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

Meshalkin Research Institute of Pathology of Circulation308 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

308

Conditions

Tricuspid Regurgitation

Interventions

band implantationDEVICE

rigid ring implantationDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * moderate or severe tricuspid regurgitation Exclusion Criteria: * refusal to participate in the study

Locations (1)

MeshalkinRI

Novosibirsk, Russia

Outcomes

Primary Outcomes

tricuspid regurgitation

Time frame: 12 months

death

Time frame: 12 months

Secondary Outcomes

right ventricle function

Time frame: 12 months

Data from ClinicalTrials.gov

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