Transcatheter Repair of Tricuspid Regurgitation With Cardioband TR System Post-Market Clinical Follow-Up Study (TriBAND): A European Prospective, Multicenter Post-market Clinical Follow-up Study to Assess Transcatheter Tricuspid Valve Repair With Edwards Cardioband TR System in Patients With Symptomatic Chronic Functional Tricuspid Regurgitation.

Edwards Lifesciences14 sites in 3 countries150 target enrollmentJuly 24, 2019

ConditionsTricuspid Regurgitation Tricuspid Insufficiency

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tricuspid Regurgitation
Sponsor: Edwards Lifesciences
Enrollment: 150
Locations: 14
Primary Endpoint: Procedure Success
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.

Detailed Description

The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System. This is a multi-center, prospective, single-arm Post-Market Clinical Follow up Study.

Registry

clinicaltrials.gov

Start Date

July 24, 2019

End Date

December 31, 2027

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Edwards Lifesciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Eighteen (18) years of age or older
•Moderate or greater functional Tricuspid Regurgitation (TR)
•Patient is eligible to receive the Edwards Cardioband TR System per the current approved indications for use.

Exclusion Criteria

•Patients deemed anatomically unsuitable for the device by echocardiography
•Patients in whom transesophageal echocardiography (TEE) is contraindicated
•Previous tricuspid valve repair or replacement
•Severe aortic, mitral and / or pulmonic valve stenosis
•Severe aortic, mitral and / or pulmonic valve regurgitation
•Renal Insufficiency requiring dialysis or severe kidney renal disease
•Life expectancy of less than twelve months
•Patient is pregnant or lactating

Outcomes

Primary Outcomes

Procedure Success

Time Frame: Hospital discharge, 2-7 days post-procedure

Reduction in severity of Tricuspid Regurgitation at discharge.

Secondary Outcomes

Major Adverse Event Rate(30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
Change in Quality of Life - EQ-5D-5L(30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
Change in Quality of Life - KCCQ(30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
Procedure Success(30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years)