Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery

Not Applicable

Completed

• Conditions: Tricuspid Valve Insufficiency
• Interventions: Procedure: Tricuspid annuloplasty

• Registration Number: NCT03604484
• Lead Sponsor: Université Catholique de Louvain

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.

Study Timeline

• Study Start: 2009-05-01
• Primary Completion: 2010-12-31
• Study Completion: 2017-01-01
• Status Verified: 2018-07
• Study First Submitted: 2018-07-11
• Study First Submitted QC: 2018-07-19
• Last Update Submitted: 2018-07-19
• Study First Posted: 2018-07-27
• Last Update Posted: 2018-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• patients undergoing mitral valve surgery with less than sever tricuspid insufficiency

Exclusion Criteria

• presence of pacemaker lead through the tricuspid valve
• acute endocarditis
• minimally invasive approach
• Functional mitral valve insufficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tricuspid annuloplasty	Tricuspid annuloplasty	Patient treated with tricuspid annuloplasty at the moment of the mitral valve surgery

Primary Outcome Measures

Name	Time	Method
Incidence of more than mild tricuspid insufficiency	5 year

Secondary Outcome Measures

Name	Time	Method
VO2 max	1 year	Physical function capacity measured by VO2 max
Right ventricular function	5 year	Right ventricle function at the follow up