Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

Completed · Not applicable

Conditions studied: Mild Tricuspid Regurgitation, Moderate Tricuspid Regurgitation, Tricuspid Regurgitation

In brief

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.

Key facts

Study ID

NCT02675244

Run by

Icahn School of Medicine at Mount Sinai

People needed

401

Starts

2016-05-26

Expected to finish

2021-04-19

Last updated by the study team

2024-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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