MiCLASP Post Market Clinical Follow-Up (PMCF) Study

Recruiting now

Conditions studied: Mitral Regurgitation, Mitral Insufficiency

In brief

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.

Key facts

Study ID

NCT04430075

Run by

Edwards Lifesciences

People needed

1000

Starts

2019-08-23

Expected to finish

2031-03-31

Last updated by the study team

2025-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients are not eligible per the current Instructions for Use
• Non-elective or emergency TEER procedure for mitral regurgitation
• Patients in ICU prior to the index procedure

Where it is running

• Zentralklinik Bad Berka GmbH — Bad Berka, Germany (enrolling)
• Charité Berlin — Berlin, Germany (enrolling)
• Universitätsklinikum Giessen UKGM — Giessen, Hesse, Germany (enrolling)
• MVZ-CCB — Frankfurt, Germany (enrolling)
• Universitares Herzzentrum Hamburg — Hamburg, Germany (enrolling)
• Kath. Marienkrankenhaus Hamburg GmbH — Hamburg, Germany (enrolling)
• Universitätsklinikum Schleswig-Holstein, Campus Kiel — Kiel, Germany (enrolling)
• Heart Centre of the University Leipzig — Leipzig, Germany (enrolling)
• Universitäts-Herzzentrum Freiburg Campus Bad Krozingen — Bad Krozingen, Baden-Wurttemberg, Germany (enrolling)
• Westdeutsches Herzzentrum / Uniklinik Essen — Essen, Nordrhine Westfalia, Germany (enrolling)
• Contilia Herz- und Gefäßzentrum,Elisabeth-Krankenhaus Essen — Essen, Nordrhine Westfalia, Germany (enrolling)
• Herz- und Diabeteszentrum NRW - Bad Oeynhausen — Bad Oeynhausen, North Rhine-Westphalia, Germany (enrolling)
• Universitätsklinikum Bonn — Bonn, North Rhine-Westphalia, Germany (enrolling)
• Herzzentrum Universitaetsklinik Herzzentrum Universitaetsklinik Cologne — Cologne, North Rhine-Westphalia, Germany (enrolling)
• Uniklinikum Erlangen — Erlangen, Bavaria, Germany (enrolling)
• Medizinische Klinik I- Campus Grosshadern — München, Bavaria, Germany (enrolling)
• Helios Klinikum Siegburg — Siegburg, North Rhine-Westphalia, Germany (enrolling)
• Universität Tuebingen — Tübingen, Baden-Wurttemberg, Germany (enrolling)
• Universitäres Herzzentrum Lübeck, Universitätsklinikum Schleswig-Holstein — Lübeck, Schleswig-Holstein, Germany (enrolling)
• Wythenshawe Hospital — Manchester, United Kingdom
• Uniklinikum Ulm — Ulm, Baden-Wurttemberg, Germany
• Immanuel Klinikum Bernau — Bernau bei Berlin, Brandenburg, Germany
• Universitaeres Herzzentrum Goettingen — Göttingen, Lower Saxony, Germany
• St.-Johannes-Hospital — Dortmund, North Rhine-Westphalia, Germany
• Universitätsmedizin der Johannes Gutenberg Universität Mainz — Mainz, North Rhine-Westphalia, Germany

Full record on ClinicalTrials.gov

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