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 Details — Status: Recruiting

Administrative data

• NCT number: NCT01580436
• Other study ID #: TVP Study
• Status: Recruiting
• Phase: N/A
• First received: October 18, 2011
• Last updated: October 23, 2014
• Start date: August 2011

Study information

• Verified date: October 2014
• Source: Hasselt University
• Contact: David Verhaert, MD
• Phone: +32 089 32 70 91
• Email: david.verhaert[@]zol.be
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Tricuspid Valve Insufficiency

Intervention

Procedure:
• Tricuspid Valve Annuloplasty
Concomitant Tricuspid Valve Annuloplasty in patients undergoing mitral valve surgery

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg (General Hospital Genk)	Genk

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	combination of all-cause mortality or heart failure hospitalisation		at 12 months post-surgery	Yes
Secondary	RV function & geometry	volumes and ejection fraction Assessed by cardiac ultrasound and MRI	3, 6, 12 and 18 months	No
Secondary	Quality of Life	Change at follow-up, measured by SF-36 & Minnesota Living with Heart Failure scale.	6, 12 and 18 months	No
Secondary	Duration of Hospital and ICU stay		postoperative phase	No
Secondary	All-Cause Mortality		at 3, 6, 12 and 18 months post-surgery	Yes
Secondary	Hospitalization for Heart Failure		at 3, 6, 12 and 18 months post-surgery	Yes
Secondary	progressive TR > 2+ post-surgery		3, 6, 12 and 18 months	No
Secondary	cardiovascular mortality		at 3, 6, 12 and 18 months post-surgery	Yes
Secondary	Exercise Tolerance	Change at follow-up, by 6-minute walking distance and maximal exercise cyclo-ergometry (maximal aerobic capacity)	6, 12 and 18 months	No