Phase
Condition
Mitral Valve Regurgitation
Treatment
MitraClip™ device implantation
Mitral Valve Repair Surgery
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject has severe (Grade III or greater per the ASE criteria, which includesseverity grades of 3+ and 4+) primary MR (mixed etiology is acceptable provided theprincipal mechanism of action is a degenerative mitral valve) as assessed by theECL.
The cardiac surgeon of the Site Heart Team (consisting of at least oneinterventionalist, and one cardiac surgeon) has confirmed that the subject is acandidate for mitral valve surgery and the EC have confirmed that the subject'smitral valve anatomy is suitable for percutaneous repair with the MitraClip™ devicewith 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 atthe time of EC review. If younger than 75 years, then the subject should have:
Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) RepairScore ≥ 2%, OR
Presence of other comorbidities which may introduce a potentialsurgery-specific impediment
Subject provides written informed consent
Subject is ≥ 18 years of age
Exclusion
Exclusion Criteria:
Subject is currently participating in another clinical investigation
Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements, or impact the scientific soundness of the clinicalinvestigation 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 beincluded provided the subjects are eligible for both percutaneous coronaryintervention (PCI) and coronary artery bypass surgery. Subjects randomized to thedevice group, must undergo PCI before the MitraClip™ device procedure. Subjectsrandomized to the surgical (control) arm may undergo coronary arteryrevascularization 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 wouldinterfere 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
Connect with a study center
Ottawa Heart Institute
Ottawa, Ontario K1Y 4W7
CanadaSite Not Available
St. Michael's Hospital
Toronto, Ontario M5B 1W8
CanadaActive - Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario M5N 3M5
CanadaActive - Recruiting
Toronto General Hospital
Toronto, Ontario M5G 2C4
CanadaActive - Recruiting
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montréal, Quebec H1T 1C8
CanadaActive - Recruiting
Universitätsklinikum Ulm
Ulm, Bad-wur 89081
GermanyActive - Recruiting
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt am Main, Hessen 60590
GermanyActive - Recruiting
Herz-und Diabetes Zentrum NRW
Bad Oeynhausen, North Rhine-Westphalia 32545
GermanyActive - Recruiting
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Rhinela 55131
GermanyActive - Recruiting
Herzzentrum Leipzig GmbH
Leipzig, Saxony 04289
GermanySite Not Available
Deutsches Herzzentrum München des Freistaates Bayern
München, 80636
GermanyActive - Recruiting
Universitätsklinikum Rostock (AöR)
Rostock, 18057
GermanyActive - Recruiting
Ospedale San Raffaele - Cardiac
Milano, Lombard 20132
ItalySite Not Available
Policlinico San Donato
San Donato Milanese, Lombard 20097
ItalySite Not Available
Center Inselspital Bern
Bern, 3010
SwitzerlandActive - Recruiting
University Hospital - Univiversity of Alabama at Birmingham
Birmingham, Alabama 35249
United StatesActive - Recruiting
Cardiology Associates of Mobile, Inc.
Mobile, Alabama 36608
United StatesActive - Recruiting
Arizona Cardiovascular Research Center
Phoenix, Arizona 85016
United StatesTerminated
Banner-University Medical Center Phoenix
Phoenix, Arizona 85006
United StatesActive - Recruiting
St. Joseph's Hospital & Medical Center
Phoenix, Arizona 85013
United StatesSite Not Available
St. Josephs Hospital and Medical Center
Phoenix, Arizona 85013
United StatesActive - Recruiting
Tucson Medical Center
Tucson, Arizona 85712
United StatesActive - Recruiting
Scripps Memorial Hospital La Jolla
La Jolla, California 92037
United StatesActive - Recruiting
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
Mercy General Hospital
Sacramento, California 95819
United StatesActive - Recruiting
Sutter Medical Center, Sacramento
Sacramento, California 95816
United StatesActive - Recruiting
UC Davis Medical Center
Sacramento, California 95817
United StatesActive - Recruiting
University of California at San Francisco
San Francisco, California 94143
United StatesActive - Recruiting
Stanford University Medical Center
Stanford, California 94305
United StatesActive - Recruiting
Los Robles Regional Medical Center
Thousand Oaks, California 91360
United StatesActive - Recruiting
Saint Joseph Hospital
Denver, Colorado 80218
United StatesActive - Recruiting
Yale New Haven Hospital
New Haven, Connecticut 06510
United StatesActive - Recruiting
Manatee Memorial Hospital
Bradenton, Florida 34208
United StatesSite Not Available
Baptist Medical Center
Jacksonville, Florida 32207
United StatesActive - Recruiting
NCH Healthcare System
Naples, Florida 34102
United StatesActive - Recruiting
AdventHealth Orlando
Orlando, Florida 33019
United StatesSite Not Available
Piedmont Heart Institute
Atlanta, Georgia 30309
United StatesActive - Recruiting
WellStar Kennestone Hospital
Marietta, Georgia 30060
United StatesSite Not Available
Northwestern Memorial Hospital
Chicago, Illinois 60611
United StatesActive - Recruiting
Prairie Education & Research Cooperative
Springfield, Illinois 62701
United StatesActive - Recruiting
St. Vincent Hospital
Indianapolis, Indiana 46240
United StatesActive - Recruiting
Kansas University Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
Cardiovascular Research Institute of Kansas
Wichita, Kansas 67226
United StatesActive - Recruiting
Via Christi Regional Medical Center - St. Francis Campus
Wichita, Kansas 67214
United StatesActive - Recruiting
Brigham & Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
University of Michigan
Ann Arbor, Michigan 48104
United StatesActive - Recruiting
Henry Ford Hospital
Detroit, Michigan 48202
United StatesActive - Recruiting
Beaumont Hospital, Royal Oak
Royal Oak, Michigan 48073
United StatesActive - Recruiting
Abbott Northwestern Hospital
Minneapolis, Minnesota 55407
United StatesActive - Recruiting
Cooper University Hospital
Camden, New Jersey 08103
United StatesActive - Recruiting
Atlantic Health System - Morristown Memorial Hospital
Morristown, New Jersey 07962
United StatesActive - Recruiting
Jersey Shore University Medical Center
Neptune, New Jersey 07753
United StatesActive - Recruiting
Robert Wood Johnson University Hospital
New Brunswick, New Jersey 08901
United StatesSite Not Available
Albany Medical Center
Albany, New York 12208
United StatesActive - Recruiting
South Shore University Hospital
Bay Shore, New York 11706
United StatesActive - Recruiting
Southside Hospital - Northwell Health
Bay Shore, New York 11706
United StatesSite Not Available
Buffalo General Hospital
Buffalo, New York 14203
United StatesSite Not Available
NYU Langone Medical Center
New York, New York 10016
United StatesActive - Recruiting
New York-Presbyterian/Columbia University Medical Center
New York, New York 10032
United StatesActive - Recruiting
Rochester Regional Health
Rochester, New York 14617
United StatesActive - Recruiting
St. Francis Hospital
Roslyn, New York 11576
United StatesActive - Recruiting
Mission Health & Hospitals
Asheville, North Carolina 28801
United StatesActive - Recruiting
Carolinas Medical Center
Charlotte, North Carolina 28203
United StatesActive - Recruiting
Duke University Medical Center
Durham, North Carolina 27705
United StatesActive - Recruiting
Christ Hospital
Cincinnati, Ohio 45219
United StatesActive - Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
Mt. Carmel East
Columbus, Ohio 43213
United StatesActive - Recruiting
Integris Baptist Medical Center
Oklahoma City, Oklahoma 73112
United StatesActive - Recruiting
Pinnacle Health System
Harrisburg, Pennsylvania 17105
United StatesActive - Recruiting
Allegheny General Hospital - ASRI
PIttsburg, Pennsylvania 15212
United StatesActive - Recruiting
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania 15212
United StatesActive - Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania 19096
United StatesActive - Recruiting
Centennial Medical Center
Nashville, Tennessee 37203
United StatesActive - Recruiting
St Thomas Hospital
Nashville, Tennessee 37205
United StatesActive - Recruiting
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee 37232
United StatesActive - Recruiting
Ascension Texas Cardiovascular
Austin, Texas 78705
United StatesActive - Recruiting
Austin Heart
Austin, Texas 78756
United StatesSite Not Available
Memorial Hermann Hospital
Houston, Texas 77008
United StatesActive - Recruiting
Park Plaza Hospital/HCA Hospital of Houston
Houston, Texas 77004
United StatesActive - Recruiting
The Methodist Hospital
Houston, Texas 77030
United StatesActive - Recruiting
The Heart Hospital Baylor Plano
Plano, Texas 75093
United StatesSite Not Available
Intermountain Medical Center
Murray, Utah 84157
United StatesActive - Recruiting
University of Virginia Medical Center
Charlottesville, Virginia 22908
United StatesActive - Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United StatesActive - Recruiting
Swedish Medical Center
Seattle, Washington 98107
United StatesActive - Recruiting
The Heart Institute at Virginia Mason
Seattle, Washington 98111
United StatesActive - Recruiting
West Virginia University Hospital
Morgantown, West Virginia 26506
United StatesSite Not Available
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