Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

Status: Completed
Location: See all (41) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
California
University of Southern California
Los Angeles
Stanford University School of Medicine
Stanford
Connecticut
Yale University School of Medicine - Yale-New Haven Hospital
New Haven
Georgia
Emory University
Atlanta
Maryland
University of Maryland
Baltimore
Suburban Hospital
Bethesda
MedStar Health
Columbia
Michigan
University of Michigan Health Services
Ann Arbor
Minnesota
Mayo Clinic
Rochester
North Carolina
Mission Hospital
Asheville
Duke University
Durham
WakeMed Clinical Research Institute
Raleigh
New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon
New York
Montefiore Einstein Heart Center
Bronx
Columbia University Medical Center
New York
Stony Brook Hospital
Stony Brook
Ohio
Cleveland Clinic
Cleveland
Ohio State University
Columbus
Pennsylvania
University of Pennsylvania
Philadelphia
Texas
Baylor College of Medicine
Houston
Baylor College of Medicine
Houston
Baylor Research Institute
Plano
Virginia
University of Virginia Health Systems
Charlottesville
Wisconsin
University of Wisconsin
Madison
Other Locations
Canada
University of Alberta Hospital
Edmonton
London Health Sciences
London
Centre Hospitalier de l'Université de Montréal
Montreal
Hôpital du Sacré-Cœur de Montréal
Montreal
Montreal Heart Institute
Montreal
University of Ottawa Heart Institute
Ottawa
Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
Quebec
Toronto General Hospital
Toronto
Germany
HDZ NRW Bad Oeynhausen
Bad Oeynhausen
Deutsches Herzzentrum Berlin
Berlin
Herzzentrum Leipzig
Berlin
Universitares Herzzentrum Hamburg
Berlin
University Hospital Frankfurt
Frankfurt
Heart Center, University of Freiburg
Freiburg
University Medical Center Göttingen
Göttingen
University Medical Center Jena
Jena
German Heart Center Munich
Munich
Time Frame
Start Date: 2016-05-26
Completion Date: 2021-04-19
Participants
Target number of participants: 401
Treatments
Active_comparator: MVS Alone
Participants will undergo mitral valve surgery alone.
Active_comparator: MVS + TV Annuloplasty
Patients will undergo mitral valve surgery and tricuspid valve annuloplasty.
Related Therapeutic Areas
Sponsors
Collaborators: German Society for Thoracic and Cardiovascular Surgery, Canadian Institutes of Health Research (CIHR), Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), National Heart, Lung, and Blood Institute (NHLBI)
Leads: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov