo YJ, Herrmann HC, Young JN. Late surgical mitral valve repair after percutaneous repair with the MitraClip system. J Card Surg. 2009 Nov-Dec;24(6):677-81. doi: 10.1111/j.1540-8191.2009.00901.x. Epub 2009 Jul 24.
• Feldman T, Kar S, Rinaldi M, Fail P, Hermiller J, Smalling R, Whitlow PL, Gray W, Low R, Herrmann HC, Lim S, Foster E, Glower D; EVEREST Investigators. Percutaneous mitral repair with the MitraClip system: safety and midterm durability in the initial EVEREST (Endovascular Valve Edge-to-Edge REpair Study) cohort. J Am Coll Cardiol. 2009 Aug 18;54(8):686-94. doi: 10.1016/j.jacc.2009.03.077.
• Herrmann HC, Kar S, Siegel R, Fail P, Loghin C, Lim S, Hahn R, Rogers JH, Bommer WJ, Wang A, Berke A, Lerakis S, Kramer P, Wong SC, Foster E, Glower D, Feldman T; EVEREST Investigators. Effect of percutaneous mitral repair with the MitraClip device on mitral valve area and gradient. EuroIntervention. 2009 Jan;4(4):437-42. doi: 10.4244/eijv4i4a76.
• Luk A, Butany J, Ahn E, Fann JI, St Goar F, Thornton T, McDermott L, Madayag C, Komtebedde J. Mitral repair with the Evalve MitraClip device: histopathologic findings in the porcine model. Cardiovasc Pathol. 2009 Sep-Oct;18(5):279-85. doi: 10.1016/j.carpath.2008.07.001. Epub 2008 Aug 13.
• Silvestry FE, Rodriguez LL, Herrmann HC, Rohatgi S, Weiss SJ, Stewart WJ, Homma S, Goyal N, Pulerwitz T, Zunamon A, Hamilton A, Merlino J, Martin R, Krabill K, Block PC, Whitlow P, Tuzcu EM, Kapadia S, Gray WA, Reisman M, Wasserman H, Schwartz A, Foster E, Feldman T, Wiegers SE. Echocardiographic guidance and assessment of percutaneous repair for mitral regurgitation with the Evalve MitraClip: lessons learned from EVEREST I. J Am Soc Echocardiogr. 2007 Oct;20(10):1131-40. doi: 10.1016/j.echo.2007.02.003. Epub 2007 Jun 13.
• Borgia F, Di Mario C, Franzen O. Adenosine-induced asystole to facilitate MitraClip placement in a patient with adverse mitral valve morphology. Heart. 2011 May;97(10):864. doi: 10.1136/hrt.2010.208132. Epub 2010 Oct 29. No abstract available.
• Tamburino C, Imme S, Barbanti M, Mule M, Pistritto AM, Aruta P, Cammalleri V, Scarabelli M, Mangiafico S, Scandura S, Ussia GP. Reduction of mitral valve regurgitation with Mitraclip(R) percutaneous system. Minerva Cardioangiol. 2010 Oct;58(5):589-98.
• Ciobanu A, Bennett S, Azam M, Clark A, Vinereanu D. Incremental value of three-dimensional transoesophageal echocardiography for guiding double percutaneous MitraClip (R) implantation in a 'no option' patient. Eur J Echocardiogr. 2011 Feb;12(2):E11. doi: 10.1093/ejechocard/jeq118. Epub 2010 Sep 27.
• Lim DS, Kunjummen BJ, Smalling R. Mitral valve repair with the MitraClip device after prior surgical mitral annuloplasty. Catheter Cardiovasc Interv. 2010 Sep 1;76(3):455-9. doi: 10.1002/ccd.22547.
• Kalarus Z, Kukulski T, Lekston A, Streb W, Sikora J, Nadziakiewicz P, Gasior M, Polonski L, Zembala M. [Methodology and safety of transvascular reduction of severe ischaemic mitral insufficiency with MitraClip in high-surgical-risk patients - first three cases in Poland]. Kardiol Pol. 2010 Jun;68(6):729-35. Polish.
• Geidel S, Ostermeyer J, Lass M, Schmoeckel M. Complex surgical valve repair after failed percutaneous mitral intervention using the MitraClip device. Ann Thorac Surg. 2010 Jul;90(1):277-9. doi: 10.1016/j.athoracsur.2009.12.048.
