Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease

Meshalkin Research Institute of Pathology of Circulation

Status: Completed

Conditions: Mitral Regurgitation

Treatments: Procedure: Mitral valve repair; Device: Ring annuloplasty with complete ring; Device: Ring annuloplasty with posterior band

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03278574

25041214

Details and patient eligibility

About

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

Full 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.

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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171 participants in 2 patient groups

Flexible band

Experimental group

Description:

Mitral valve repair with flexible posterior annuloplasty band

Treatment:

Procedure: Mitral valve repair

Device: Ring annuloplasty with posterior band

Complete ring

Active Comparator group

Description:

Mitral valve repair with complete rigid ring

Treatment:

Procedure: Mitral valve repair

Device: Ring annuloplasty with complete ring