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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03144024

Acronym

BvsRR

Enrollment

308

Registered

2017-05-08

Start date

2016-09-14

Completion date

2019-09-14

Last updated

2020-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tricuspid Regurgitation

Keywords

Tricuspid Regurgitation, Insufficiency, Tricuspid Valve, Valvular Annuloplasty, Cardiac Valve Annulus Repair

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.

Interventions

DEVICEband implantation

DEVICErigid ring implantation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* moderate or severe tricuspid regurgitation

Exclusion criteria

* refusal to participate in the study

Design outcomes

Primary

Measure	Time frame
tricuspid regurgitation	12 months
death	12 months

Secondary

Measure	Time frame
right ventricle function	12 months

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026