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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