Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery

Not Applicable

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

• Registration Number: NCT01580436
• Lead Sponsor: Hasselt University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2012-04-18
• Study First Posted: 2012-04-19
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-23
• Last Update Posted: 2014-10-24
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Scheduled for mitral valve surgery
• Tricuspid Annular diameter > 40mm or >21mm/m²

Exclusion Criteria

• Tricuspid Regurgitation more than 2+
• Unable to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tricuspid Valve Annuloplasty	Tricuspid Valve Annuloplasty	Patients, undergoing mitral valve surgery with no significant tricuspid valve regurgitation despite tricuspid annular dilation, randomized to concomitant tricuspid valve annuloplasty.

Primary Outcome Measures

Name	Time	Method
combination of all-cause mortality or heart failure hospitalisation	at 12 months post-surgery

Secondary Outcome Measures

Name	Time	Method
Duration of Hospital and ICU stay	postoperative phase
progressive TR > 2+ post-surgery	3, 6, 12 and 18 months
RV function & geometry	3, 6, 12 and 18 months	volumes and ejection fraction Assessed by cardiac ultrasound and MRI
Quality of Life	6, 12 and 18 months	Change at follow-up, measured by SF-36 \& Minnesota Living with Heart Failure scale.
cardiovascular mortality	at 3, 6, 12 and 18 months post-surgery
All-Cause Mortality	at 3, 6, 12 and 18 months post-surgery
Hospitalization for Heart Failure	at 3, 6, 12 and 18 months post-surgery
Exercise Tolerance	6, 12 and 18 months	Change at follow-up, by 6-minute walking distance and maximal exercise cyclo-ergometry (maximal aerobic capacity)

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg (General Hospital Genk); 🇧🇪 Genk, Belgium