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

NCT ID: NCT03144024

Last Updated: 2020-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 308 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-14
• Study Completion Date: 2019-09-14

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.

Conditions

Tricuspid Regurgitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

band

Group Type: EXPERIMENTAL

band implantation

Intervention Type: DEVICE

Rigid ring

Group Type: ACTIVE_COMPARATOR

rigid ring implantation

Intervention Type: DEVICE

Interventions

band implantation

Intervention Type: DEVICE

rigid ring implantation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• moderate or severe tricuspid regurgitation

Exclusion Criteria

• refusal to participate in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MeshalkinRI

Novosibirsk, , Russia

Countries

Russia

Other Identifiers

BvsRR

Identifier Type: -

Identifier Source: org_study_id