• Mauri L, Garg P, Massaro JM, Foster E, Glower D, Mehoudar P, Powell F, Komtebedde J, McDermott E, Feldman T. The EVEREST II Trial: design and rationale for a randomized study of the evalve mitraclip system compared with mitral valve surgery for mitral regurgitation. Am Heart J. 2010 Jul;160(1):23-9. doi: 10.1016/j.ahj.2010.04.009.
• Jonsson A, Settergren M. MitraClip catheter-based mitral valve repair system. Expert Rev Med Devices. 2010 Jul;7(4):439-47. doi: 10.1586/erd.10.23.
• Ussia GP, Barbanti M, Tamburino C. Feasibility of percutaneous transcatheter mitral valve repair with the MitraClip system using conscious sedation. Catheter Cardiovasc Interv. 2010 Jun 1;75(7):1137-40. doi: 10.1002/ccd.22415.
• Tamburino C, Ussia GP, Maisano F, Capodanno D, La Canna G, Scandura S, Colombo A, Giacomini A, Michev I, Mangiafico S, Cammalleri V, Barbanti M, Alfieri O. Percutaneous mitral valve repair with the MitraClip system: acute results from a real world setting. Eur Heart J. 2010 Jun;31(11):1382-9. doi: 10.1093/eurheartj/ehq051. Epub 2010 Mar 18.
• Franzen O, Baldus S, Rudolph V, Meyer S, Knap M, Koschyk D, Treede H, Barmeyer A, Schofer J, Costard-Jackle A, Schluter M, Reichenspurner H, Meinertz T. Acute outcomes of MitraClip therapy for mitral regurgitation in high-surgical-risk patients: emphasis on adverse valve morphology and severe left ventricular dysfunction. Eur Heart J. 2010 Jun;31(11):1373-81. doi: 10.1093/eurheartj/ehq050. Epub 2010 Mar 10.
• Argenziano M, Skipper E, Heimansohn D, Letsou GV, Woo YJ, Kron I, Alexander J, Cleveland J, Kong B, Davidson M, Vassiliades T, Krieger K, Sako E, Tibi P, Galloway A, Foster E, Feldman T, Glower D; EVEREST Investigators. Surgical revision after percutaneous mitral repair with the MitraClip device. Ann Thorac Surg. 2010 Jan;89(1):72-80; discussion p 80. doi: 10.1016/j.athoracsur.2009.08.063.
• Whitlow PL, Feldman T, Pedersen WR, Lim DS, Kipperman R, Smalling R, Bajwa T, Herrmann HC, Lasala J, Maddux JT, Tuzcu M, Kapadia S, Trento A, Siegel RJ, Foster E, Glower D, Mauri L, Kar S; EVEREST II Investigators. Acute and 12-month results with catheter-based mitral valve leaflet repair: the EVEREST II (Endovascular Valve Edge-to-Edge Repair) High Risk Study. J Am Coll Cardiol. 2012 Jan 10;59(2):130-9. doi: 10.1016/j.jacc.2011.08.067.
• Herrmann HC, Rohatgi S, Wasserman HS, Block P, Gray W, Hamilton A, Zunamon A, Homma S, Di Tullio MR, Kraybill K, Merlino J, Martin R, Rodriguez L, Stewart WJ, Whitlow P, Wiegers SE, Silvestry FE, Foster E, Feldman T. Mitral valve hemodynamic effects of percutaneous edge-to-edge repair with the MitraClip device for mitral regurgitation. Catheter Cardiovasc Interv. 2006 Dec;68(6):821-8. doi: 10.1002/ccd.20917.
• Feldman T, Foster E, Glower DD, Kar S, Rinaldi MJ, Fail PS, Smalling RW, Siegel R, Rose GA, Engeron E, Loghin C, Trento A, Skipper ER, Fudge T, Letsou GV, Massaro JM, Mauri L; EVEREST II Investigators. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011 Apr 14;364(15):1395-406. doi: 10.1056/NEJMoa1009355. Epub 2011 Apr 4. Erratum In: N Engl J Med. 2011 Jul 14;365(2):189. Glower, Donald G [corrected to Glower, Donald D].
• Ladich E, Michaels MB, Jones RM, McDermott E, Coleman L, Komtebedde J, Glower D, Argenziano M, Feldman T, Nakano M, Virmani R; Endovascular Valve Edge-to-Edge Repair Study (EVEREST) Investigators. Pathological healing response of explanted MitraClip devices. Circulation. 2011 Apr 5;123(13):1418-27. doi: 10.1161/CIRCULATIONAHA.110.978130. Epub 2011 Mar 21.
