MiCLASP Post Market Clinical Follow-Up (PMCF) Study
MiCLASP
Transcatheter Repair of Mitral Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post Market Clinical Follow-Up (PMCF)
1 other identifier
observational
1,000
9 countries
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
Longer than P75 for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 23, 2019
CompletedFirst Submitted
Initial submission to the registry
December 19, 2019
CompletedFirst Posted
Study publicly available on registry
June 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2031
ExpectedJune 26, 2025
May 1, 2025
6.4 years
December 19, 2019
June 25, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Number of patients with major adverse events (MAE rates)
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
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
Interventions
Transcatheter Valve Repair with Edwards PASCAL and PASCAL Precision System
Eligibility Criteria
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.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Medizinische Universität Wien/AKH Wien
Vienna, 1090, Austria
Universitäts-Herzzentrum Freiburg Campus Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, 79189, Germany
Universität Tuebingen
Tübingen, Baden-Wurttemberg, 72074, Germany
Uniklinikum Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
Uniklinikum Erlangen
Erlangen, Bavaria, 91054, Germany
Medizinische Klinik I- Campus Grosshadern
München, Bavaria, 81377, Germany
Immanuel Klinikum Bernau
Bernau bei Berlin, Brandenburg, 16321, Germany
Universitätsklinikum Giessen UKGM
Giessen, Hesse, 35392, Germany
Universitaeres Herzzentrum Goettingen
Göttingen, Lower Saxony, 37075, Germany
Westdeutsches Herzzentrum / Uniklinik Essen
Essen, Nordrhine Westfalia, 45122, Germany
Contilia Herz- und Gefäßzentrum,Elisabeth-Krankenhaus Essen
Essen, Nordrhine Westfalia, 45138, Germany
Herz- und Diabeteszentrum NRW - Bad Oeynhausen
Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 32545, Germany
Herzzentrum Universitaetsklinik Herzzentrum Universitaetsklinik Cologne
Cologne, North Rhine-Westphalia, 50937, Germany
St.-Johannes-Hospital
Dortmund, North Rhine-Westphalia, 44137, Germany
Universitätsmedizin der Johannes Gutenberg Universität Mainz
Mainz, North Rhine-Westphalia, 55313, Germany
Helios Klinikum Siegburg
Siegburg, North Rhine-Westphalia, 53721, Germany
Herzzentrum Universitätsklinik Dresden
Dresden, Saxony, 01307, Germany
Universitäres Herzzentrum Lübeck, Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538, Germany
Zentralklinik Bad Berka GmbH
Bad Berka, 99438, Germany
Charité Berlin
Berlin, 10117, Germany
Charité Berlin
Berlin, 13353, Germany
MVZ-CCB
Frankfurt, 60389, Germany
Universitares Herzzentrum Hamburg
Hamburg, 20246, Germany
Kath. Marienkrankenhaus Hamburg GmbH
Hamburg, 22087, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105, Germany
Heart Centre of the University Leipzig
Leipzig, 04289, Germany
Hygeia Hospital
Athens, 151 23, Greece
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132, Italy
Ospedale del Cuore G. Pasquinucci Massa
Massa, 54100, Italy
IRCCS Policlinico San Donato
San Donato Milanese, 20097, Italy
St. Antonius Ziekenhuis
Nieuwegein, 3435, Netherlands
Erasmus MC
Rotterdam, 3015, Netherlands
The Cardinal Stefan Wyszyński, Institute of Cardiology
Warsaw, 04-628, Poland
Hospital Alvaro Cunqueiro
Vigo, 36213, Spain
Inselspital Bern
Bern, 3010, Switzerland
Wythenshawe Hospital
Manchester, M23 9LT, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philipp Lurz, Prof.Dr.med.
Johannes Gutenberg University Mainz
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2019
First Posted
June 12, 2020
Study Start
August 23, 2019
Primary Completion
December 31, 2025
Study Completion (Estimated)
March 31, 2031
Last Updated
June 26, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share