Long Term Follow Up for CTSN Mitral Valve Repair Studies
NCT ID: NCT03066050
Last Updated: 2025-07-16
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
368 participants
OBSERVATIONAL
2017-05-03
2027-07-31
Brief Summary
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Detailed Description
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Because the design of surgical trials for ischemic mitral regurgitation that would use mortality as a primary endpoint requires the enrollment of thousands of patients, the selected primary endpoint for the CTSN SMR and MMR trials was an echocardiographic measure of left ventricular remodeling. Secondary endpoints included, among others, survival, adverse events, readmissions and costs over a 2-year period. The SMR trial showed no difference in left ventricular reverse remodeling, but the rate of moderate or severe mitral regurgitation recurrence was significantly higher with mitral valve repair, resulting in more heart failure-related adverse events and cardiovascular admissions. Longer-term follow-up will be critical to assess whether this observed trend amongst SMR patients will continue and whether a survival difference will manifest over time. In moderate ischemic mitral regurgitation, mitral valve repair provided a more durable correction of mitral regurgitation than coronary artery bypass grafting (CABG) alone, but repair did not improve survival or reduce overall adverse events or readmissions, and was associated with an early hazard of neurological and supraventricular arrhythmic events. Longer-term follow-up of MMR patients will provide insights into whether the higher degree of recurrent mitral regurgitation with CABG alone will be associated with differences in adverse events, readmissions and survival. Additionally, the benefits of alternative surgical treatments for ischemic mitral regurgitation, which have differential upfront risks and costs, will likely extend beyond 2 years. Cost-effectiveness analysis will delineate the long-term cost-benefit trade-offs between mitral valve repair versus replacement for SMR, and of CABG with repair versus CABG alone for MMR, which should inform surgical decision making, and examine how differences in life expectancy and risk profiles of different patient groups affect cost-effectiveness over time. This extended follow-up should provide important clinical and health policy insights.
Conditions
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Study Design
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OTHER
OTHER
Study Groups
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SMR MV Repair
This group of patients had been randomized in the SMR study to mitral valve repair with annuloplasty ring.
MV Repair
Participants underwent mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
MV Replacement
This group of patients had been randomized in the SMR study to mitral valve replacement.
MV Replacement
Participants underwent mitral valve replacement and complete preservation of the sub-valvular apparatus.
MMR MV Repair
This group of patients had been randomized in the MMR study to mitral valve repair with annuloplasty ring.
MV Repair
Participants underwent mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
CABG
This group of patients had been randomized in the MMR study to receive CABG
CABG
Participants underwent coronary artery bypass grafting
Interventions
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MV Repair
Participants underwent mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
MV Replacement
Participants underwent mitral valve replacement and complete preservation of the sub-valvular apparatus.
CABG
Participants underwent coronary artery bypass grafting
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Annetine Gelijns
Professor
Principal Investigators
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Annetine C Gelijns, PhD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Richard Weisel, MD
Role: STUDY_CHAIR
Toronto General Hospital
Locations
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University of Southern California
Los Angeles, California, United States
Emory University
Atlanta, Georgia, United States
University of Maryland
Baltimore, Maryland, United States
Suburban Hospital
Bethesda, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Columbia University Medical Center
New York, New York, United States
Montefiore Einstein Heart Center
The Bronx, New York, United States
Mission Hospital
Asheville, North Carolina, United States
Duke University
Durham, North Carolina, United States
East Carolina Heart Institute
Greenville, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Baylor Research Institute
Plano, Texas, United States
University of Virginia Health Systems
Charlottesville, Virginia, United States
Inova Heart and Vascular Institute
Falls Church, Virginia, United States
University of Alberta Hospital
Edmonton, Alberta, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
Saint Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
Québec, , Canada
Countries
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Other Identifiers
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GCO 08-1078-00012
Identifier Type: -
Identifier Source: org_study_id
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