NCT02675244|CompletedResultsDMC
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Sponsor study identifier
Secondary identifiers
interventional
401
3 countries
41
Study Start
May 26, 2016
Actual (reported)Primary Completion
April 19, 2021
Actual (reported)Study Completion
April 19, 2021
Actual (reported)The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve surgery (MVS), would improve the heart health of those who receive it compared to those who do not. At this point, the medical community is split in their opinion on whether surgeons should routinely repair mild to moderate TR in patients who are undergoing planned mitral valve surgery, and this study will answer this question.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 19, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 29, 2016
Actual (reported)February 5, 2016
Actual (reported)May 26, 2016
Actual (reported)April 19, 2021
Actual (reported)April 19, 2021
Actual (reported)September 21, 2023
Actual (reported)Percentage of Participants With Treatment Failure
The primary outcome of this trial is treatment failure defined as the composite of (1) death from any cause, (2) reoperation for TR, (3) presence of severe TR at two years post randomization or, for patients enrolled with less than moderate TR and annular dilatation, progression by two grades (i.e., from none/trace TR to moderate TR) at two years post randomization.
24 Months
Number of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE)
up to 24 Months
Number of Participants With NYHA Classification I-IV
at 24 Months
Diuretic Use
24 Months
Six Minute Walk Test
24 Months
Number of Participants With Degree of TR
up to 24 Months
Participants will undergo mitral valve surgery alone.
Patients will undergo mitral valve surgery and tricuspid valve annuloplasty.
TV Annuloplasty will be performed using standard surgical techniques
MVS will be performed using standard surgical techniques
University of Southern California
Los Angeles, California, 90033, United States
Stanford University School of Medicine
Stanford, California, 94305, United States
Yale University School of Medicine - Yale-New Haven Hospital
New Haven, Connecticut, 06520-8039, United States
Emory University
Atlanta, Georgia, 30308, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Suburban Hospital
Bethesda, Maryland, 20814, United States
MedStar Health
Columbia, Maryland, 21044, United States
Chu MWA, Raymond S, Gelijns AC, Moskowitz AJ, Borger MA, Mack M, Hung J, Voisine P, Gammie JS, Krane M, Yerokun BA, Bowdish ME, Conradi L, Bolling SF, Taddei-Peters WC, Jeffries NO, Marks ME, Gupta L, Iribarne A, Beyersdorf F, Bagiella E, Geirsson A, Overbey JR, Gillinov M, O'Gara PT, Ailawadi G, Falk V. Mitral Valve Repair for Degenerative MR With Moderate or Less Tricuspid Regurgitation: 2-Year Outcomes From a Multicenter Echocardiographic Core Laboratory-Adjudicated Cohort. J Am Coll Cardiol. 2026 Jun 23;87(24):3436-3448. doi: 10.1016/j.jacc.2025.12.065. Epub 2026 Feb 18.
Ailawadi G, Voisine P, Raymond S, Gelijns AC, Moskowitz AJ, Falk V, Overbey JR, Chu MWA, Mack MJ, Bowdish ME, Krane M, Yerokun B, Conradi L, Bolling SF, Miller MA, Taddei-Peters WC, Fenton KN, Jeffries NO, Kramer RS, Geirsson A, Moquete EG, O'Sullivan K, Hupf J, Hung J, Beyersdorf F, Bagiella E, Gammie JS, O'Gara PT, Iribarne A, Borger MA, Gillinov M; trial investigators. Pacemaker implantation associated with tricuspid repair in the setting of mitral valve surgery: Insights from a Cardiothoracic Surgical Trials Network randomized trial. J Thorac Cardiovasc Surg. 2024 Jun;167(6):2104-2116.e5. doi: 10.1016/j.jtcvs.2022.11.031. Epub 2022 Dec 8.
Annetine C. Gelijns, PhD
Icahn School of Medicine at Mount Sinai
Richard Weisel, MD
Toronto General Hospital
401 participants (actual enrollment reported by the registry).
First Submitted
January 29, 2016
First Posted
February 5, 2016
Study Start
May 26, 2016
Actual (reported)Tricuspid Cardiopulmonary Exercise Study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
University of Michigan Health Services
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766, United States
Columbia University Medical Center
New York, New York, 10032, United States
Stony Brook Hospital
Stony Brook, New York, 11790, 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
WakeMed Clinical Research Institute
Raleigh, North Carolina, 27610, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Baylor College of Medicine
Houston, Texas, United States
Baylor Research Institute
Plano, Texas, 75093, United States
University of Virginia Health Systems
Charlottesville, Virginia, 22908, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
University of Alberta Hospital
Edmonton, Alberta, T6G2B7, Canada
London Health Sciences
London, Ontario, N6A 5A5, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, 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, H4J 1C5, Canada
Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
Québec, Quebec, G1V 4G5, Canada
Universitares Herzzentrum Hamburg
Berlin, Brandenburg, 11353, Germany
Herzzentrum Leipzig
Berlin, Brandenburg, 13347, Germany
University Hospital Frankfurt
Frankfurt, Hesse-Nassau, 60590, Germany
University Medical Center Göttingen
Göttingen, Lower Saxony, Germany
University Medical Center Jena
Jena, Thuringia, Germany
HDZ NRW Bad Oeynhausen
Bad Oeynhausen, Germany
Deutsches Herzzentrum Berlin
Berlin, Germany
Heart Center, University of Freiburg
Freiburg im Breisgau, Germany
German Heart Center Munich
Munich, Germany
Gammie JS, Chu MWA, Falk V, Overbey JR, Moskowitz AJ, Gillinov M, Mack MJ, Voisine P, Krane M, Yerokun B, Bowdish ME, Conradi L, Bolling SF, Miller MA, Taddei-Peters WC, Jeffries NO, Parides MK, Weisel R, Jessup M, Rose EA, Mullen JC, Raymond S, Moquete EG, O'Sullivan K, Marks ME, Iribarne A, Beyersdorf F, Borger MA, Geirsson A, Bagiella E, Hung J, Gelijns AC, O'Gara PT, Ailawadi G; CTSN Investigators. Concomitant Tricuspid Repair in Patients with Degenerative Mitral Regurgitation. N Engl J Med. 2022 Jan 27;386(4):327-339. doi: 10.1056/NEJMoa2115961. Epub 2021 Nov 13.
Primary Completion
April 19, 2021
Actual (reported)Study Completion
April 19, 2021
Actual (reported)Last Updated
June 18, 2024
Results First Posted
September 21, 2023
Record last verified: 2024-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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