Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tricuspid Valve Annuloplasty Patients, undergoing mitral valve surgery with no significant tricuspid valve regurgitation despite tricuspid annular dilation, randomized to concomitant tricuspid valve annuloplasty. |
Procedure: Tricuspid Valve Annuloplasty
Concomitant Tricuspid Valve Annuloplasty in patients undergoing mitral valve surgery
|
| No Intervention: Conservative arm Patients, undergoing mitral valve surgery with no significant tricuspid valve regurgitation despite tricuspid annular dilation, randomized to mitral valve surgery without concomitant tricuspid valve annuloplasty. |
Outcome Measures
Primary Outcome Measures
- combination of all-cause mortality or heart failure hospitalisation [at 12 months post-surgery]
Secondary Outcome Measures
- 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.
- Duration of Hospital and ICU stay [postoperative phase]
- 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]
- progressive TR > 2+ post-surgery [3, 6, 12 and 18 months]
- cardiovascular mortality [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)
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ziekenhuis Oost-Limburg (General Hospital Genk) | Genk | Belgium | 3600 |
Sponsors and Collaborators
- Hasselt University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TVP Study