An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated with the Abbott TriClip™ Device
Status: Active_not_recruiting
Location: See all (26) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
The bRIGHT EU PAS study is an observational real-world study evaluating severe tricuspid regurgitation patients treated with the Abbott TriClip™ device (bRIGHT EU Post-Approval Study).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Subjects (\>=18 years age) have severe tricuspid regurgitation and are symptomatic despite medical therapy.
• Subjects eligible to receive the TriClip™ per the current approved Indications for Use.
• Subject must provide written informed consent prior to study procedure.
Locations
Other Locations
Austria
Universitätsklinik Graz
Graz
Denmark
Odense University Hospital
Odense
Germany
Zentralklinik Bad Berka GmbH
Bad Berka
Herz-und Diabetes Zentrum NRW
Bad Oeynhausen
Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG
Bad Rothenfelde
DRK Kliniken Köpenick
Berlin
University Hospital Bonn
Bonn
St.-Johannes-Hospital
Dortmund
Elisabeth-Krankenhaus Essen GmbH
Essen
Katholisches Marienkrankenhaus GmbH
Hamburg
UKE Hamburg (Universitatsklinik Eppendorf)
Hamburg
Leipzig Heart Center
Leipzig
Otto-von-Guericke-Universität Magdeburg
Magdeburg
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz
Robert-Bosch-Krankenhaus
Stuttgart
Universitätsklinikum Ulm
Ulm
Italy
Maria Cecilia Hospital
Cotignola
Azienda Ospedaliera Monaldi
Napoli
Universita degli Studi di Padova
Padova
Netherlands
St. Antonius Ziekenhuis
Nieuwegein
Portugal
Centro Hospitalar Vila Nova de Gaia
Porto
Spain
Clinical and Provincial Hospital of Barcelona
Barcelona
Hospital de Sant Pau
Barcelona
Hospital Álvaro Cunqueiro
Vigo
Switzerland
Inselspital Bern
Bern
HerzKlinik Hirslanden - Klinik Hirslanden
Zurich
Time Frame
Start Date: 2020-08-27
Completion Date: 2028-01
Participants
Target number of participants: 511
Authors
Prof. Fabien Praz, Dr. Dabit Arzamendi, Prof. Antonio Colombo, Prof. Helge Möllmann, Prof. Raffi Bekeredjian, Prof. Iskandar Atmowihardjo, Prof. Harald Lapp, Dr. Ralph Stephan von Bardeleben, Prof. Jorg Hausleiter, Dr. Marek Kowalski, Prof. Volker Rudolph, Dr. Sinisa Markovic, Prof. Alexander Schmeisser, Prof. Robert Schueler, Prof. Ulrich Schaefer, Dr. Bruno Melica, Prof. Georg Nickenig, Prof. Edith Lubos, Prof. Giuseppe Tarantini, Dr. Matteo Montorfano, Prof. Andreas Zirlik, Dr. Fausto Castriota, Dr. Paolo Golino, Dr. Xavier Freixa, Prof. Philipp Lurz, Prof. Benno Rensing, Dr. Karsten Veien, Dr. Francesco Bedogni, Prof. Roberto Corti
Related Therapeutic Areas
Sponsors
Leads: Abbott Medical Devices