Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency

Overview

randomized study which include comparison rigid ring and band devices in treatment tricuspid regurgitation.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: September 14, 2017

Detailed Description

study include 308 patients. Patient will be randomized and 154 patient will receive band for treatment tricuspid regurgitation, rest patient will receive rigid ring. Follow up will be 1 year. Primary outcome – freedom of moderate or severe regurgitation. Secondary outcome – RV function, quality of life.

Interventions

  • Device: band implantation
  • Device: rigid ring implantation

Arms, Groups and Cohorts

  • Experimental: band
  • Active Comparator: Rigid ring

Clinical Trial Outcome Measures

Primary Measures

  • tricuspid regurgitation
    • Time Frame: 12 months
  • death
    • Time Frame: 12 months

Secondary Measures

  • right ventricle function
    • Time Frame: 12 months

Participating in This Clinical Trial

Inclusion Criteria

  • moderate or severe tricuspid regurgitation

Exclusion Criteria

  • refusal to participate in the study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Meshalkin Research Institute of Pathology of Circulation
  • Provider of Information About this Clinical Study
    • Sponsor

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