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Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease

Primary Purpose

Mitral Regurgitation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mitral valve repair
Ring annuloplasty with posterior band
Ring annuloplasty with complete ring
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Flexible band

    Complete ring

    Arm Description

    Mitral valve repair with flexible posterior annuloplasty band

    Mitral valve repair with complete rigid ring

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Survival
    Continued existence at follow up
    Freedom from reoperations
    Freedom from redo mitral valve surgery during follow up
    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

    Full Information

    First Posted
    September 6, 2017
    Last Updated
    September 10, 2017
    Sponsor
    Meshalkin Research Institute of Pathology of Circulation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03278574
    Brief Title
    Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease
    Official Title
    Mitral Valve Repair Using Flexible Bands Versus Complete Rings in Patients With Degenerative Mitral Valve Disease: a Prospective, Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 5, 2011 (Actual)
    Primary Completion Date
    September 29, 2014 (Actual)
    Study Completion Date
    December 26, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Meshalkin Research Institute of Pathology of Circulation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mitral Regurgitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    171 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Flexible band
    Arm Type
    Experimental
    Arm Description
    Mitral valve repair with flexible posterior annuloplasty band
    Arm Title
    Complete ring
    Arm Type
    Active Comparator
    Arm Description
    Mitral valve repair with complete rigid ring
    Intervention Type
    Procedure
    Intervention Name(s)
    Mitral valve repair
    Intervention Description
    Mitral valve repair with standard technique: resection of prolapsed leaflet and/or artificial neochordae implantation
    Intervention Type
    Device
    Intervention Name(s)
    Ring annuloplasty with posterior band
    Intervention Description
    Mitral valve annuloplasty using Cardiamed (Penza, Russia) flexible posterior annuloplasty band
    Intervention Type
    Device
    Intervention Name(s)
    Ring annuloplasty with complete ring
    Intervention Description
    Mitral valve annuloplasty using Cardiamed (Penza, Russia) complete semirigid ring
    Primary Outcome Measure Information:
    Title
    Freedom from significant mitral regurgitation
    Description
    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
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Survival
    Description
    Continued existence at follow up
    Time Frame
    12 months, 24 months
    Title
    Freedom from reoperations
    Description
    Freedom from redo mitral valve surgery during follow up
    Time Frame
    12 months, 24 months
    Title
    Freedom from severe MR recurrence
    Description
    The severity of MR was evaluated and defined in accordance with the European Association of Echocardiography recommendations for the assessment of valvular regurgitation
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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%).

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    individual participant data is unavailable for security reason
    Citations:
    PubMed Identifier
    29237465
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease

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