• Siegel RJ, Biner S, Rafique AM, Rinaldi M, Lim S, Fail P, Hermiller J, Smalling R, Whitlow PL, Herrmann HC, Foster E, Feldman T, Glower D, Kar S; EVEREST Investigators. The acute hemodynamic effects of MitraClip therapy. J Am Coll Cardiol. 2011 Apr 19;57(16):1658-65. doi: 10.1016/j.jacc.2010.11.043.
• Grayburn PA, Roberts BJ, Aston S, Anwar A, Hebeler RF Jr, Brown DL, Mack MJ. Mechanism and severity of mitral regurgitation by transesophageal echocardiography in patients referred for percutaneous valve repair. Am J Cardiol. 2011 Sep 15;108(6):882-7. doi: 10.1016/j.amjcard.2011.05.013. Epub 2011 Jul 7.
• Nor Aripin KN, Sammons HM, Choonara I. Published pediatric randomized drug trials in developing countries, 1996-2002. Paediatr Drugs. 2010 Apr 1;12(2):99-103. doi: 10.2165/11316260-000000000-00000.
• Auricchio A, Schillinger W, Meyer S, Maisano F, Hoffmann R, Ussia GP, Pedrazzini GB, van der Heyden J, Fratini S, Klersy C, Komtebedde J, Franzen O; PERMIT-CARE Investigators. Correction of mitral regurgitation in nonresponders to cardiac resynchronization therapy by MitraClip improves symptoms and promotes reverse remodeling. J Am Coll Cardiol. 2011 Nov 15;58(21):2183-9. doi: 10.1016/j.jacc.2011.06.061.
• Conradi L, Treede H, Franzen O, Seiffert M, Baldus S, Schirmer J, Meinertz T, Reichenspurner H. Impact of MitraClip therapy on secondary mitral valve surgery in patients at high surgical risk. Eur J Cardiothorac Surg. 2011 Dec;40(6):1521-6. doi: 10.1016/j.ejcts.2011.03.007. Epub 2011 Apr 15.
• Divchev D, Kische S, Paranskaya L, Schneider H, Rehders T, Ortak J, Akin I, Turan G, Turan CH, Steinhoff G, Noldge-Schomburg G, Nienaber CA, Ince H. In-hospital outcome of patients with severe mitral valve regurgitation classified as inoperable and treated with the MitraClip(R) device. J Interv Cardiol. 2012 Apr;25(2):180-9. doi: 10.1111/j.1540-8183.2011.00688.x. Epub 2011 Dec 21.
• Franzen O, van der Heyden J, Baldus S, Schluter M, Schillinger W, Butter C, Hoffmann R, Corti R, Pedrazzini G, Swaans MJ, Neuss M, Rudolph V, Surder D, Grunenfelder J, Eulenburg C, Reichenspurner H, Meinertz T, Auricchio A. MitraClip(R) therapy in patients with end-stage systolic heart failure. Eur J Heart Fail. 2011 May;13(5):569-76. doi: 10.1093/eurjhf/hfr029. Epub 2011 Apr 6.
• Gaemperli O, Moccetti M, Surder D, Biaggi P, Hurlimann D, Kretschmar O, Buehler I, Bettex D, Felix C, Luscher TF, Falk V, Grunenfelder J, Corti R. Acute haemodynamic changes after percutaneous mitral valve repair: relation to mid-term outcomes. Heart. 2012 Jan;98(2):126-32. doi: 10.1136/heartjnl-2011-300705. Epub 2011 Oct 7.
• Pleger ST, Mereles D, Schulz-Schonhagen M, Krumsdorf U, Chorianopoulos E, Rottbauer W, Katus HA, Bekeredjian R. Acute safety and 30-day outcome after percutaneous edge-to-edge repair of mitral regurgitation in very high-risk patients. Am J Cardiol. 2011 Nov 15;108(10):1478-82. doi: 10.1016/j.amjcard.2011.06.069. Epub 2011 Sep 3.
• Rudolph V, Knap M, Franzen O, Schluter M, de Vries T, Conradi L, Schirmer J, Treede H, Wegscheider K, Costard-Jackle A, Meinertz T, Reichenspurner H, Baldus S. Echocardiographic and clinical outcomes of MitraClip therapy in patients not amenable to surgery. J Am Coll Cardiol. 2011 Nov 15;58(21):2190-5. doi: 10.1016/j.jacc.2011.07.047.
