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MiCLASP Post Market Clinical Follow-Up (PMCF) Study
Sponsor: Edwards Lifesciences
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.
Official title: Transcatheter Repair of Mitral Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post Market Clinical Follow-Up (PMCF)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2019-08-23
Completion Date
2031-03-31
Last Updated
2025-06-26
Healthy Volunteers
No
Conditions
Interventions
Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System
Transcatheter Valve Repair with Edwards PASCAL and PASCAL Precision System
Locations (37)
Medizinische Universität Wien/AKH Wien
Vienna, Austria
Universitäts-Herzzentrum Freiburg Campus Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, Germany
Universität Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Uniklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Uniklinikum Erlangen
Erlangen, Bavaria, Germany
Medizinische Klinik I- Campus Grosshadern
München, Bavaria, Germany
Immanuel Klinikum Bernau
Bernau bei Berlin, Brandenburg, Germany
Universitätsklinikum Giessen UKGM
Giessen, Hesse, Germany
Universitaeres Herzzentrum Goettingen
Göttingen, Lower Saxony, Germany
Westdeutsches Herzzentrum / Uniklinik Essen
Essen, Nordrhine Westfalia, Germany
Contilia Herz- und Gefäßzentrum,Elisabeth-Krankenhaus Essen
Essen, Nordrhine Westfalia, Germany
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, North Rhine-Westphalia, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany
Herzzentrum Universitaetsklinik Herzzentrum Universitaetsklinik Cologne
Cologne, North Rhine-Westphalia, Germany
St.-Johannes-Hospital
Dortmund, North Rhine-Westphalia, Germany
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz, North Rhine-Westphalia, Germany
Helios Klinikum Siegburg
Siegburg, North Rhine-Westphalia, Germany
Herzzentrum Universitätsklinik Dresden
Dresden, Saxony, Germany
Universitäres Herzzentrum Lübeck, Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Germany
Charité Berlin
Berlin, Germany
Charité Berlin
Berlin, Germany
MVZ-CCB
Frankfurt, Germany
Universitares Herzzentrum Hamburg
Hamburg, Germany
Kath. Marienkrankenhaus Hamburg GmbH
Hamburg, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany
Heart Centre of the University Leipzig
Leipzig, Germany
Hygeia Hospital
Athens, Greece
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy
Ospedale del Cuore G. Pasquinucci Massa
Massa, Italy
IRCCS Policlinico San Donato
San Donato Milanese, Italy
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Erasmus MC
Rotterdam, Netherlands
The Cardinal Stefan Wyszyński, Institute of Cardiology
Warsaw, Poland
Hospital Alvaro Cunqueiro
Vigo, Spain
Inselspital Bern
Bern, Switzerland
Wythenshawe Hospital
Manchester, United Kingdom