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

Meshalkin Research Institute of Pathology of Circulation

Status: Completed

Conditions: Tricuspid Regurgitation

Treatments: Device: band implantation; Device: rigid ring implantation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03144024

BvsRR

Details and patient eligibility

About

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

Full 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.

Enrollment: 308 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• moderate or severe tricuspid regurgitation

Exclusion criteria

• refusal to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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308 participants in 2 patient groups

band

Experimental group

Treatment:

Device: band implantation

Rigid ring

Active Comparator group

Treatment:

Device: rigid ring implantation