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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Tricuspid Regurgitation; Tricuspid Insufficiency
• Intervention / Treatment: Device: Transcatheter Tricuspid Valve Repair

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Campus Mitte
  • Berlin, Germany, 12203
    • Berlin Charité-Benjamin Franklin
  • Bonn, Germany, 51312
    • Universitätsklinikum Bonn
  • Dresden, Germany, 01307
    • Herzzentrum Universitätsklinik Dresden
  • Erlangen, Germany, 91054
    • University Hospital Erlangen
  • Göttingen, Germany, 37075
    • Universitätsmedizin Göttingen, Herzzentrum Göttingen
  • Hamburg, Germany, 20099
    • Asklepios Klinik St. Georg
  • Hamburg, Germany, 20246
    • UKE Hamburg
  • Hamburg, Germany, 22087
    • Katholisches Marienkrankenhaus
  • Bayern
    • Ulm, Bayern, Germany, 89081
      • Ulm University
  • NRW
    • Cologne, NRW, Germany, 50924
      • Herzzentrum der Uniklinik Köln
  • North Rhine Westphalia
    • Bad Oeynhausen, North Rhine Westphalia, Germany, 32545
      • Universitätsklinik der Ruhr-Universität Bochum
• Spain
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cahal
• Switzerland
  • Bern, Switzerland, 3010
    • Universitätsspital Bern (Inselspital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Symptomatic patients with chronic functional tricuspid regurgitation (FTR)

Description

• 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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Georg Nickenig, MD, Universitätsklinikum Bonn, Germany

Publications and helpful links

General Publications

• Vernikouskaya I, Bertsche D, Rottbauer W, Rasche V. Deep learning-based framework for motion-compensated image fusion in catheterization procedures. Comput Med Imaging Graph. 2022 Jun;98:102069. doi: 10.1016/j.compmedimag.2022.102069. Epub 2022 May 13.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2019
• Primary Completion (Actual): September 30, 2022
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: December 15, 2018
• First Submitted That Met QC Criteria: December 15, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Annuloplasty; Tricuspid Valve; Edwards Cardioband TR; Tricuspid Repair
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: 2017-21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No