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Completed

NCT Number: NCT03278574

Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease

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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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%).

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Survival

    Time frame: 12 months, 24 months

    Continued existence at follow up

  2. Freedom from reoperations

    Time frame: 12 months, 24 months

    Freedom from redo mitral valve surgery during follow up

  3. 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

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2016
First posted
Sep 11, 2017
Registry last updated
Sep 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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