Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease

NCT03278574 — Not applicable, Completed, 171 participants, Meshalkin Research Institute of Pathology of Circulation

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

Registry	NCT03278574
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	171 (Actual)
Sponsor	Meshalkin Research Institute of Pathology of Circulation (Network)
Conditions	Mitral Regurgitation
Interventions	Mitral valve repair, Ring annuloplasty with posterior band, Ring annuloplasty with complete ring (Procedure, device)
Dates	start 2011-09-05, primary completion 2014-09-29, completion 2016-12-26, first posted 2017-09-11, last updated 2017-09-12

-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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Flexible band	Experimental	Procedure: Mitral valve repair; Device: Ring annuloplasty with posterior band	Mitral valve repair with flexible posterior annuloplasty band
Complete ring	Active comparator	Procedure: Mitral valve repair; Device: Ring annuloplasty with complete ring	Mitral valve repair with complete rigid ring

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

+Outcome measures

Primary outcomes

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 outcomes

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

Sex: All, ages: 18 Years to any

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%).

+Publications

Results publication: Bogachev-Prokophiev AV, Afanasyev AV, Zheleznev SI, Nazarov VM, Sharifulin RM, Karaskov AM. Mid-term results of mitral valve repair using flexible bands versus complete rings in patients with degenerative mitral valve disease: a prospective, randomized study. J Cardiothorac Surg. 2017 Dec 13;12(1):113. doi: 10.1186/s13019-017-0679-0. PMID 29237465

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