The RELIEF Trial: REduction or eLimination of mItral rEgurgitation in Degenerative or Functional Mitral Regurgitation With the CardiAQ-Edwards™ Transcatheter Mitral Valve
Status: Withdrawn
Location: See all (15) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
Clinical study to evaluate the safety and performance of the CardiAQ-Edwards™ Transcatheter Mitral Valve
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• NYHA ≥ II
• Moderate/severe or severe mitral regurgitation
• Prohibitive risk for open-heart surgery
• Meets anatomical criteria
Locations
Other Locations
Canada
Centre de recherche Institut Universitaire de Cardiologie et de Pneumologie de Québec (CRIUCPQ)
Quebec
Centre Toronto General Hospital
Toronto
St. Michael's Hospital
Toronto
St. Paul's Hospital, University of British Columbia
Vancouver
Denmark
Rigshospitalet
Copenhagen
France
Centre Hospitalier Régional Universitaire de Lille
Lille
Germany
Kerckhoff-Klinik GmbH
Bad Nauheim
Deutsche Herzzentrum Berlin
Berlin
University Heart Centre
Hamburg
Herzzentrum der UniKlinik Köln
Köln
Leipzig Herzzentrum
Leipzig
Italy
Ospedale San Raffaele
Milano
Universita di Roma Tor Vergata
Roma
Netherlands
Erasmus Medical Centre
Rotterdam
Switzerland
InselSpital Bern
Bern
Time Frame
Start Date: 2016-11
Completion Date: 2024-10
Treatments
Experimental: Treatment
Treatment with the CardiAQ-Edwards™ Transcatheter Mitral Valve (transapical or transseptal delivery)
Authors
Nico van Mieghem, Dr. John Webb, Antonio Colombo, Dr. Mark Peterson, Susanne Holme, Jörg Kempfert, Helge Möllmann, Hendrik Treede, Thomas Modine, Arnaud Sudre, Thomas Walther, Stephan Baldus, Thorsten Wahlers, Ulrich Schäfer, Francesco Romeo, Dr Eric Dumont, Dr Francois Dagenais, Arie Pieter Kappetein, Gian Paolo Ussia, Dr Mark Osten, Thierry Carrel, Dr. Jian Ye, Dr. Neil Fam, Ottavio Alfieri, Volkmar Falk, Axel Linke, Lars Sondergaard, Dr Eric Horlick, Stephan Windecker
Related Therapeutic Areas
Sponsors
Leads: Edwards Lifesciences