Long Term Follow Up for CTSN Mitral Valve Repair Studies
Long-Term Follow-Up For Participants Of: Evaluation Of Outcomes Following Mitral Valve Repair/Replacement In SMR and Surgical Interventions For MMR Trials
2 other identifiers
observational
368
2 countries
24
Brief Summary
This study is a continuation of two previous studies --- the Severe Ischemic Mitral Regurgitation (SMR) Trial (NCT00807040) and the Moderate Ischemic Mitral regurgitation (MMR) Trial (NCT00806988) --- to learn more about patients' health 5-10 years after their mitral valve surgeries. The investigators will collect long-term health information on SMR and MMR trial participants using electronic medical records, patient and/or family input, public records, and healthcare- and vital status-related databases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2017
Longer than P75 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2017
CompletedFirst Posted
Study publicly available on registry
February 28, 2017
CompletedStudy Start
First participant enrolled
May 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
July 16, 2025
July 1, 2025
10.2 years
February 2, 2017
July 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival
All-cause mortality will be assessed.
up to 10 years post-surgery (at the time of registry data transfer)
Secondary Outcomes (3)
Repeat Cardiac Interventions for MR
up to 10 years post-surgery (at the time of registry data transfer)
Hospital Costs
up to 10 years post-surgery (at the time of registry data transfer)
Cost Effectiveness
up to 10 years post-surgery (at the time of registry data transfer)
Study Arms (4)
SMR MV Repair
This group of patients had been randomized in the SMR study to mitral valve repair with annuloplasty ring.
MV Replacement
This group of patients had been randomized in the SMR study to mitral valve replacement.
MMR MV Repair
This group of patients had been randomized in the MMR study to mitral valve repair with annuloplasty ring.
CABG
This group of patients had been randomized in the MMR study to receive CABG
Interventions
Participants underwent mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
Participants underwent mitral valve replacement and complete preservation of the sub-valvular apparatus.
Participants underwent coronary artery bypass grafting
Eligibility Criteria
Randomized patients in the MMR and SMR trials who were still alive at 2 years after the index cardiac surgical intervention
You may qualify if:
- Randomized patients in the MMR and SMR trials who were still alive at 2 years after the index cardiac surgical intervention
You may not qualify if:
- Patients participating in the MMR and SMR trials who withdrew consent prior to the 2-year follow-up evaluation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
University of Southern California
Los Angeles, California, 90033, United States
Emory University
Atlanta, Georgia, 30308, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Suburban Hospital
Bethesda, Maryland, 20814, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Columbia University Medical Center
New York, New York, 10032, United States
Montefiore Einstein Heart Center
The Bronx, New York, 10467, United States
Mission Hospital
Asheville, North Carolina, 28801, United States
Duke University
Durham, North Carolina, 27710, United States
East Carolina Heart Institute
Greenville, North Carolina, 27834, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Baylor Research Institute
Plano, Texas, 75093, United States
University of Virginia Health Systems
Charlottesville, Virginia, 22908, United States
Inova Heart and Vascular Institute
Falls Church, Virginia, 22042, United States
University of Alberta Hospital
Edmonton, Alberta, T6G2B7, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, M4N 3M5, Canada
Saint Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Toronto General Hospital
Toronto, Ontario, M5B 1W8, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2W 1T8, Canada
Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
Québec, G1V 4G5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Annetine C Gelijns, PhD
Icahn School of Medicine at Mount Sinai
- STUDY CHAIR
Richard Weisel, MD
Toronto General Hospital
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 2, 2017
First Posted
February 28, 2017
Study Start
May 3, 2017
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
July 16, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share