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Flexible Band vs Rigid Ring for Degenerative Mitral Valve Disease

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ClinicalTrials.gov Identifier: NCT03278574
Recruitment Status : Completed
First Posted : September 11, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

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

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Procedure: Mitral valve repair Device: Ring annuloplasty with posterior band Device: Ring annuloplasty with complete ring Not Applicable

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  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mitral Valve Repair Using Flexible Bands Versus Complete Rings in Patients With Degenerative Mitral Valve Disease: a Prospective, Randomized Study
Actual Study Start Date : September 5, 2011
Actual Primary Completion Date : September 29, 2014
Actual Study Completion Date : December 26, 2016

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%).

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT03278574     History of Changes
Other Study ID Numbers: 25041214
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: individual participant data is unavailable for security reason

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases