NCT01580436

Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Hasselt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tricuspid Valve Insufficiency

Interventions

Type	Name	Description
PROCEDURE	Tricuspid Valve Annuloplasty	Concomitant Tricuspid Valve Annuloplasty in patients undergoing mitral valve surgery

Timeline

• Start date: 2011-08-01
• Primary completion: 2017-12-01
• First posted: 2012-04-19
• Last updated: 2014-10-24

Locations

1 site across 1 country: Belgium