NCT03278574

Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mitral Regurgitation

Interventions

Type	Name	Description
PROCEDURE	Mitral valve repair	Mitral valve repair with standard technique: resection of prolapsed leaflet and/or artificial neochordae implantation
DEVICE	Ring annuloplasty with posterior band	Mitral valve annuloplasty using Cardiamed (Penza, Russia) flexible posterior annuloplasty band
DEVICE	Ring annuloplasty with complete ring	Mitral valve annuloplasty using Cardiamed (Penza, Russia) complete semirigid ring

Timeline

• Start date: 2011-09-05
• Primary completion: 2014-09-29
• Completion: 2016-12-26
• First posted: 2017-09-11
• Last updated: 2017-09-12