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

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)

Facility	City	Region
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

SAPIEN 3 Ultra System PMCF Active, not recruiting

Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve Active, not recruiting

The ENCIRCLE Trial Recruiting

Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU) Recruiting

Other trials for the same condition

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

The ENCIRCLE Trial 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

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