Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery

Université Catholique de Louvain0 sites106 target enrollmentMay 1, 2009

ConditionsTricuspid Valve Insufficiency

Overview

Phase: N/A
Intervention: Not specified
Conditions: Tricuspid Valve Insufficiency
Sponsor: Université Catholique de Louvain
Enrollment: 106
Primary Endpoint: Incidence of more than mild tricuspid insufficiency
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Single center randomized study to test whether a prophylactic tricuspid annuloplasty at the time of mitral valve procedure can improve clinical and echocardiographical outcomes.

Detailed Description

The optimal management of functional tricuspid regurgitation (FTR) in the setting of mitral valve operations remains controversial. The current practice is both center- and surgeon-specific with guidelines based on non-randomized data. A prospective randomized trial was performed to evaluate the worth of less-than-severe FTR repair during mitral valve procedures. A single center randomized study was designed to allocate patients with less-than-severe FTR undergoing mitral valve surgery to be prophylactically treated + tricuspid valve annuloplasty (TVP- or TVP+). These patients were analysed using longitudinal cardiopulmonary exercise capacity, echocardiographic follow-up, and cardiac magnetic resonance (CMR). The primary outcome was more than mild tricuspid regurgitation (TR) recurrence with vena contracta \>3mm. Secondary outcomes were maximal oxygen uptake (VO2 max) and right ventricular (RV) dimension and function.

Registry

clinicaltrials.gov

Start Date

May 1, 2009

End Date

January 1, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel