Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease

Mitral Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03278574
• Other study ID #: 25041214
• Status: Completed
• Phase: N/A
• First received: September 6, 2017
• Last updated: September 10, 2017
• Start date: September 5, 2011
• Est. completion date: December 26, 2016

Study information

• Verified date: September 2017
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: December 26, 2016
• Est. primary completion date: September 29, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%).

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Survival	Continued existence at follow up	12 months, 24 months
Secondary	Freedom from reoperations	Freedom from redo mitral valve surgery during follow up	12 months, 24 months
Secondary	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