MiCLASP Post Market Clinical Follow-Up (PMCF) Study

Last updated: January 29, 2025
Sponsor: Edwards Lifesciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Mitral Valve Regurgitation

Treatment

Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System

Clinical Study ID

NCT04430075
2018-08
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Mitral TEER patients eligible per the current approved indication after Heart Teamdiscussion 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

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

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System
Phase:
Study Start date:
August 23, 2019
Estimated Completion Date:
March 31, 2031

Study 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.

Connect with a study center

  • Medizinische Universität Wien/AKH Wien

    Wien, 1090
    Austria

    Site Not Available

  • Universität Tuebingen

    Tübingen, Baden-Württemberg 72074
    Germany

    Active - Recruiting

  • Uniklinikum Ulm

    Ulm, Baden-Württemberg 89081
    Germany

    Site Not Available

  • Uniklinikum Erlangen

    Erlangen, Bavaria 91054
    Germany

    Active - Recruiting

  • Medizinische Klinik I- Campus Grosshadern

    München, Bavaria 81377
    Germany

    Active - Recruiting

  • Immanuel Klinikum Bernau

    Bernau, Brandenburg 16321
    Germany

    Site Not Available

  • Universitätsklinikum Giessen UKGM

    Gießen, Hessen 35392
    Germany

    Active - Recruiting

  • Universitaeres Herzzentrum Goettingen

    Göttingen, Lower Saxony 37075
    Germany

    Site Not Available

  • Contilia Herz- und Gefäßzentrum,Elisabeth-Krankenhaus Essen

    Essen, Nordrhine Westfalia 45138
    Germany

    Active - Recruiting

  • Westdeutsches Herzzentrum / Uniklinik Essen

    Essen, Nordrhine Westfalia 45122
    Germany

    Active - Recruiting

  • Herz- und Diabeteszentrum NRW - Bad Oeynhausen

    Bad Oeynhausen, North Rhine-Westphalia 32545
    Germany

    Active - Recruiting

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia 32545
    Germany

    Active - Recruiting

  • Herzzentrum Universitaetsklinik Herzzentrum Universitaetsklinik Cologne

    Cologne, North Rhine-Westphalia 50937
    Germany

    Active - Recruiting

  • St.-Johannes-Hospital

    Dortmund, North Rhine-Westphalia 44137
    Germany

    Site Not Available

  • Universitätsmedizin der Johannes Gutenberg Universität Mainz

    Mainz, North Rhine-Westphalia 55313
    Germany

    Site Not Available

  • Helios Klinikum Siegburg

    Siegburg, North Rhine-Westphalia 53721
    Germany

    Active - Recruiting

  • Herzzentrum Universitätsklinik Dresden

    Dresden, Saxonia 01307
    Germany

    Site Not Available

  • Universitäres Herzzentrum Lübeck, Universitätsklinikum Schleswig-Holstein

    Lübeck, Schleswig-Holstein 23538
    Germany

    Active - Recruiting

  • Zentralklinik Bad Berka GmbH

    Bad Berka, 99438
    Germany

    Active - Recruiting

  • Charité Berlin

    Berlin, 13353
    Germany

    Site Not Available

  • Klinikum Coburg

    Coburg, 96450
    Germany

    Site Not Available

  • MVZ-CCB

    Frankfurt, 60389
    Germany

    Active - Recruiting

  • Kath. Marienkrankenhaus Hamburg GmbH

    Hamburg, 22087
    Germany

    Active - Recruiting

  • Universitares Herzzentrum Hamburg

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105
    Germany

    Active - Recruiting

  • Heart Centre of the University Leipzig

    Leipzig, 04289
    Germany

    Active - Recruiting

  • HELIOS Klinikum Pforzheim

    Pforzheim, 75175
    Germany

    Site Not Available

  • Hygeia Hospital

    Athens, 151 23
    Greece

    Site Not Available

  • IRCCS Ospedale San Raffaele

    Milano, Lombardy 20132
    Italy

    Site Not Available

  • Policlinico V. Emmanuele Catania

    Catania, 95124
    Italy

    Site Not Available

  • Ospedale del Cuore G. Pasquinucci Massa

    Massa, 54100
    Italy

    Site Not Available

  • Policlinico Universitario Padova

    Padova, 35128
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Pisana

    Pisa, 56126
    Italy

    Site Not Available

  • IRCCS Policlinico San Donato

    San Donato Milanese, 20097
    Italy

    Site Not Available

  • St. Antonius Ziekenhuis

    Nieuwegein, 3435
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam, 3015
    Netherlands

    Site Not Available

  • The Cardinal Stefan Wyszyński, Institute of Cardiology

    Warsaw, 04-628
    Poland

    Site Not Available

  • Hospital de Sant Pau

    Barcelona, 08041
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Alvaro Cunqueiro

    Vigo, 36213
    Spain

    Site Not Available

  • Inselspital Bern

    Bern, 3010
    Switzerland

    Site Not Available

  • Royal Victoria Hospital

    Belfast, BT9 7AB
    United Kingdom

    Site Not Available

  • Wythenshawe Hospital

    Manchester, M23 9LT
    United Kingdom

    Site Not Available

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