Status:
ACTIVE_NOT_RECRUITING
Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)
Lead Sponsor:
Edwards Lifesciences
Conditions:
Tricuspid Regurgitation
Tricuspid Insufficiency
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 24 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03779490
Start Date
July 24 2019
End Date
December 31 2027
Last Update
April 6 2023
Active Locations (14)
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1
Ulm University
Ulm, Bavaria, Germany, 89081
2
Universitätsklinik der Ruhr-Universität Bochum
Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
3
Herzzentrum der UniKlinik Köln
Cologne, North Rhine-Westphalia, Germany, 50924
4
Charité - Universitätsmedizin Campus Mitte
Berlin, Germany, 10117