Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
500 participants
INTERVENTIONAL
2020-07-21
2035-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control Arm
Mitral Valve Repair Surgery
Mitral Valve Repair Surgery
Surgical repair of the mitral valve
Device Arm
MitraClip™ device implantation
MitraClip™ device implantation
Transcatheter repair of the mitral valve using MitraClip™ device
Interventions
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MitraClip™ device implantation
Transcatheter repair of the mitral valve using MitraClip™ device
Mitral Valve Repair Surgery
Surgical repair of the mitral valve
Eligibility Criteria
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Inclusion Criteria
2. 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
3. Subject is symptomatic (NYHA Class II/III/IV) or asymptomatic with LVEF ≤ 60%, pulmonary artery systolic pressure \> 50 mmHg, or LVESD \> 40 mm
4. 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:
1. Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) Repair Score ≥ 2%, OR
2. Presence of other comorbidities which may introduce a potential surgery-specific impediment
5. Subject provides written informed consent
6. Subject is ≥ 18 years of age
Exclusion Criteria
2. 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.
3. Subject has ischemic or non-ischemic secondary MR
4. Concomitant severe tricuspid valve regurgitation
5. Ejection fraction \<30%
6. Severe mitral annular calcification
7. Acute myocardial infarction in the past 12 weeks
8. Need for cardiac surgery to correct pulmonary valve disease, aortic valve disease, or tricuspid valve disease
9. 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
10. Surgical procedure performed in the past 30 days
11. Femoral vein cannot accommodate a 24 F catheter or presence of IVC filter would interfere with the catheter or ipsilateral DVT
12. Transesophageal echocardiography (TEE) is contraindicated.
13. Hemodynamic instability: systolic pressure ≤ 90 mmHg without afterload reduction, cardiogenic shock, or the need for inotropic support or IABP
14. Need for emergency surgery for any reason
15. Prior mitral valve surgery, valvuloplasty, mechanical prosthetic valve or VAD
16. Systolic anterior motion of the mitral valve
17. Hypertrophic cardiomyopathy
18. Renal insufficiency requiring dialysis
19. Active infections requiring current antibiotic therapy
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Patrick McCarthy, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern Memorial Hospital
Saibal Kar, MD
Role: PRINCIPAL_INVESTIGATOR
Los Robles Regional Medical Center
Locations
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University Hospital - Univ. of Alabama at Birmingham (UAB)
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
Arizona Cardiovascular Research Center
Phoenix, Arizona, United States
Tucson Medical Center
Tucson, Arizona, United States
Scripps Health
La Jolla, California, United States
Sutter Medical Center, Sacramento
Sacramento, California, United States
University of California - 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
Baptist Medical Center
Jacksonville, Florida, United States
NCH Healthcare System
Naples, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Prairie Education & Research Cooperative
Springfield, Illinois, United States
Ascension St. Vincent
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 and Women's Hospital
Boston, Massachusetts, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Henry Ford Health
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
Morristown Medical Center
Morristown, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Albany Medical Center
Albany, New York, United States
South Shore University Hospital
Bay Shore, New York, United States
NYU Langone Health
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
Mt. Carmel East
Columbus, Ohio, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
Pinnacle Health Cardiovascular Institute, Inc.
Harrisburg, Pennsylvania, United States
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania, United States
UPMC
Pittsburgh, Pennsylvania, United States
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States
TriStar Centennial Medical Center
Nashville, Tennessee, United States
Ascension Saint Thomas
Nashville, Tennessee, United States
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee, United States
Ascension Texas Cardiovascular Research
Austin, Texas, United States
HCA Houston Healthcare Medical Center
Houston, Texas, United States
UTHealth Memorial Hermann
Houston, Texas, United States
Houston Methodist
Houston, 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
West Virginia University Hospital
Morgantown, West Virginia, 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.)
Montreal, Quebec, Canada
Universitätsklinikum Ulm
Ulm, Bad-wur, Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt am Main, Hesse, Germany
Herz-und Diabetes Zentrum NRW
Bad Oeynhausen, North Rhine-Westphalia, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Rhinela, Germany
Deutsches Herzzentrum München des Freistaates Bayern
München, , Germany
Universitätsklinikum Rostock (AöR)
Rostock, , Germany
Center Inselspital Bern
Bern, Canton of Bern, Switzerland
Countries
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References
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McCarthy PM, Whisenant B, Asgar AW, Ailawadi G, Hermiller J, Williams M, Morse A, Rinaldi M, Grayburn P, Thomas JD, Martin R, Asch FM, Shu Y, Sundareswaran K, Moat N, Kar S. Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation Who Are Candidates for Surgery: Design and Rationale of the REPAIR MR Trial. J Am Heart Assoc. 2023 Feb 21;12(4):e027504. doi: 10.1161/JAHA.122.027504. Epub 2023 Feb 8.
Kaneko T, Hirji S, Zaid S, Lange R, Kempfert J, Conradi L, Hagl C, Borger MA, Taramasso M, Nguyen TC, Ailawadi G, Shah AS, Smith RL, Anselmi A, Romano MA, Ben Ali W, Ramlawi B, Grubb KJ, Robinson NB, Pirelli L, Chu MWA, Andreas M, Obadia JF, Gennari M, Garatti A, Tchetche D, Nazif TM, Bapat VN, Modine T, Denti P, Tang GHL; CUTTING-EDGE Investigators. Mitral Valve Surgery After Transcatheter Edge-to-Edge Repair: Mid-Term Outcomes From the CUTTING-EDGE International Registry. JACC Cardiovasc Interv. 2021 Sep 27;14(18):2010-2021. doi: 10.1016/j.jcin.2021.07.029.
Other Identifiers
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ABT-CIP-10304
Identifier Type: -
Identifier Source: org_study_id