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.
Status: Active_not_recruiting
Location: See all (14) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ 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.
Locations
Other Locations
Germany
Universitätsklinik der Ruhr-Universität Bochum
Bad Oeynhausen
Berlin Charité-Benjamin Franklin
Berlin
Charité - Universitätsmedizin Campus Mitte
Berlin
Universitätsklinikum Bonn
Bonn
Herzzentrum der UniKlinik Köln
Cologne
Herzzentrum Universitätsklinik Dresden
Dresden
University Hospital Erlangen
Erlangen
Universitätsmedizin Göttingen, Herzzentrum Göttingen
Göttingen
Asklepios Klinik St. Georg
Hamburg
Katholisches Marienkrankenhaus
Hamburg
UKE Hamburg
Hamburg
Ulm University
Ulm
Spain
Hospital Universitario Ramón y Cahal
Madrid
Switzerland
Universitätsspital Bern (Inselspital)
Bern
Time Frame
Start Date: 2019-07-24
Completion Date: 2027-12-31
Participants
Target number of participants: 150
Authors
Edith Lubos, Jörg Kempfert, Helge Möllmann, Henryk Dreger, Ulrich Schäfer, Markus Kasel, Jörg Hausleiter, Georg Nickenig, Kai Friedrichs, Claudius Jacobshagen, martin Arnold, Alexander Lauten, Stephan Baldus, Christian Frerker, Norbert Franz, Samer Hakmi, Tim Seidler, Markus Reinthaler, Magnus Settergren, Stephan Von Bardeleben, Stephan Windecker, Axel Linke, Maurizio Taramasso, Raban Jeger
Related Therapeutic Areas
Sponsors
Leads: Edwards Lifesciences