Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03779490

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Insufficiency Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ulm University, Ulm, Bavaria, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Transcatheter Tricuspid Valve Repair

Device

Transcatheter Tricuspid Valve Repair with Edwards Cardioband TR

Primary outcomes

  1. Procedure Success

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

    Reduction in severity of Tricuspid Regurgitation at discharge.

Secondary outcomes

  1. Major Adverse Event Rate

    Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

    Rates of major adverse

  2. 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

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

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.

Acronym: TriBAND

Important dates

Study start
2019
Primary completion
2022
Study completion
2027
First posted
Dec 19, 2018
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.