RecruitingNCT04430075

MiCLASP Post Market Clinical Follow-Up (PMCF) Study

Transcatheter Repair of Mitral Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post Market Clinical Follow-Up (PMCF)

Sponsor

Edwards Lifesciences

Enrollment

1,000 participants

Start Date

Aug 23, 2019

Study Type

OBSERVATIONAL

Conditions

Mitral Regurgitation Mitral Insufficiency

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System for people with mitral insufficiency and mitral regurgitation. The study is currently recruiting participants at 37 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEdwards 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

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NCT04430075

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