ACTIVE_NOT_RECRUITING

MitraClip REPAIR MR Study

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Conditions

Mitral Valve RegurgitationMitraClip

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Percutaneous MitraClip Device or Surgical Mitral Valve REpair in PAtients With PrImaRy MItral Regurgitation Who Are Candidates for Surgery (REPAIR MR)

Quick Facts

Study Start:2020-07-21
Study Completion:2035-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04198870

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 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.
  2. 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. 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. 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:
  5. 1. Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) Repair Score ≥ 2%, OR
  6. 2. Presence of other comorbidities which may introduce a potential surgery-specific impediment
  7. 5. Subject provides written informed consent
  8. 6. Subject is ≥ 18 years of age
  1. 1. Subject is currently participating in another clinical investigation
  2. 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. 3. Subject has ischemic or non-ischemic secondary MR
  4. 4. Concomitant severe tricuspid valve regurgitation
  5. 5. Ejection fraction \<30%
  6. 6. Severe mitral annular calcification
  7. 7. Acute myocardial infarction in the past 12 weeks
  8. 8. Need for cardiac surgery to correct pulmonary valve disease, aortic valve disease, or tricuspid valve disease
  9. 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. 10. Surgical procedure performed in the past 30 days
  11. 11. Femoral vein cannot accommodate a 24 F catheter or presence of IVC filter would interfere with the catheter or ipsilateral DVT
  12. 12. Transesophageal echocardiography (TEE) is contraindicated.
  13. 13. Hemodynamic instability: systolic pressure ≤ 90 mmHg without afterload reduction, cardiogenic shock, or the need for inotropic support or IABP
  14. 14. Need for emergency surgery for any reason
  15. 15. Prior mitral valve surgery, valvuloplasty, mechanical prosthetic valve or VAD
  16. 16. Systolic anterior motion of the mitral valve
  17. 17. Hypertrophic cardiomyopathy
  18. 18. Renal insufficiency requiring dialysis
  19. 19. Active infections requiring current antibiotic therapy

Contacts and Locations

Principal Investigator

Patrick McCarthy, MD
PRINCIPAL_INVESTIGATOR
Northwestern Memorial Hospital
Saibal Kar, MD
PRINCIPAL_INVESTIGATOR
Los Robles Regional Medical Center

Study Locations (Sites)

University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35249
United States
Cardiology Associates of Mobile, Inc.
Mobile, Alabama, 36608
United States
Banner-University Medical Center Phoenix
Phoenix, Arizona, 85006
United States
St. Josephs Hospital and Medical Center
Phoenix, Arizona, 85013
United States
Arizona Cardiovascular Research Center
Phoenix, Arizona, 85016
United States
Tucson Medical Center
Tucson, Arizona, 85712
United States
Scripps Health
La Jolla, California, 92037
United States
Sutter Medical Center, Sacramento
Sacramento, California, 95816
United States
University of California - Davis Medical Center
Sacramento, California, 95817
United States
Mercy General Hospital
Sacramento, California, 95819
United States
University of California at San Francisco
San Francisco, California, 94143
United States
Stanford University Medical Center
Stanford, California, 94305
United States
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
United States
Saint Joseph Hospital
Denver, Colorado, 80218
United States
Yale New Haven Hospital
New Haven, Connecticut, 06510
United States
Baptist Medical Center
Jacksonville, Florida, 32207
United States
NCH Healthcare System
Naples, Florida, 34102
United States
Piedmont Heart Institute
Atlanta, Georgia, 30309
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
Prairie Education & Research Cooperative
Springfield, Illinois, 62701
United States
Ascension St. Vincent
Indianapolis, Indiana, 46240
United States
Kansas University Medical Center
Kansas City, Kansas, 66160
United States
Via Christi Regional Medical Center - St. Francis Campus
Wichita, Kansas, 67214
United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas, 67226
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
University of Michigan Medical Center
Ann Arbor, Michigan, 48104
United States
Henry Ford Health
Detroit, Michigan, 48202
United States
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, 48073
United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
United States
Cooper University Hospital
Camden, New Jersey, 08103
United States
Morristown Medical Center
Morristown, New Jersey, 07962
United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
United States
Albany Medical Center
Albany, New York, 12208
United States
South Shore University Hospital
Bay Shore, New York, 11706
United States
NYU Langone Health
New York, New York, 10016
United States
New York-Presbyterian/Columbia University Medical Center
New York, New York, 10032
United States
Rochester Regional Health
Rochester, New York, 14617
United States
St. Francis Hospital
Roslyn, New York, 11576
United States
Mission Health & Hospitals
Asheville, North Carolina, 28801
United States
Carolinas Medical Center
Charlotte, North Carolina, 28203
United States
Duke University Medical Center
Durham, North Carolina, 27705
United States
Christ Hospital
Cincinnati, Ohio, 45219
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Mt. Carmel East
Columbus, Ohio, 43213
United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112
United States
Pinnacle Health Cardiovascular Institute, Inc.
Harrisburg, Pennsylvania, 17105
United States
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania, 15212
United States
UPMC
Pittsburgh, Pennsylvania, 15213
United States
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096
United States
TriStar Centennial Medical Center
Nashville, Tennessee, 37203
United States
Ascension Saint Thomas
Nashville, Tennessee, 37205
United States
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee, 37232
United States
Ascension Texas Cardiovascular Research
Austin, Texas, 78705
United States
HCA Houston Healthcare Medical Center
Houston, Texas, 77004
United States
UTHealth Memorial Hermann
Houston, Texas, 77008
United States
Houston Methodist
Houston, Texas, 77030
United States
Intermountain Medical Center
Murray, Utah, 84157
United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908
United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
United States
Swedish Medical Center
Seattle, Washington, 98107
United States
The Heart Institute at Virginia Mason
Seattle, Washington, 98111
United States
West Virginia University Hospital
Morgantown, West Virginia, 26506
United States

Collaborators and Investigators

Sponsor: Abbott Medical Devices

  • Patrick McCarthy, MD, PRINCIPAL_INVESTIGATOR, Northwestern Memorial Hospital
  • Saibal Kar, MD, PRINCIPAL_INVESTIGATOR, Los Robles Regional Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-21
Study Completion Date2035-12

Study Record Updates

Study Start Date2020-07-21
Study Completion Date2035-12

Terms related to this study

Keywords Provided by Researchers

  • MitraClip

Additional Relevant MeSH Terms

  • Mitral Valve Regurgitation