Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease

NCT ID: NCT03278574

Last Updated: 2017-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-05

Study Completion Date

2016-12-26

Brief Summary

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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

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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

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Mitral Regurgitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Flexible band

Mitral valve repair with flexible posterior annuloplasty band

Group Type EXPERIMENTAL

Mitral valve repair

Intervention Type PROCEDURE

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

Ring annuloplasty with posterior band

Intervention Type DEVICE

Mitral valve annuloplasty using Cardiamed (Penza, Russia) flexible posterior annuloplasty band

Complete ring

Mitral valve repair with complete rigid ring

Group Type ACTIVE_COMPARATOR

Mitral valve repair

Intervention Type PROCEDURE

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

Ring annuloplasty with complete ring

Intervention Type DEVICE

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

Interventions

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Mitral valve repair

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

Intervention Type PROCEDURE

Ring annuloplasty with posterior band

Mitral valve annuloplasty using Cardiamed (Penza, Russia) flexible posterior annuloplasty band

Intervention Type DEVICE

Ring annuloplasty with complete ring

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

Intervention Type DEVICE

Eligibility Criteria

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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%).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 29237465 (View on PubMed)

Other Identifiers

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25041214

Identifier Type: -

Identifier Source: org_study_id

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