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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Universitatsklinikum 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
        • Universitatsmedizin der Johannes Gutenberg Universitat 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 Alvaro 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Edwards Lifesciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 23, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Mitral Regurgitation

Clinical Trials on Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings