MiCLASP Post Market Clinical Follow-Up (PMCF) Study

Recruiting

• Conditions: Mitral Insufficiency; Mitral Regurgitation

• Registration Number: NCT04430075
• Lead Sponsor: Edwards Lifesciences

Brief 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.

Detailed Description

The objectives of this clinical study are to collect data on the safety of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair and on the effectiveness of the Edwards PASCAL System and Edwards PASCAL Precision System in improving MR, functional status and quality of life in a post market setting.

Study Timeline

• Study Start: 2019-08-23
• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-30
• Primary Completion: 2025-12-31
• Study Completion: 2031-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Mitral TEER patients eligible per the current approved indication after Heart Team discussion and agreement
2. Patient is willing and able to attend all follow-up visits and to perform all tests
3. Provision of written informed consent

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in mitral regurgitation severity (scale of 0-4+) by echocardiography	Discharge: defined as discharge or 7 days post-procedure, whichever comes first	Mitral regurgitation severity will be assessed by echocardiography at timepoint discharge on a scale from 0-4+ and compared to timepoint baseline Mitral regurgitation severity
Number of patients with major adverse events (MAE rates)	30 days	The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days

Trial Locations

Locations (35)

Universitätsmedizin der Johannes Gutenberg Universität Mainz; 🇩🇪 Mainz, North Rhine-Westphalia, Germany

Helios Klinikum Siegburg; 🇩🇪 Siegburg, North Rhine-Westphalia, Germany

Medizinische Universität Wien/AKH Wien; 🇦🇹 Wien, Austria

Universität Tuebingen; 🇩🇪 Tübingen, Baden-Württemberg, Germany

Uniklinikum Erlangen; 🇩🇪 Erlangen, Bavaria, Germany

Immanuel Klinikum Bernau; 🇩🇪 Bernau, Brandenburg, Germany

Universitaeres Herzzentrum Goettingen; 🇩🇪 Göttingen, Lower Saxony, Germany

Westdeutsches Herzzentrum / Uniklinik Essen; 🇩🇪 Essen, Nordrhine Westfalia, Germany

Herz- und Diabeteszentrum NRW - Bad Oeynhausen; 🇩🇪 Bad Oeynhausen, North Rhine-Westphalia, Germany

Herzzentrum Universitaetsklinik Herzzentrum Universitaetsklinik Cologne; 🇩🇪 Cologne, North Rhine-Westphalia, Germany

St.-Johannes-Hospital; 🇩🇪 Dortmund, North Rhine-Westphalia, Germany

Universitäres Herzzentrum Lübeck, Universitätsklinikum Schleswig-Holstein; 🇩🇪 Lübeck, Schleswig-Holstein, Germany

Universitares Herzzentrum Hamburg; 🇩🇪 Hamburg, Germany

Charité Berlin; 🇩🇪 Berlin, Germany

MVZ-CCB; 🇩🇪 Frankfurt, Germany

Kath. Marienkrankenhaus Hamburg GmbH; 🇩🇪 Hamburg, Germany

Heart Centre of the University Leipzig; 🇩🇪 Leipzig, Germany

Universitätsklinikum Schleswig-Holstein, Campus Kiel; 🇩🇪 Kiel, Germany

Hygeia Hospital; 🇬🇷 Athens, Greece

IRCCS Ospedale San Raffaele; 🇮🇹 Milano, Lombardy, Italy

Ospedale del Cuore G. Pasquinucci Massa; 🇮🇹 Massa, Italy

IRCCS Policlinico San Donato; 🇮🇹 San Donato Milanese, Italy

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

Wythenshawe Hospital; 🇬🇧 Manchester, United Kingdom

Uniklinikum Ulm; 🇩🇪 Ulm, Baden-Württemberg, Germany

Universitätsklinikum Bonn; 🇩🇪 Bonn, North Rhine-Westphalia, Germany

Medizinische Klinik I- Campus Grosshadern; 🇩🇪 München, Bavaria, Germany

Contilia Herz- und Gefäßzentrum,Elisabeth-Krankenhaus Essen; 🇩🇪 Essen, Nordrhine Westfalia, Germany

Universitätsklinikum Giessen UKGM; 🇩🇪 Gießen, Hessen, Germany

Zentralklinik Bad Berka GmbH; 🇩🇪 Bad Berka, Germany

Herzzentrum Universitätsklinik Dresden; 🇩🇪 Dresden, Saxonia, Germany

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Hospital Alvaro Cunqueiro; 🇪🇸 Vigo, Spain

The Cardinal Stefan Wyszyński, Institute of Cardiology; 🇵🇱 Warsaw, Poland

Inselspital Bern; 🇨🇭 Bern, Switzerland