Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Randomized Evaluation of Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery

Conditions
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Tricuspid Valve Insufficiency

Intervention / Treatment
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* Procedure: Tricuspid Valve Annuloplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tricuspid Valve Annuloplasty<br>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<br>* Concomitant Tricuspid Valve Annuloplasty in patients undergoing mitral valve surgery<br>|
| No Intervention: Conservative arm<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| combination of all-cause mortality or heart failure hospitalisation |  | at 12 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tricuspid Valve Insufficiency, Cardiac Valve Annuloplasty, Outcome Assessment (Health Care)