Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease

September 10, 2017 updated by: Meshalkin Research Institute of Pathology of Circulation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

171

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from significant mitral regurgitation
Time Frame: 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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 12 months, 24 months
Continued existence at follow up
12 months, 24 months
Freedom from reoperations
Time Frame: 12 months, 24 months
Freedom from redo mitral valve surgery during follow up
12 months, 24 months
Freedom from severe MR recurrence
Time Frame: 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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2011

Primary Completion (Actual)

September 29, 2014

Study Completion (Actual)

December 26, 2016

Study Registration Dates

First Submitted

September 6, 2017

First Submitted That Met QC Criteria

September 7, 2017

First Posted (Actual)

September 11, 2017

Study Record Updates

Last Update Posted (Actual)

September 12, 2017

Last Update Submitted That Met QC Criteria

September 10, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25041214

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

individual participant data is unavailable for security reason

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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