Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease

Not Applicable

Completed

• Conditions: Mitral Regurgitation
• Interventions: Procedure: Mitral valve repair; Device: Ring annuloplasty with posterior band; Device: Ring annuloplasty with complete ring

• Registration Number: NCT03278574
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-09-05
• Primary Completion: 2014-09-29
• Study Completion: 2016-12-26
• Status Verified: 2017-09
• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-07
• Last Update Submitted: 2017-09-10
• Study First Posted: 2017-09-11
• Last Update Posted: 2017-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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%).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flexible band	Mitral valve repair	Mitral valve repair with flexible posterior annuloplasty band
Flexible band	Ring annuloplasty with posterior band	Mitral valve repair with flexible posterior annuloplasty band
Complete ring	Mitral valve repair	Mitral valve repair with complete rigid ring
Complete ring	Ring annuloplasty with complete ring	Mitral valve repair with complete rigid ring

Primary Outcome Measures

Name	Time	Method
Freedom from significant mitral regurgitation	12 months	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

Secondary Outcome Measures

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