• Schillinger W, Athanasiou T, Weicken N, Berg L, Tichelbacker T, Puls M, Hunlich M, Wachter R, Helms HJ, Seipelt R, Schondube FA, Hasenfuss G. Impact of the learning curve on outcomes after percutaneous mitral valve repair with MitraClip and lessons learned after the first 75 consecutive patients. Eur J Heart Fail. 2011 Dec;13(12):1331-9. doi: 10.1093/eurjhf/hfr141. Epub 2011 Oct 24. Erratum In: Eur J Heart Fail. 2012 Jun;14(6):679.
• Treede H, Schirmer J, Rudolph V, Franzen O, Knap M, Schluter M, Conradi L, Seiffert M, Koschyk D, Meinertz T, Baldus S, Reichenspurner H. A heart team's perspective on interventional mitral valve repair: percutaneous clip implantation as an important adjunct to a surgical mitral valve program for treatment of high-risk patients. J Thorac Cardiovasc Surg. 2012 Jan;143(1):78-84. doi: 10.1016/j.jtcvs.2011.09.033. Epub 2011 Oct 27.
• Ussia GP, Cammalleri V, Sarkar K, Scandura S, Imme S, Pistritto AM, Caggegi A, Chiaranda M, Mangiafico S, Barbanti M, Scarabelli M, Mule M, Aruta P, Tamburino C. Quality of life following percutaneous mitral valve repair with the MitraClip System. Int J Cardiol. 2012 Mar 8;155(2):194-200. doi: 10.1016/j.ijcard.2011.08.853. Epub 2011 Sep 28.
• Chan PH, Di Mario C, Franzen O. Dissociation between anatomical and functional results after MitraClip implantation. Int J Cardiol. 2012 Mar 8;155(2):175-6. doi: 10.1016/j.ijcard.2011.10.047. Epub 2011 Nov 9. No abstract available.
• Rogers JH, Bolling SF. Editorial comment: Surgery after MitraClip therapy: you can't win them all. Eur J Cardiothorac Surg. 2011 Dec;40(6):1526-8. doi: 10.1016/j.ejcts.2011.04.024. Epub 2011 Jun 12. No abstract available.
• Turi ZG, Rosenbloom M. An option for the high-comorbidity patient with mitral regurgitation. J Am Coll Cardiol. 2012 Jan 10;59(2):140-2. doi: 10.1016/j.jacc.2011.09.049. No abstract available.
• Altiok E, Becker M, Hamada S, Reith S, Marx N, Hoffmann R. Optimized guidance of percutaneous edge-to edge repair of the mitral valve using real-time 3-D transesophageal echocardiography. Clin Res Cardiol. 2011 Aug;100(8):675-81. doi: 10.1007/s00392-011-0296-1. Epub 2011 Mar 3.
• Bergsland J, Mujanovic E, Elle OJ, Mirtaheri P, Fosse E. Minimally invasive repair of the mitral valve: technological and clinical developments. Minim Invasive Ther Allied Technol. 2011 Apr;20(2):72-7. doi: 10.3109/13645706.2011.554843.
• Biner S, Perk G, Kar S, Rafique AM, Slater J, Shiota T, Hussaini A, Chou S, Kronzon I, Siegel RJ. Utility of combined two-dimensional and three-dimensional transesophageal imaging for catheter-based mitral valve clip repair of mitral regurgitation. J Am Soc Echocardiogr. 2011 Jun;24(6):611-7. doi: 10.1016/j.echo.2011.02.005. Epub 2011 Mar 23.
• Buch MH, Trento A, Kar S. Is there a role for surgeons in transcatheter mitral valve procedures? Curr Opin Cardiol. 2011 Mar;26(2):99-105. doi: 10.1097/HCO.0b013e32834398a0.
• Chiam PT, Ruiz CE. Percutaneous transcatheter mitral valve repair: a classification of the technology. JACC Cardiovasc Interv. 2011 Jan;4(1):1-13. doi: 10.1016/j.jcin.2010.09.023.
• Cikirikcioglu M, Cherian S, Schussler O, Kalangos A. Regarding "The EVEREST II Trial: design and rationale for a randomized study of the Evalve MitraClip system compared with mitral valve surgery for mitral regurgitation". Am Heart J. 2011 Jul;162(1):e11-2; author reply e13. doi: 10.1016/j.ahj.2011.04.004. Epub 2011 Jun 12. No abstract available.
