MiCLASP Post Market Clinical Follow-Up (PMCF) Study (MiCLASP)

June 25, 2025 updated by: Edwards Lifesciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Wien, Austria, 1090
        • Active, not recruiting
        • Medizinische Universität Wien/AKH Wien
  • Germany
      • Bad Berka, Germany, 99438
        • Recruiting
        • Zentralklinik Bad Berka GmbH
        • Contact:
        • Principal Investigator:
          • Harald Lapp, Prof. Dr. med.
      • Berlin, Germany, 10117
        • Recruiting
        • Charite Berlin
        • Contact:
        • Principal Investigator:
          • Markus Reinthaler, Dr.
      • Berlin, Germany, 13353
        • Active, not recruiting
        • Charite Berlin
      • Frankfurt, Germany, 60389
        • Recruiting
        • MVZ-CCB
        • Contact:
        • Principal Investigator:
          • Claudia Walther, Dr. med.
      • Hamburg, Germany, 22087
        • Recruiting
        • Kath. Marienkrankenhaus Hamburg GmbH
        • Principal Investigator:
          • Edith Lubos, Dr.
        • Contact:
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitäres Herzzentrum Hamburg
        • Contact:
        • Principal Investigator:
          • Niklas Schofer
      • Kiel, Germany, 24105
        • Recruiting
        • Universitatsklinikum Schleswig-Holstein, Campus Kiel
        • Contact:
        • Principal Investigator:
          • Derk Frank, Prof. Dr. med.
      • Leipzig, Germany, 04289
    • Baden-Württemberg
      • Bad Krozingen, Baden-Württemberg, Germany, 79189
        • Recruiting
        • Universitäts-Herzzentrum Freiburg Campus Bad Krozingen
        • Contact:
        • Principal Investigator:
          • Christian Besler
      • Tübingen, Baden-Württemberg, Germany, 72074
      • Ulm, Baden-Württemberg, Germany, 89081
        • Active, not recruiting
        • Uniklinikum Ulm
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • Uniklinikum Erlangen
        • Contact:
        • Principal Investigator:
          • Mohamed Marwan, Prof. MD.
      • München, Bavaria, Germany, 81377
        • Recruiting
        • Medizinische Klinik I- Campus Grosshadern
        • Contact:
        • Principal Investigator:
          • Jörg Hausleiter, Prof.Dr.
    • Brandenburg
      • Bernau, Brandenburg, Germany, 16321
        • Active, not recruiting
        • Immanuel Klinikum Bernau
    • Hessen
      • Gießen, Hessen, Germany, 35392
    • Lower Saxony
      • Göttingen, Lower Saxony, Germany, 37075
        • Active, not recruiting
        • Universitaeres Herzzentrum Goettingen
    • Nordrhine Westfalia
      • Essen, Nordrhine Westfalia, Germany, 45138
        • Recruiting
        • Contilia Herz- und Gefäßzentrum,Elisabeth-Krankenhaus Essen
        • Contact:
        • Principal Investigator:
          • Thomas Schmitz, Dr.
      • Essen, Nordrhine Westfalia, Germany, 45122
        • Recruiting
        • Westdeutsches Herzzentrum / Uniklinik Essen
        • Contact:
        • Principal Investigator:
          • Tienush Rassaf, Prof.Dr.
    • North Rhine-Westphalia
      • Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
        • Recruiting
        • Herz- und Diabeteszentrum NRW - Bad Oeynhausen
        • Contact:
        • Principal Investigator:
          • Volker Rudolph, Prof.Dr.
      • Bonn, North Rhine-Westphalia, Germany, 32545
        • Recruiting
        • Universitätsklinikum Bonn
        • Contact:
        • Principal Investigator:
          • Georg Nickenig, Prof.Dr.
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Recruiting
        • Herzzentrum Universitaetsklinik Herzzentrum Universitaetsklinik Cologne
        • Contact:
        • Principal Investigator:
          • Stephan Baldus, Prof.Dr.
      • Dortmund, North Rhine-Westphalia, Germany, 44137
        • Active, not recruiting
        • St.-Johannes-Hospital
      • Mainz, North Rhine-Westphalia, Germany, 55313
        • Active, not recruiting
        • Universitätsmedizin der Johannes Gutenberg Universität Mainz
      • Siegburg, North Rhine-Westphalia, Germany, 53721
    • Saxonia
      • Dresden, Saxonia, Germany, 01307
        • Active, not recruiting
        • Herzzentrum Universitätsklinik Dresden
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Recruiting
        • Universitäres Herzzentrum Lübeck, Universitätsklinikum Schleswig-Holstein
        • Contact:
        • Principal Investigator:
          • Ingo Eitel, Prof.Dr.
  • Greece
      • Athens, Greece, 151 23
        • Active, not recruiting
        • Hygeia Hospital
  • Italy
      • Massa, Italy, 54100
        • Active, not recruiting
        • Ospedale del Cuore G. Pasquinucci Massa
      • San Donato Milanese, Italy, 20097
        • Active, not recruiting
        • IRCCS Policlinico San Donato
    • Lombardy
      • Milano, Lombardy, Italy, 20132
        • Active, not recruiting
        • IRCCS Ospedale San Raffaele
  • Netherlands
      • Nieuwegein, Netherlands, 3435
        • Active, not recruiting
        • St. Antonius Ziekenhuis
      • Rotterdam, Netherlands, 3015
        • Active, not recruiting
        • Erasmus MC
  • Poland
      • Warsaw, Poland, 04-628
        • Active, not recruiting
        • The Cardinal Stefan Wyszyński, Institute of Cardiology
  • Spain
      • Vigo, Spain, 36213
        • Active, not recruiting
        • Hospital Álvaro Cunqueiro
  • Switzerland
      • Bern, Switzerland, 3010
        • Active, not recruiting
        • Inselspital Bern
  • United Kingdom
      • Manchester, United Kingdom, M23 9LT
        • Active, not recruiting
        • Wythenshawe Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients at or over the age of 18 determined to require percutaneous reconstruction of an insufficient mitral valve [MR ≥ 2+ (PASCAL patients) or MR ≥ 3+ (PASCAL Precision patients)] by a Heart Team who assesses patient risk and anatomic suitability should be considered for inclusion in this trial.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with major adverse events (MAE rates)
Time Frame: 30 days
The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days
30 days
Change in mitral regurgitation severity (scale of 0-4+) by echocardiography
Time Frame: 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
Discharge: defined as discharge or 7 days post-procedure, whichever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Investigators

  • Principal Investigator: Philipp Lurz, Prof.Dr.med., Johannes Gutenberg University Mainz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2019

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 31, 2031

Study Registration Dates

First Submitted

December 19, 2019

First Submitted That Met QC Criteria

June 11, 2020

First Posted (Actual)

June 12, 2020

Study Record Updates

Last Update Posted (Actual)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 25, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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