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

Active, not recruiting

• Conditions: Tricuspid Regurgitation; Tricuspid Insufficiency

• Registration Number: NCT03779490
• Lead Sponsor: Edwards Lifesciences

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.

Study Timeline

• Study First Submitted: 2018-12-15
• Study First Submitted QC: 2018-12-15
• Study First Posted: 2018-12-19
• Study Start: 2019-07-24
• Primary Completion: 2022-09-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-06
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Major Adverse Event Rate	30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years	Rates of major adverse
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
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.
Procedure Success	30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years	Reduction in severity of Tricuspid Regurgitation (TR) severity

Trial Locations

Locations (14)

Universitätsklinik der Ruhr-Universität Bochum; 🇩🇪 Bad Oeynhausen, North Rhine Westphalia, Germany

Ulm University; 🇩🇪 Ulm, Bayern, Germany

Herzzentrum der UniKlinik Köln; 🇩🇪 Cologne, NRW, Germany

Berlin Charité-Benjamin Franklin; 🇩🇪 Berlin, Germany

Charité - Universitätsmedizin Campus Mitte; 🇩🇪 Berlin, Germany

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Asklepios Klinik St. Georg; 🇩🇪 Hamburg, Germany

Herzzentrum Universitätsklinik Dresden; 🇩🇪 Dresden, Germany

University Hospital Erlangen; 🇩🇪 Erlangen, Germany

UKE Hamburg; 🇩🇪 Hamburg, Germany

Universitätsmedizin Göttingen, Herzzentrum Göttingen; 🇩🇪 Göttingen, Germany

Katholisches Marienkrankenhaus; 🇩🇪 Hamburg, Germany

Hospital Universitario Ramón y Cahal; 🇪🇸 Madrid, Spain

Universitätsspital Bern (Inselspital); 🇨🇭 Bern, Switzerland