Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease

Study Overview
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Brief Summary
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The study evaluates the results of mitral valve repair with flexible band in comparison with rigid ring in patients undergoing mitral valve repair for degenerative mitral valve disease

Detailed Description
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Currently, mitral ring selection is based on a surgeon's preference rather than evidence. Semirigid rings combine flexibility and stability; however, their clinical benefit has not been completely clarified. The present study aimed to compare the outcomes of mitral valve repair with a flexible posterior annuloplasty band versus complete semirigid ring in patients with degenerative mitral valve disease.

Official Title
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Mitral Valve Repair Using Flexible Bands Versus Complete Rings in Patients With Degenerative Mitral Valve Disease: a Prospective, Randomized Study

Conditions
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Mitral Regurgitation

Intervention / Treatment
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* Procedure: Mitral valve repair
* Device: Ring annuloplasty with posterior band
* Device: Ring annuloplasty with complete ring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: severe primary mitral regurgitation due to degenerative mitral valve disease Exclusion Criteria: previous open cardiac surgery, indication for concomitant aortic valve replacement, left ventricle impairment (ejection fraction < 40%).

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flexible band<br>Mitral valve repair with flexible posterior annuloplasty band | Procedure: Mitral valve repair<br>* Mitral valve repair with standard technique: resection of prolapsed leaflet and/or artificial neochordae implantation<br>Device: Ring annuloplasty with posterior band<br>* Mitral valve annuloplasty using Cardiamed (Penza, Russia) flexible posterior annuloplasty band<br>|
| Active Comparator: Complete ring<br>Mitral valve repair with complete rigid ring | Procedure: Mitral valve repair<br>* Mitral valve repair with standard technique: resection of prolapsed leaflet and/or artificial neochordae implantation<br>Device: Ring annuloplasty with complete ring<br>* Mitral valve annuloplasty using Cardiamed (Penza, Russia) complete semirigid ring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from significant mitral regurgitation | Significant mitral regurgitation is defined as moderate and severe mitral regurgitation. The severity of MR was evaluated and defined in accordance with the European Association of Echocardiography recommendations for the assessment of valvular regurgitation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | Continued existence at follow up | 12 months, 24 months | 
| Freedom from reoperations | Freedom from redo mitral valve surgery during follow up | 12 months, 24 months | 
| Freedom from severe MR recurrence | The severity of MR was evaluated and defined in accordance with the European Association of Echocardiography recommendations for the assessment of valvular regurgitation | 12 months |