Tricuspid RegurgitationTriBANDNCT03779490
Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)
An observational study of Tricuspid Regurgitation and Tricuspid Insufficiency, run by Edwards Lifesciences at 14 sites in 3 countries.
Trial summary
The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation, Tricuspid Insufficiency
- What is being tested?
- Transcatheter Tricuspid Valve Repair
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 24 Jul 2019to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Symptomatic patients with chronic functional tricuspid regurgitation (FTR)
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Germany12 sites
Universitätsklinik der Ruhr-Universität Bochum
Bad Oeynhausen, North Rhine-Westphalia, 32545
Charité - Universitätsmedizin Campus Mitte
Berlin, 10117
Berlin Charité-Benjamin Franklin
Berlin, 12203
Universitätsklinikum Bonn
Bonn, 51312
Herzzentrum der UniKlinik Köln
Cologne, North Rhine-Westphalia, 50924
Herzzentrum Universitätsklinik Dresden
Dresden, 01307
University Hospital Erlangen
Erlangen, 91054
Universitätsmedizin Göttingen, Herzzentrum Göttingen
Göttingen, 37075
Asklepios Klinik St. Georg
Hamburg, 20099
UKE Hamburg
Hamburg, 20246
Katholisches Marienkrankenhaus
Hamburg, 22087
Ulm University
Ulm, Bavaria, 89081
About this study
Official 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.
The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.
Read the 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.
- Conditions
- Tricuspid Regurgitation, Tricuspid Insufficiency
- Being tested
- Transcatheter Tricuspid Valve Repair
- Keywords
- Edwards Cardioband TR, Annuloplasty, Tricuspid Repair, Tricuspid Valve
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Tricuspid Valve RepairDevice
Transcatheter Tricuspid Valve Repair with Edwards Cardioband TR
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure Success
Reduction in severity of Tricuspid Regurgitation at discharge.
Measured: Hospital discharge, 2-7 days post-procedure
Secondary outcomes (4)
Major Adverse Event Rate
Rates of major adverse
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Procedure Success
Reduction in severity of Tricuspid Regurgitation (TR) severity
Measured: 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.
Measured: 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
Measured: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start24 Jul 2019
- Primary completion30 Sep 2022
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Georg Nickenig, MD, Principal investigator, Universitätsklinikum Bonn, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779490
- Sponsor's protocol ID
- 2017-21
- Acronym
- TriBAND
- Status last verified
- Sep 2026
- First submitted
- 15 Dec 2018
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35576863