Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

NCT ID: NCT02675244

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 401 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-26
• Study Completion Date: 2021-04-19

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.

Detailed Description

The tricuspid valve controls the flow of blood in your heart between the right ventricle and the right atrium. TR is a condition where the valve does not close fully when it is supposed to and blood can then leak back into the right atrium. When TR becomes severe, surgery is usually performed to correct it. The purpose of the research is to determine whether repairing a tricuspid valve in patients with mild to moderate TR, at the time of planned mitral valve surgery, would improve the heart health of those who receive it compared to those who do not. There are no new or "experimental" procedures being tested in this study: both the mitral valve procedure and the tricuspid valve repair procedure are well established surgeries and are regularly performed together in patients who have severe TR. The available evidence addressing this issue is not definite: it is based on less rigorous methods of investigation, and the results have been conflicting. The study being proposed here will use rigorous scientific methods and should result in a very high level of certainty about what surgical treatment is best for patients with your condition.

This study will enroll people scheduled for mitral valve surgery with mild to moderate tricuspid regurgitation.

Conditions

Mild Tricuspid Regurgitation; Moderate Tricuspid Regurgitation; Tricuspid Regurgitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MVS Alone

Participants will undergo mitral valve surgery alone.

Group Type: ACTIVE_COMPARATOR

MVS

Intervention Type: PROCEDURE

MVS will be performed using standard surgical techniques

MVS + TV Annuloplasty

Patients will undergo mitral valve surgery and tricuspid valve annuloplasty.

Group Type: ACTIVE_COMPARATOR

TV Annuloplasty

Intervention Type: PROCEDURE

TV Annuloplasty will be performed using standard surgical techniques

MVS

Intervention Type: PROCEDURE

MVS will be performed using standard surgical techniques

Interventions

TV Annuloplasty

TV Annuloplasty will be performed using standard surgical techniques

Intervention Type: PROCEDURE

MVS

MVS will be performed using standard surgical techniques

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

German Society for Thoracic and Cardiovascular Surgery

OTHER

Sponsor Role: collaborator

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Annetine Gelijns

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Annetine C. Gelijns, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Richard Weisel, MD

Role: STUDY_CHAIR

Toronto General Hospital

Locations

University of Southern California

Los Angeles, California, United States

Stanford University School of Medicine

Stanford, California, United States

Yale University School of Medicine - Yale-New Haven Hospital

New Haven, Connecticut, United States

Emory University

Atlanta, Georgia, United States

University of Maryland

Baltimore, Maryland, United States

Suburban Hospital

Bethesda, Maryland, United States

MedStar Health

Columbia, Maryland, United States

University of Michigan Health Services

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Columbia University Medical Center

New York, New York, United States

Stony Brook Hospital

Stony Brook, 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

WakeMed Clinical Research Institute

Raleigh, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Baylor Research Institute

Plano, Texas, United States

University of Virginia Health Systems

Charlottesville, Virginia, United States

University of Wisconsin

Madison, Wisconsin, United States

University of Alberta Hospital

Edmonton, Alberta, Canada

London Health Sciences

London, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, 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, Quebec, Canada

Universitares Herzzentrum Hamburg

Berlin, Brandenburg, Germany

Herzzentrum Leipzig

Berlin, Brandenburg, Germany

University Hospital Frankfurt

Frankfurt, Hesse-Nassau, 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

Countries

United States; Canada; Germany

References

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.

Reference Type: DERIVED

PMID: 34767705 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2U01HL088942-07

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 08-1078-0010

Identifier Type: -

Identifier Source: org_study_id