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

Not Applicable

Completed

• Conditions: Tricuspid Regurgitation
• Interventions: Device: rigid ring implantation; Device: band implantation

• Registration Number: NCT03144024
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

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

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.

Study Timeline

• Status Verified: 2016-09
• Study Start: 2016-09-14
• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-05
• Study First Posted: 2017-05-08
• Primary Completion: 2017-09-14
• Study Completion: 2019-09-14
• Last Update Submitted: 2020-07-19
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 308

Inclusion Criteria

• moderate or severe tricuspid regurgitation

Exclusion Criteria

• refusal to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rigid ring	rigid ring implantation	-
band	band implantation	-

Primary Outcome Measures

Name	Time	Method
tricuspid regurgitation	12 months
death	12 months

Secondary Outcome Measures

Name	Time	Method
right ventricle function	12 months

Trial Locations

Locations (1)

MeshalkinRI; 🇷🇺 Novosibirsk, Russian Federation