• Cleland JG, Coletta AP, Freemantle N, Clark AL. Clinical trials update from the American College of Cardiology Meeting 2011: STICH, NorthStar, TARGET, and EVEREST II. Eur J Heart Fail. 2011 Jul;13(7):805-8. doi: 10.1093/eurjhf/hfr077.
• Dixon SR, Grines CL, O'Neill WW. The year in interventional cardiology. J Am Coll Cardiol. 2010 May 18;55(20):2272-86. doi: 10.1016/j.jacc.2010.02.024. No abstract available.
• Dudiy Y, Jelnin V, Ruiz CE. Percutaneous mitral valve treatment. Minerva Cardioangiol. 2011 Oct;59(5):507-18.
• Farouque HM, Clark DJ. Percutaneous mitral valve leaflet repair for mitral regurgitation: NICE guidance. Heart. 2010 Mar;96(5):385-7. doi: 10.1136/hrt.2009.183269. No abstract available.
• Feldman T, Cilingiroglu M. Percutaneous leaflet repair and annuloplasty for mitral regurgitation. J Am Coll Cardiol. 2011 Feb 1;57(5):529-37. doi: 10.1016/j.jacc.2010.10.012.
• George JC, Varghese V, Dangas G, Feldman TE. Percutaneous mitral valve repair: lessons from the EVEREST II (Endovascular Valve Edge-to-Edge REpair Study) and beyond. JACC Cardiovasc Interv. 2011 Jul;4(7):825-7. doi: 10.1016/j.jcin.2011.05.010. No abstract available.
• Goldberg SL, Feldman T. Percutaneous mitral valve interventions: overview of new approaches. Curr Cardiol Rep. 2010 Sep;12(5):404-12. doi: 10.1007/s11886-010-0130-9.
• Hussaini A, Kar S. Percutaneous mitral valve repair: potential in heart failure management. Curr Heart Fail Rep. 2010 Mar;7(1):22-6. doi: 10.1007/s11897-010-0006-8.
• Jilaihawi H, Hussaini A, Kar S. MitraClip: a novel percutaneous approach to mitral valve repair. J Zhejiang Univ Sci B. 2011 Aug;12(8):633-7. doi: 10.1631/jzus.B1101009.
• Lam YY, Lee PW, Yong G, Yan BP. Investigational devices for mitral regurgitation: state of the art. Expert Rev Med Devices. 2011 Jan;8(1):105-14. doi: 10.1586/erd.10.52.
• Maisano F, Godino C, Giacomini A, Denti P, Arendar I, Buzzatti N, Canna GL, Alfieri O, Colombo A. Clinical trial experience with the MitraClip catheter based mitral valve repair system. Int J Cardiovasc Imaging. 2011 Dec;27(8):1155-64. doi: 10.1007/s10554-011-9872-8. Epub 2011 Apr 19.
• Maisano F, Alfieri O, La Canna G. Percutaneous mitral repair with the MitraClip. Ann Fr Anesth Reanim. 2011 May;30 Suppl 1:S33-7. doi: 10.1016/S0750-7658(11)70008-9.
• Maisano F, Godino C, Giacomini A, Denti P, Buzzatti N, Arendar I, Colombo A, Alfieri O, La Canna G. Patient selection for MitraClip therapy impaired left ventricular systolic function. Minerva Cardioangiol. 2011 Oct;59(5):455-71.
• Maisano F, La Canna G, Colombo A, Alfieri O. The evolution from surgery to percutaneous mitral valve interventions: the role of the edge-to-edge technique. J Am Coll Cardiol. 2011 Nov 15;58(21):2174-82. doi: 10.1016/j.jacc.2011.07.046.
• Ong SH, Beucher H, Mueller R, Gerckens U, Boekstegers P. Percutaneous double-valve interventions for aortic stenosis and pure mitral regurgitation. Am J Cardiol. 2011 Sep 15;108(6):893-5. doi: 10.1016/j.amjcard.2011.05.017. Epub 2011 Jul 2.
• Padala M, Keeling WB, Guyton RA, Thourani VH. Innovations in therapies for heart valve disease. Circ J. 2011;75(5):1028-41. doi: 10.1253/circj.cj-11-0289. Epub 2011 Apr 9.
• Rogers JH, Franzen O. Percutaneous edge-to-edge MitraClip therapy in the management of mitral regurgitation. Eur Heart J. 2011 Oct;32(19):2350-7. doi: 10.1093/eurheartj/ehr101. Epub 2011 May 23.
• Saroul C, Keller G, Benaissa M, Lehot JJ. [Anesthesia for minimally invasive cardiac procedure]. Ann Fr Anesth Reanim. 2011 May;30 Suppl 1:S38-43. doi: 10.1016/S0750-7658(11)70009-0. French.
• Seeburger J, Katus HA, Pleger ST, Krumsdorf U, Mohr FW, Bekeredjian R. Percutaneous and surgical treatment of mitral valve regurgitation. Dtsch Arztebl Int. 2011 Dec;108(48):816-21. doi: 10.3238/arztebl.2011.0816. Epub 2011 Dec 2.
• Taramasso M, Cioni M, Giacomini A, Michev I, Godino C, Montorfano M, Colombo A, Alfieri O, Maisano F. Emerging approaches of transcatheter valve repair/insertion. Cardiol Res Pract. 2010 Jul 25;2010:540749. doi: 10.4061/2010/540749.
• Taylor J. The percutaneous approach to mitral valve repair. Eur Heart J. 2011 Feb;32(3):249-51. doi: 10.1093/eurheartj/ehq463. No abstract available.
• Vahanian A, Himbert D, Brochet E, Messika-Zeitoun D. Percutaneous mitral valve repair: the beginning of the end or the end of the beginning? F1000 Med Rep. 2010 Mar 25;2:21. doi: 10.3410/M2-21.
• Van Mieghem NM, Piazza N, Anderson RH, Tzikas A, Nieman K, De Laat LE, McGhie JS, Geleijnse ML, Feldman T, Serruys PW, de Jaegere PP. Anatomy of the mitral valvular complex and its implications for transcatheter interventions for mitral regurgitation. J Am Coll Cardiol. 2010 Aug 17;56(8):617-26. doi: 10.1016/j.jacc.2010.04.030.
• Walenta K, Sinning JM, Werner C, Bohm M. Hotline update of clinical trials and registries presented at the at the European Society of Cardiology Congress in Paris 2011. Clin Res Cardiol. 2011 Nov;100(11):955-71. doi: 10.1007/s00392-011-0370-8. Epub 2011 Sep 30.
• Yuksel UC, Kapadia SR, Tuzcu EM. Percutaneous mitral repair: patient selection, results, and future directions. Curr Cardiol Rep. 2011 Apr;13(2):100-6. doi: 10.1007/s11886-010-0158-x.
• Altiok E, Paetsch I, Jahnke C, Brehmer K, Reith S, Becker M, Marx N, Hoffmann R. Percutaneous edge-to-edge mitral valve repair: assessment of immediate post-procedural treatment effect using color 3-dimensional transesophageal echocardiography and cardiac magnetic resonance imaging. J Am Coll Cardiol. 2011 Sep 6;58(11):e21. doi: 10.1016/j.jacc.2010.11.088. No abstract available.
• Barbanti M, Ussia GP, Tamburino C. Percutaneous treatment of aortic stenosis and mitral regurgitation in the same patient: first human cases description. Catheter Cardiovasc Interv. 2011 Oct 1;78(4):650-5. doi: 10.1002/ccd.23015. Epub 2011 Jul 25.
• Bekeredjian R, Mereles D, Pleger S, Krumsdorf U, Katus HA, Rottbauer W. Large atrial thrombus formation after MitraClip implantation: is anticoagulation mandatory? J Heart Valve Dis. 2011 Mar;20(2):146-8.
• Conradi L, Treede H, Baldus S, Seiffert M, Blankenberg S, Reichenspurner H. [Treating mitral regurgitation: a surgical and interventional update]. Herz. 2011 Dec;36(8):677-85. doi: 10.1007/s00059-011-3531-7. German.
• Franzen O, von Samson P, Dodge-Khatami A, Geffert G, Baldus S. Percutaneous edge-to-edge repair of tricuspid regurgitation in congenitally corrected transposition of the great arteries. Congenit Heart Dis. 2011 Jan-Feb;6(1):57-9. doi: 10.1111/j.1747-0803.2010.00428.x.
• Franzen O, Seiffert M, Baldus S, Conradi L, Schirmer J, Kubik M, Meinertz T, Reichenspurner H, Treede H. Percutaneous mitral valve repair as a bail-out strategy for patients with severe mitral regurgitation after cardiac surgery. J Thorac Cardiovasc Surg. 2011 Jul;142(1):227-30. doi: 10.1016/j.jtcvs.2010.10.037. Epub 2011 Jan 17. No abstract available.
• Ihlemann N, Franzen O, Jorgensen E, Hansen PB, Hassager C, Moller JE, Sondergaard L. Promising results after percutaneous mitral valve repair. Dan Med Bull. 2011 Jul;58(7):A4299.
• Kische S, Nienaber C, Ince H. Use of four MitraClip devices in a patient with ischemic cardiomyopathy and mitral regurgitation: "zipping by clipping". Catheter Cardiovasc Interv. 2012 Nov 15;80(6):1007-13. doi: 10.1002/ccd.23431. Epub 2012 Jan 10.
• Kluge JG, Hagendorff A, Pfeiffer D, Jurisch D, Tarr A. Active infective prosthetic endocarditis after percutaneous edge-to-edge mitral valve repair. Eur J Echocardiogr. 2011 Sep;12(9):710. doi: 10.1093/ejechocard/jer062. Epub 2011 Jul 23. No abstract available.
• Madder RD, Safian RD, Gallagher M, Senter SR, Hanzel GS. The first report of transcatheter aortic valve implantation and percutaneous mitral valve repair in the same patient. JACC Cardiovasc Interv. 2011 Jul;4(7):824. doi: 10.1016/j.jcin.2011.05.009. No abstract available.
• Mayr NP, Martin K, Hausleiter J, Brown A, Tassani P. Ventilation manoeuvres facilitate MitraClip placement. Heart. 2011 Oct;97(20):1717; author reply 1717. doi: 10.1136/heartjnl-2011-300587. Epub 2011 Jul 31. No abstract available.
• Paranskaya L, Turan I, Kische S, Nienaber C, Ince H. Rapid pacing facilitates grasping and MitraClip implantation in severe mitral leaflet prolapse. Clin Res Cardiol. 2012 Jan;101(1):69-71. doi: 10.1007/s00392-011-0384-2. Epub 2011 Nov 19. No abstract available.
• Surder D, Altwegg L, Hurlimann D, Felix C, Grunenfelder J, Corti R. Percutaneous double valve intervention. Eur Heart J. 2011 Mar;32(5):636. doi: 10.1093/eurheartj/ehq378. Epub 2010 Nov 23. No abstract available.
• Van den Branden BJ, Post MC, Swaans MJ, Rensing BJ, Eefting FD, Plokker HW, Jaarsma W, Van der Heyden JA. Percutaneous mitral valve repair using the edge-to-edge technique in a high-risk population. Neth Heart J. 2010 Sep;18(9):437-43. doi: 10.1007/BF03091811.
• Van den Branden BJ, Swaans MJ, Post MC, Rensing BJ, Eefting FD, Jaarsma W, Van der Heyden JA. Redo mitral valve clipping after partial clip detachment. JACC Cardiovasc Interv. 2010 Feb;3(2):251-2. doi: 10.1016/j.jcin.2009.09.018. No abstract available.
• Zuern CS, Schreieck J, Weig HJ, Gawaz M, May AE. Percutaneous mitral valve repair using the MitraClip in acute cardiogenic shock. Clin Res Cardiol. 2011 Aug;100(8):719-21. doi: 10.1007/s00392-011-0324-1. Epub 2011 May 24. No abstract available.
• Alfieri O, Denti P. Alfieri stitch and its impact on mitral clip. Eur J Cardiothorac Surg. 2011 Jun;39(6):807-8. doi: 10.1016/j.ejcts.2011.01.017. Epub 2011 Feb 25. No abstract available.
• Asgar AW, Khairy P. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011 Jul 7;365(1):90; author reply 91. doi: 10.1056/NEJMc1105564. No abstract available.
• Gorman RC, Gillespie MJ, Gorman JH 3rd. Percutaneous repair or surgery for mitral regurgitation. N Engl J Med. 2011 Jul 7;365(1):90-1; author reply 91. doi: 10.1056/NEJMc1105564. No abstract available.
• Murphy MO, Ahmed K, Athanasiou T. Surgery for chronic ischemic mitral regurgitation - which mitral intervention? Expert Rev Cardiovasc Ther. 2011 May;9(5):587-97. doi: 10.1586/erc.11.50.
• Osorio J, Fuster V. Valve interventions-a word of caution. Nat Rev Cardiol. 2010 Jul;7(7):355. doi: 10.1038/nrcardio.2010.83. No abstract available.
• Otto CM, Verrier ED. Mitral regurgitation--what is best for my patient? N Engl J Med. 2011 Apr 14;364(15):1462-3. doi: 10.1056/NEJMe1102013. Epub 2011 Apr 4. No abstract available.
