Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease

Sponsor

Meshalkin Research Institute of Pathology of Circulation (Other)

Overall Status

Completed

CT.gov ID

NCT03278574

Collaborator

(none)

171

Enrollment

Arms

63.7

Actual Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Mitral Regurgitation	Procedure: Mitral valve repair Device: Ring annuloplasty with posterior band Device: Ring annuloplasty with complete ring	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

171 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 5, 2011

Actual Primary Completion Date :

Sep 29, 2014

Actual Study Completion Date :

Dec 26, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Flexible band

Mitral valve repair with flexible posterior annuloplasty band

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

Active Comparator: Complete ring

Mitral valve repair with complete rigid ring

Procedure: Mitral valve repair

Mitral valve repair with standard technique: resection of prolapsed leaflet and/or artificial neochordae implantation

Device: Ring annuloplasty with complete ring

Mitral valve annuloplasty using Cardiamed (Penza, Russia) complete semirigid ring

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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%).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Meshalkin Research Institute of Pathology of Circulation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Meshalkin Research Institute of Pathology of Circulation

ClinicalTrials.gov Identifier:

NCT03278574

Other Study ID Numbers:

25041214

First Posted:

Sep 11, 2017

Last Update Posted:

Sep 12, 2017

Last Verified:

Sep 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mitral Valve Insufficiency

Study Results

No Results Posted as of Sep 12, 2017