Long Term Follow Up for CTSN Mitral Valve Repair Studies



Status:Enrolling by invitation
Conditions:Peripheral Vascular Disease, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/6/2019
Start Date:May 3, 2017
End Date:June 30, 2019

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Long-Term Follow-Up For Participants Of: Evaluation Of Outcomes Following Mitral Valve Repair/Replacement In SMR and Surgical Interventions For MMR Trials

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.

This study is a continuation of two CTSN randomized trials --- the Severe Ischemic Mitral
Regurgitation (SMR) Trial (NCT00807040) and the Moderate Ischemic Mitral regurgitation (MMR)
Trial (NCT00806988) --- for the purpose of assessing the long-term outcomes of the index
surgical therapies. Key clinical outcomes will be collected utilizing electronic medical
records, patient and/or family input, public records, and healthcare- and vital
status-related databases. Extended follow-up data will be obtained on up to 199 SMR and 270
MMR trial participants, who were alive at their 2-year follow-up evaluation. Patients will be
followed for a minimum of 5 years and up to 10 years after randomization (the time of index
surgical procedure). This follow-up data collection will be conducted by the Cardiothoracic
Surgical Trials Network (CTSN) primarily utilizing the minimal PHI necessary to link data
obtained from the MMR and SMR trials to other healthcare- and/or vital status-related
databases.

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.

Inclusion Criteria:

- Randomized patients in the MMR and SMR trials who were still alive at 2 years after
the index cardiac surgical intervention

Exclusion Criteria:

- Patients participating in the MMR and SMR trials who withdrew consent prior to the
2-year follow-up evaluation
We found this trial at
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8600 Old Georgetown Road
Bethesda, Maryland 20814
301-896-3100
Principal Investigator: Michael Siegenthaler, MD
Phone: 301-896-3775
Suburban Hospital Suburban Hospital is a community-based, not-for-profit hospital serving Montgomery County and the surrounding...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Vinod Thourani, MD
Phone: 404-686-3374
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Sary Aranki, MD
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Peter Smith, MD
Phone: 919-681-2172
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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Los Angeles, California 90033
213) 740-2311
Principal Investigator: Michael Bowdish, Md
Phone: 323-409-5573
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, CA
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Asheville, North Carolina 28801
Principal Investigator: Mark A Groh, MD
Phone: 828-213-5673
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Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: James S Gammie, MD
Phone: 410-328-9409
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Baltimore, MD
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Bronx, New York 10467
Principal Investigator: Robert Michler, MD
Phone: 718-920-6742
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Charlottesville, Virginia 22908
Principal Investigator: Irving L Kron, MD
Phone: 434-243-0315
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: A. Marc Gillinov, MD
Phone: (216) 445-1647
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Bryan Whitson, Whitson
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Edmonton, Alberta
Principal Investigator: John C Mullen, MD, MSc
Phone: 780-407-6327
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Falls Church, Virginia 22042
Principal Investigator: Alan M Speir, MD
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Greenville, North Carolina 27834
Principal Investigator: Shahab Akhter, MD
Phone: 252-744-8482
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Michael Argenziano, MD
Phone: 212-342-0261
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Michael A Acker, MD
Phone: 215-662-7981
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Plano, Texas 75093
Principal Investigator: Michael Mack, MD
Phone: 972-566-4083
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