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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tricuspid Valve Annuloplasty | Experimental | Patients, undergoing mitral valve surgery with no significant tricuspid valve regurgitation despite tricuspid annular dilation, randomized to concomitant tricuspid valve annuloplasty. |
|
| Conservative arm | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tricuspid Valve Annuloplasty | Procedure | Concomitant Tricuspid Valve Annuloplasty in patients undergoing mitral valve surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| combination of all-cause mortality or heart failure hospitalisation | at 12 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| RV function & geometry | volumes and ejection fraction Assessed by cardiac ultrasound and MRI | 3, 6, 12 and 18 months |
| Quality of Life | Change at follow-up, measured by SF-36 & Minnesota Living with Heart Failure scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Verhaert, MD | Contact | +32 089 32 70 91 | david.verhaert@zol.be | |
| Chris Beerts | Contact | +32 089 32 71 91 | chris.beerts@zol.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg (General Hospital Genk) | Recruiting | Genk | 3600 | Belgium |
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 6, 12 and 18 months |
| 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 | Change at follow-up, by 6-minute walking distance and maximal exercise cyclo-ergometry (maximal aerobic capacity) | 6, 12 and 18 months |