Tricuspid Valve Insufficiency
Conditions
Keywords
Tricuspid Valve Insufficiency, Cardiac Valve Annuloplasty, Outcome Assessment (Health Care)
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.
Interventions
PROCEDURETricuspid Valve Annuloplasty
Concomitant Tricuspid Valve Annuloplasty in patients undergoing mitral valve surgery
Sponsors
Hasselt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| combination of all-cause mortality or heart failure hospitalisation | at 12 months post-surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| RV function & geometry | 3, 6, 12 and 18 months | volumes and ejection fraction Assessed by cardiac ultrasound and MRI |
| 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) |
| Hospitalization for Heart Failure | at 3, 6, 12 and 18 months post-surgery | — |
Countries
Belgium
Contacts
Primary ContactDavid Verhaert, MD
Backup ContactChris Beerts
Outcome results
None listed