Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)
NCT ID: NCT03779490
Last Updated: 2023-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
150 participants
OBSERVATIONAL
2019-07-24
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Transcatheter Tricuspid Valve Repair
Transcatheter Tricuspid Valve Repair with Edwards Cardioband TR
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Georg Nickenig, MD
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Bonn, Germany
Locations
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Ulm University
Ulm, Bavaria, Germany
Universitätsklinik der Ruhr-Universität Bochum
Bad Oeynhausen, North Rhine-Westphalia, Germany
Herzzentrum der UniKlinik Köln
Cologne, North Rhine-Westphalia, Germany
Charité - Universitätsmedizin Campus Mitte
Berlin, , Germany
Berlin Charité-Benjamin Franklin
Berlin, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
Herzzentrum Universitätsklinik Dresden
Dresden, , Germany
University Hospital Erlangen
Erlangen, , Germany
Universitätsmedizin Göttingen, Herzzentrum Göttingen
Göttingen, , Germany
Asklepios Klinik St. Georg
Hamburg, , Germany
UKE Hamburg
Hamburg, , Germany
Katholisches Marienkrankenhaus
Hamburg, , Germany
Hospital Universitario Ramón y Cahal
Madrid, , Spain
Universitätsspital Bern (Inselspital)
Bern, , Switzerland
Countries
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References
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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.
Other Identifiers
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2017-21
Identifier Type: -
Identifier Source: org_study_id
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