Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03779490

Acronym

TriBAND

Enrollment

150

Registered

2018-12-19

Start date

2019-07-24

Completion date

2027-12-31

Last updated

2023-04-06

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

Conditions

Tricuspid Insufficiency, Tricuspid Regurgitation

Keywords

Edwards Cardioband TR, Annuloplasty, Tricuspid Repair, Tricuspid Valve

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.

Interventions

DEVICETranscatheter Tricuspid Valve Repair

Transcatheter Tricuspid Valve Repair with Edwards Cardioband TR

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Procedure Success	Hospital discharge, 2-7 days post-procedure	Reduction in severity of Tricuspid Regurgitation at discharge.

Secondary

Measure	Time frame	Description
Major Adverse Event Rate	30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years	Rates of major adverse
Procedure Success	30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years	Reduction in severity of Tricuspid Regurgitation (TR) severity
Change in Quality of Life - KCCQ	30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years	Improvement in Quality of Life as assessed by KCCQ.
Change in Quality of Life - EQ-5D-5L	30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years	Improvement in Quality of Life as assessed by EQ-5D-5L

Countries

Germany, Spain, Switzerland

Outcome results

None listed

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