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Clinical Trials in the UK / NCT04430075
Active, not recruiting Observational

MiCLASP Post Market Clinical Follow-Up (PMCF) Study

NCT04430075 · tracked via the Priya Life Science UK tracker
Sponsor
Edwards Lifesciences
Phase
Observational
Started
2019-08-23
Last updated
2026-08-19

Condition(s) studied

Mitral RegurgitationMitral Insufficiency

Investigational drug(s) / intervention(s)

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

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

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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
  • 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

Trial sites (37)

FacilityCityRegionStatus
Medizinische Universität Wien/AKH Wien Vienna Austria
Universitäts-Herzzentrum Freiburg Campus Bad Krozingen Bad Krozingen Baden-Wurttemberg
Universität Tuebingen Tübingen Baden-Wurttemberg
Uniklinikum Ulm Ulm Baden-Wurttemberg
Uniklinikum Erlangen Erlangen Bavaria
Medizinische Klinik I- Campus Grosshadern München Bavaria
Immanuel Klinikum Bernau Bernau bei Berlin Brandenburg
Universitätsklinikum Giessen UKGM Giessen Hesse
Universitaeres Herzzentrum Goettingen Göttingen Lower Saxony
Westdeutsches Herzzentrum / Uniklinik Essen Essen Nordrhine Westfalia
Contilia Herz- und Gefäßzentrum,Elisabeth-Krankenhaus Essen Essen Nordrhine Westfalia
Herz- und Diabeteszentrum NRW - Bad Oeynhausen Bad Oeynhausen North Rhine-Westphalia
Universitätsklinikum Bonn Bonn North Rhine-Westphalia
Herzzentrum Universitaetsklinik Herzzentrum Universitaetsklinik Cologne Cologne North Rhine-Westphalia
St.-Johannes-Hospital Dortmund North Rhine-Westphalia
Universitätsmedizin der Johannes Gutenberg Universität Mainz Mainz North Rhine-Westphalia
Helios Klinikum Siegburg Siegburg North Rhine-Westphalia
Herzzentrum Universitätsklinik Dresden Dresden Saxony
Universitäres Herzzentrum Lübeck, Universitätsklinikum Schleswig-Holstein Lübeck Schleswig-Holstein
Zentralklinik Bad Berka GmbH Bad Berka Germany
Charité Berlin Berlin Germany
Charité Berlin Berlin Germany
MVZ-CCB Frankfurt Germany
Universitares Herzzentrum Hamburg Hamburg Germany
Kath. Marienkrankenhaus Hamburg GmbH Hamburg Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel Kiel Germany
Heart Centre of the University Leipzig Leipzig Germany
Hygeia Hospital Athens Greece
IRCCS Ospedale San Raffaele Milan Lombardy
Ospedale del Cuore G. Pasquinucci Massa Massa Italy
IRCCS Policlinico San Donato San Donato Milanese Italy
St. Antonius Ziekenhuis Nieuwegein Netherlands
Erasmus MC Rotterdam Netherlands
The Cardinal Stefan Wyszyński, Institute of Cardiology Warsaw Poland
Hospital Alvaro Cunqueiro Vigo Spain
Inselspital Bern Bern Switzerland
Wythenshawe Hospital Manchester United Kingdom

More Edwards Lifesciences trials in the UK

The ENCIRCLE Trial Active, not recruiting
Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU) Recruiting
SAPIEN 3 Ultra System PMCF Active, not recruiting
Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve Active, not recruiting

Other trials for the same condition

The ENCIRCLE Trial Active, not recruiting
HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial Recruiting
Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04430075 on ClinicalTrials.gov ↗ ← All trials in the UK