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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03604484
Study type Interventional
Source Université Catholique de Louvain
Contact
Status Completed
Phase N/A
Start date May 1, 2009
Completion date January 1, 2017

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