MitraClip REPAIR MR Study
- Conditions
- Mitral Valve Regurgitation
- Interventions
- Procedure: Mitral Valve Repair SurgeryDevice: MitraClip™ device implantation
- Registration Number
- NCT04198870
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
-
Subject has severe (Grade III or greater per the ASE criteria, which includes severity grades of 3+ and 4+) primary MR (mixed etiology is acceptable provided the principal mechanism of action is a degenerative mitral valve) as assessed by the ECL.
-
The cardiac surgeon of the Site Heart Team (consisting of at least one interventionalist, and one cardiac surgeon) has confirmed that the subject is a candidate for mitral valve surgery and the EC have confirmed that the subject's mitral valve anatomy is suitable for percutaneous repair with the MitraClip™ device with high certainty of achieving MR ≤ mild
-
Subject is symptomatic (NYHA Class II/III/IV) or asymptomatic with LVEF ≤ 60%, pulmonary artery systolic pressure > 50 mmHg, or LVESD > 40 mm
-
Subject is at moderate surgical risk defined as being at least 75 years of age at the time of EC review. If younger than 75 years, then the subject should have:
- Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) Repair Score ≥ 2%, OR
- Presence of other comorbidities which may introduce a potential surgery-specific impediment
-
Subject provides written informed consent
-
Subject is ≥ 18 years of age
- Subject is currently participating in another clinical investigation
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- Subject has ischemic or non-ischemic secondary MR
- Concomitant severe tricuspid valve regurgitation
- Ejection fraction <30%
- Severe mitral annular calcification
- Acute myocardial infarction in the past 12 weeks
- Need for cardiac surgery to correct pulmonary valve disease, aortic valve disease, or tricuspid valve disease
- Subjects who have concurrent coronary artery disease that needs to be treated may be included provided the subjects are eligible for both percutaneous coronary intervention (PCI) and coronary artery bypass surgery. Subjects randomized to the device group, must undergo PCI before the MitraClip™ device procedure. Subjects randomized to the surgical (control) arm may undergo coronary artery revascularization during mitral valve repair surgery
- Surgical procedure performed in the past 30 days
- Femoral vein cannot accommodate a 24 F catheter or presence of IVC filter would interfere with the catheter or ipsilateral DVT
- Transesophageal echocardiography (TEE) is contraindicated.
- Hemodynamic instability: systolic pressure ≤ 90 mmHg without afterload reduction, cardiogenic shock, or the need for inotropic support or IABP
- Need for emergency surgery for any reason
- Prior mitral valve surgery, valvuloplasty, mechanical prosthetic valve or VAD
- Systolic anterior motion of the mitral valve
- Hypertrophic cardiomyopathy
- Renal insufficiency requiring dialysis
- Active infections requiring current antibiotic therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Arm Mitral Valve Repair Surgery Mitral Valve Repair Surgery Device Arm MitraClip™ device implantation MitraClip™ device implantation
- Primary Outcome Measures
Name Time Method Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous) 2 Years Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous) from the time of index procedure through 2 years in the Device and Control groups, respectively
All-cause mortality, stroke, cardiac hospitalization, or acute kidney injury requiring renal replacement therapy at 2 years (any cardiac hospitalizations in the first 30 days post treatment will be excluded) 2 Years The proportion of subjects who are alive, without stroke, CV hospitalization or acute kidney injury requiring renal replacement therapy at 2 years in the Device and Control groups, respectively
- Secondary Outcome Measures
Name Time Method Number of days at hospital from index procedure to home discharge At Discharge (≤ 14 days following index procedure) Hospital length of stay from index procedure to home discharge (days) in Device group compared to the Control group
Proportion of subjects with MR ≤ mild at 30 days post index procedure among survivors 30 Days The proportion of subjects with MR ≤ mild at 30 days post index procedure among survivors will be compared between the Device and Control groups
Quality of life improvement assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) of at least 10 points at 2 years compared to baseline among survivors. 2 Years The proportion of subjects who have at least a 10 point improvement in KCCQ at 2 years post index procedure from baseline among survivors will be compared between the Device and Control groups for non-inferiority.
The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered questionnaire used for quantifying patient's health status including the symptoms (frequency and burden), physical and social limitations, and quality of life impact due to the heart failure syndrome. Validity, reproducibility, responsiveness and interpretability of the scores have been independently established for each of these health status domains, and overall summary scores are reported in a range of 0-100, in which higher scores reflect better health status.Proportion of subjects discharged to home post index hospitalization At Discharge (≤ 14 days following index procedure) The proportion of subjects who are discharged to home post index hospitalization will be compared between the Device and Control groups
Severe symptomatic mitral stenosis at 1 year 1 Year The proportion of subjects who have severe symptomatic mitral stenosis at 1 year post index procedure will be compared between the Device and Control groups
Trial Locations
- Locations (85)
Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Arizona Cardiovascular Research Center
🇺🇸Phoenix, Arizona, United States
University Hospital - Univiversity of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Cardiology Associates of Mobile, Inc.
🇺🇸Mobile, Alabama, United States
Banner-University Medical Center Phoenix
🇺🇸Phoenix, Arizona, United States
St. Josephs Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Tucson Medical Center
🇺🇸Tucson, Arizona, United States
Scripps Memorial Hospital La Jolla
🇺🇸La Jolla, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Sutter Medical Center, Sacramento
🇺🇸Sacramento, California, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
University of California at San Francisco
🇺🇸San Francisco, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Los Robles Regional Medical Center
🇺🇸Thousand Oaks, California, United States
Saint Joseph Hospital
🇺🇸Denver, Colorado, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Manatee Memorial Hospital
🇺🇸Bradenton, Florida, United States
Baptist Medical Center
🇺🇸Jacksonville, Florida, United States
NCH Healthcare System
🇺🇸Naples, Florida, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
WellStar Kennestone Hospital
🇺🇸Marietta, Georgia, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Prairie Education & Research Cooperative
🇺🇸Springfield, Illinois, United States
St. Vincent Hospital
🇺🇸Indianapolis, Indiana, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
Via Christi Regional Medical Center - St. Francis Campus
🇺🇸Wichita, Kansas, United States
Cardiovascular Research Institute of Kansas
🇺🇸Wichita, Kansas, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Beaumont Hospital, Royal Oak
🇺🇸Royal Oak, Michigan, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Atlantic Health System - Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States
Albany Medical Center
🇺🇸Albany, New York, United States
South Shore University Hospital
🇺🇸Bay Shore, New York, United States
Buffalo General Hospital
🇺🇸Buffalo, New York, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
New York-Presbyterian/Columbia University Medical Center
🇺🇸New York, New York, United States
Rochester Regional Health
🇺🇸Rochester, New York, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
Mission Health & Hospitals
🇺🇸Asheville, North Carolina, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Christ Hospital
🇺🇸Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Mt. Carmel East
🇺🇸Columbus, Ohio, United States
West Virginia University Hospital
🇺🇸Morgantown, West Virginia, United States
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Pinnacle Health System
🇺🇸Harrisburg, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Allegheny General Hospital - ASRI
🇺🇸PIttsburg, Pennsylvania, United States
Lankenau Institute for Medical Research
🇺🇸Wynnewood, Pennsylvania, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
St Thomas Hospital
🇺🇸Nashville, Tennessee, United States
Vanderbilt Heart & Vascular Institute
🇺🇸Nashville, Tennessee, United States
Ascension Texas Cardiovascular
🇺🇸Austin, Texas, United States
Austin Heart
🇺🇸Austin, Texas, United States
Park Plaza Hospital/HCA Hospital of Houston
🇺🇸Houston, Texas, United States
Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
The Heart Institute at Virginia Mason
🇺🇸Seattle, Washington, United States
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
🇨🇦Montréal, Quebec, Canada
Universitätsklinikum Ulm
🇩🇪Ulm, Bad-wur, Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
🇩🇪Frankfurt am Main, Hessen, Germany
Herz-und Diabetes Zentrum NRW
🇩🇪Bad Oeynhausen, North Rhine-Westphalia, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Rhinela, Germany
Herzzentrum Leipzig GmbH
🇩🇪Leipzig, Saxony, Germany
Deutsches Herzzentrum München des Freistaates Bayern
🇩🇪München, Germany
Universitätsklinikum Rostock (AöR)
🇩🇪Rostock, Germany
Center Inselspital Bern
🇨🇭Bern, Switzerland