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

Overview

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

Full Title of Study: “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.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 30, 2022

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

  • Device: Transcatheter Tricuspid Valve Repair
    • Transcatheter Tricuspid Valve Repair with Edwards Cardioband TR

Clinical Trial Outcome Measures

Primary Measures

  • Procedure Success
    • Time Frame: Hospital discharge, 2-7 days post-procedure
    • Reduction in severity of Tricuspid Regurgitation at discharge.

Secondary Measures

  • Major Adverse Event Rate
    • Time Frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
    • Rates of major adverse
  • Procedure Success
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Edwards Lifesciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Georg Nickenig, MD, Principal Investigator, Universitätsklinikum Bonn, Germany

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