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

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

Detailed Description
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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.

Official Title
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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.

Conditions
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Tricuspid Regurgitation, Tricuspid Insufficiency

Intervention / Treatment
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* Device: Transcatheter Tricuspid Valve Repair


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Transcatheter Tricuspid Valve Repair|Transcatheter Tricuspid Valve Repair with Edwards Cardioband TR|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tricuspid Repair, Edwards Cardioband TR, Annuloplasty, Tricuspid Valve