Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

NCT02675244 | Completed Results DMC

• 2 other identifiers: GCO 08-1078-00102U01HL088942-07
• Study Type: interventional
• Target: 401
• Locations: 3 countries
• Sites: 41

Brief Summary

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.

Conditions

Mild Tricuspid Regurgitation; Moderate Tricuspid Regurgitation; Tricuspid Regurgitation

Keywords

Tricuspid Valve Regurgitation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (22)

• 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

Study Arms (2)

MVS Alone

ACTIVE COMPARATOR

Participants will undergo mitral valve surgery alone.

Procedure: MVS

MVS + TV Annuloplasty

ACTIVE COMPARATOR

Patients will undergo mitral valve surgery and tricuspid valve annuloplasty.

Procedure: TV Annuloplasty; Procedure: MVS

Interventions

TV Annuloplasty PROCEDURE

TV Annuloplasty will be performed using standard surgical techniques

MVS + TV Annuloplasty

MVS PROCEDURE

MVS will be performed using standard surgical techniques

MVS + TV Annuloplasty; MVS Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing MVS for degenerative MR\* with (a) Moderate TR as determined by transthoracic 2D echocardiography, or (b) Tricuspid annular dimension ≥ 40 mm (index: ≥21mm/M2 BSA) and none/trace or mild TR, determined by echocardiography.
• Age ≥ 18 years
• Able to sign Informed Consent and Release of Medical Information forms
• "Degenerative mitral valve disease refers to a spectrum of conditions in which morphologic changes in the connective tissues of the mitral valve cause structural lesions . . ., such as chordal elongation, chordal rupture, leaflet tissue expansion, and annular dilation typically resulting in mitral regurgitation due to leaflet prolapse." This definition excludes rheumatic heart disease. (Anyanwu AC, Adams DH. (2007) Etiological classification of degenerative mitral valve disease: Barlow's disease and fibroelasticity deficiency. Semin Thorac Cardiovasc Surg; 19(2): 90-6).

You may not qualify if:

• Functional MR
• Evidence of sub-optimal fluid management (e.g., lack of diuretics, weight in excess of dry weight) in the opinion of the cardiology investigator
• Structural / organic TV disease
• Severe TV regurgitation as determined by preoperative transthoracic echocardiography (TTE)
• Implanted pacemaker or defibrillator, where the leads cross the TV from the right atrium into the right ventricle
• Concomitant cardiac surgery other than atrial fibrillation correction surgery (PVI, Maze, LAA closure), closure of PFO or ASD, or CABG
• Cardiogenic shock at the time of randomization
• STEMI requiring intervention within 7 days prior to randomization
• Evidence of cirrhosis or hepatic synthetic failure
• Severe, irreversible pulmonary hypertension in the judgment of the investigator
• Pregnancy at the time of randomization
• Therapy with an investigational intervention at the time of screening, or plan to enroll patient in additional investigational intervention study during participation in this trial
• Any concurrent disease with life expectancy \< 2 years
• Unable or unwilling to provide informed consent
• Unable or unwilling to comply with study follow up in the opinion of the investigator

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• German Society for Thoracic and Cardiovascular Surgery: collaborator
• Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK): collaborator

Study Sites (41)

University of Southern California

Los Angeles, California, 90033, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Yale University School of Medicine - Yale-New Haven Hospital

New Haven, Connecticut, 06520-8039, United States

Location

Emory University

Atlanta, Georgia, 30308, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

MedStar Health

Columbia, Maryland, 21044, United States

Location

University of Michigan Health Services

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Stony Brook Hospital

Stony Brook, New York, 11790, United States

Location

Montefiore Einstein Heart Center

The Bronx, New York, 10467, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

WakeMed Clinical Research Institute

Raleigh, North Carolina, 27610, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Baylor College of Medicine

Houston, Texas, United States

Location

Baylor Research Institute

Plano, Texas, 75093, United States

Location

University of Virginia Health Systems

Charlottesville, Virginia, 22908, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

University of Alberta Hospital

Edmonton, Alberta, T6G2B7, Canada

Location

London Health Sciences

London, Ontario, N6A 5A5, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2W 1T8, Canada

Location

Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

Institut Universitaire de Cardiologie de Quebec (Hopital Laval)

Québec, Quebec, G1V 4G5, Canada

Location

Universitares Herzzentrum Hamburg

Berlin, Brandenburg, 11353, Germany

Location

Herzzentrum Leipzig

Berlin, Brandenburg, 13347, Germany

Location

University Hospital Frankfurt

Frankfurt, Hesse-Nassau, 60590, Germany

Location

University Medical Center Göttingen

Göttingen, Lower Saxony, Germany

Location

University Medical Center Jena

Jena, Thuringia, Germany

Location

HDZ NRW Bad Oeynhausen

Bad Oeynhausen, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, Germany

Location

Heart Center, University of Freiburg

Freiburg im Breisgau, Germany

Location

German Heart Center Munich

Munich, Germany

Location

Related Publications (1)

• 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.

  PMID: 34767705 DERIVED

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Annetine Gelijns
• Organization: Icahn School of Medicine at Mount Sinai

annetine.gelijns@mountsinai.org

212-659-9567

Study Officials

• Annetine C. Gelijns, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Richard Weisel, MD

  Toronto General Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 5, 2016
• Study Start: May 26, 2016
• Primary Completion: April 19, 2021
• Study Completion: April 19, 2021
• Last Updated: June 18, 2024
• Results First Posted: September 21, 2023

Record last verified: 2024-05

Locations

DE (9); US (24); CA (8)