• Skipper ER, Accola KD, Sade RM. Must surgeons tell mitral valve repair candidates about a new percutaneous repair device that is only available elsewhere? Ann Thorac Surg. 2011 Oct;92(4):1163-9. doi: 10.1016/j.athoracsur.2011.04.096. No abstract available.
• Thompson KA, Philip KJ, Simsir S, Schwarz ER. The new concept of ''interventional heart failure therapy'': part 2--inotropes, valvular disease, pumps, and transplantation. J Cardiovasc Pharmacol Ther. 2010 Sep;15(3):231-43. doi: 10.1177/1074248410369111. Epub 2010 Jul 1.
• Vahanian A, Iung B. 'Edge to edge' percutaneous mitral valve repair in mitral regurgitation: it can be done but should it be done? Eur Heart J. 2010 Jun;31(11):1301-4. doi: 10.1093/eurheartj/ehq088. Epub 2010 Apr 11. No abstract available.
• Vahanian A, Iung B, Himbert D, Nataf P. Changing demographics of valvular heart disease and impact on surgical and transcatheter valve therapies. Int J Cardiovasc Imaging. 2011 Dec;27(8):1115-22. doi: 10.1007/s10554-011-9804-7. Epub 2011 Feb 24.
• van den Heuvel AF, Alfieri O, Mariani MA. MitraClip in end-stage heart failure: a realistic alternative to surgery? Eur J Heart Fail. 2011 May;13(5):472-4. doi: 10.1093/eurjhf/hfr038. No abstract available.
• Altiok E, Becker M, Hamada S, Grabskaya E, Reith S, Marx N, Hoffmann R. Real-time 3D TEE allows optimized guidance of percutaneous edge-to-edge repair of the mitral valve. JACC Cardiovasc Imaging. 2010 Nov;3(11):1196-8. doi: 10.1016/j.jcmg.2010.07.010. No abstract available.
• Avanzini A, Donzella G, Libretti L. Functional and structural effects of percutaneous edge-to-edge double-orifice repair under cardiac cycle in comparison with suture repair. Proc Inst Mech Eng H. 2011 Oct;225(10):959-71. doi: 10.1177/0954411911414803.
• Delgado V, Kapadia S, Marsan NA, Schalij MJ, Tuzcu EM, Bax JJ. Multimodality imaging before, during, and after percutaneous mitral valve repair. Heart. 2011 Oct;97(20):1704-14. doi: 10.1136/hrt.2011.227785. No abstract available.
• Ewe SH, Klautz RJ, Schalij MJ, Delgado V. Role of computed tomography imaging for transcatheter valvular repair/insertion. Int J Cardiovasc Imaging. 2011 Dec;27(8):1179-93. doi: 10.1007/s10554-011-9830-5. Epub 2011 Feb 26.
• Lin BA, Forouhar AS, Pahlevan NM, Anastassiou CA, Grayburn PA, Thomas JD, Gharib M. Color Doppler jet area overestimates regurgitant volume when multiple jets are present. J Am Soc Echocardiogr. 2010 Sep;23(9):993-1000. doi: 10.1016/j.echo.2010.06.011. Epub 2010 Aug 8.
• Pedrazzini GB, Klimusina J, Pasotti E, Moccetti T, Faletra FF. Complications of percutaneous edge-to-edge mitral valve repair: the role of real-time three-dimensional transesophageal echocardiography. J Am Soc Echocardiogr. 2011 Jun;24(6):706.e5-7. doi: 10.1016/j.echo.2010.08.017. Epub 2010 Sep 26.
• Siegel RJ, Luo H, Biner S. Transcatheter valve repair/implantation. Int J Cardiovasc Imaging. 2011 Dec;27(8):1165-77. doi: 10.1007/s10554-011-9833-2. Epub 2011 Feb 23.
• Yong ZY, Bouma BJ, Koch KT, Baan J. Immediate reduction of mitral regurgitation by percutaneous mitral valve repair with the MitraClip(R). Neth Heart J. 2010 Dec;18(12):606. doi: 10.1007/s12471-010-0843-9. No abstract available.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: February 4, 2011
• First Submitted That Met QC Criteria: February 21, 2011
• First Posted (ESTIMATE): February 23, 2011

Study Record Updates

• Last Update Posted (ACTUAL): November 7, 2018
• Last Update Submitted That Met QC Criteria: November 5, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: MitraClip; congestive heart failure; mitral valve insufficiency; percutaneous mitral valve repair; mitral regurgitation (MR)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: Protocol #M10-001