Prospective, Randomized Evaluation of Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Tricuspid Valve Insufficiency
- Sponsor
- Hasselt University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- combination of all-cause mortality or heart failure hospitalisation
- Last Updated
- 11 years ago
Overview
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.
Investigators
Wilfried Mullens, MD PhD
Professor Cardiovascular Physiology
Hasselt University
Eligibility Criteria
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
Outcomes
Primary Outcomes
combination of all-cause mortality or heart failure hospitalisation
Time Frame: at 12 months post-surgery
Secondary Outcomes
- Duration of Hospital and ICU stay(postoperative phase)
- progressive TR > 2+ post-surgery(3, 6, 12 and 18 months)
- Quality of Life(6, 12 and 18 months)
- cardiovascular mortality(at 3, 6, 12 and 18 months post-surgery)
- RV function & geometry(3, 6, 12 and 18 months)
- 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)