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Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery

Tricuspid Valve Insufficiency Clinical Trial

Official title:
Prospective, Randomized Evaluation of Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery

Clinical Trial Summary

De novo or progressive tricuspid regurgitation (TR) is not uncommonly observed following mitral valve surgery and associated with worse outcome. Hence, concomitant tricuspid valve annuloplasty (TVP) has been recommended for patients undergoing mitral valve surgery when tricuspid annular dilatation is present even in absence of significant TR. However, whether such a strategy of "prophylactic TVP" results in improved outcomes has not been shown to date by a prospective randomized study. The investigators goal is therefore to initiate such a study and evaluate the effect of concomitant TVP on mid- and long-term outcome in patients scheduled for mitral valve surgery and tricuspid annular dilatation but <2+ TR.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01580436
Study type Interventional
Source Hasselt University
Contact David Verhaert, MD
Phone +32 089 32 70 91
Email david.verhaert@zol.be
Status Recruiting
Phase N/A
Start date August 2011
View Details
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