Transcatheter Repair of Mitral Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post Market Clinical Follow-Up (PMCF)
Status: Recruiting
Location: See all (37) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Mitral TEER patients eligible per the current approved indication after Heart Team discussion and agreement
• Patient is willing and able to attend all follow-up visits and to perform all tests
• Provision of written informed consent
Locations
Other Locations
Austria
Medizinische Universität Wien/AKH Wien
ACTIVE_NOT_RECRUITING
Vienna
Germany
Zentralklinik Bad Berka GmbH
RECRUITING
Bad Berka
Universitäts-Herzzentrum Freiburg Campus Bad Krozingen
RECRUITING
Bad Krozingen
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
RECRUITING
Bad Oeynhausen
Charité Berlin
ACTIVE_NOT_RECRUITING
Berlin
Charité Berlin
RECRUITING
Berlin
Immanuel Klinikum Bernau
ACTIVE_NOT_RECRUITING
Bernau Bei Berlin
Universitätsklinikum Bonn
RECRUITING
Bonn
Herzzentrum Universitaetsklinik Herzzentrum Universitaetsklinik Cologne
RECRUITING
Cologne
St.-Johannes-Hospital
ACTIVE_NOT_RECRUITING
Dortmund
Herzzentrum Universitätsklinik Dresden
ACTIVE_NOT_RECRUITING
Dresden
Uniklinikum Erlangen
RECRUITING
Erlangen
Contilia Herz- und Gefäßzentrum,Elisabeth-Krankenhaus Essen
RECRUITING
Essen
Westdeutsches Herzzentrum / Uniklinik Essen
RECRUITING
Essen
MVZ-CCB
RECRUITING
Frankfurt
Universitätsklinikum Giessen UKGM
RECRUITING
Giessen
Universitaeres Herzzentrum Goettingen
ACTIVE_NOT_RECRUITING
Göttingen
Kath. Marienkrankenhaus Hamburg GmbH
RECRUITING
Hamburg
Universitares Herzzentrum Hamburg
RECRUITING
Hamburg
Universitätsklinikum Schleswig-Holstein, Campus Kiel
RECRUITING
Kiel
Heart Centre of the University Leipzig
RECRUITING
Leipzig
Universitäres Herzzentrum Lübeck, Universitätsklinikum Schleswig-Holstein
RECRUITING
Lübeck
Universitätsmedizin der Johannes Gutenberg Universität Mainz
ACTIVE_NOT_RECRUITING
Mainz
Medizinische Klinik I- Campus Grosshadern
RECRUITING
München
Helios Klinikum Siegburg
RECRUITING
Siegburg
Universität Tuebingen
RECRUITING
Tübingen
Uniklinikum Ulm
ACTIVE_NOT_RECRUITING
Ulm
Greece
Hygeia Hospital
ACTIVE_NOT_RECRUITING
Athens
Italy
Ospedale del Cuore G. Pasquinucci Massa
ACTIVE_NOT_RECRUITING
Massa
IRCCS Ospedale San Raffaele
ACTIVE_NOT_RECRUITING
Milan
IRCCS Policlinico San Donato
ACTIVE_NOT_RECRUITING
San Donato Milanese
Netherlands
St. Antonius Ziekenhuis
ACTIVE_NOT_RECRUITING
Nieuwegein
Erasmus MC
ACTIVE_NOT_RECRUITING
Rotterdam
Poland
The Cardinal Stefan Wyszyński, Institute of Cardiology
ACTIVE_NOT_RECRUITING
Warsaw
Spain
Hospital Alvaro Cunqueiro
ACTIVE_NOT_RECRUITING
Vigo
Switzerland
Inselspital Bern
ACTIVE_NOT_RECRUITING
Bern
United Kingdom
Wythenshawe Hospital
ACTIVE_NOT_RECRUITING
Manchester
Contact Information
Primary
TMTT Clinical Affairs
TMTT_Clinical@edwards.com
+1 (949) 250
Time Frame
Start Date: 2019-08-23
Estimated Completion Date: 2031-03-31
Participants
Target number of participants: 1000
Authors
Adam Witkowski, Christian Butter, Helge Moellmann, Ilka Ott, Holger Nef, Ulrich Schaefer, Mohammad Sherif, Philipp Lurz, Volker Rudolph, Sinisa Markovic, Wolfgang Rottbauer, Tim Seidler, Johannes Brachmann, Antonio Serra, Sonia Petronio, Andrés Iñiguez, Federico De Marco, Martin Swaans, Matteo Montorfano, Stephan Von Bardeleben, Carmelo Grasso, Paolo Denti, Nicolas van Mieghem, Axel Linke, Sergio Berti, Giuseppe Tarantini, Konstantinos Spargias, Christian Hengstenberg, Maria del Trigo
Related Therapeutic Areas
Sponsors
Leads: Edwards Lifesciences