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NCT04430075 Clinical Trial

MiCLASP Post Market Clinical Follow-Up (PMCF) Study

Mitral Regurgitation Clinical Trial

— MiCLASP  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04430075
Other study ID # 2018-08
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 23, 2019
Est. completion date April 30, 2030

Study information
Verified date February 2024
Source Edwards Lifesciences
Contact TMTT Clinical Affairs
Phone +1 (949) 250
Email TMTT_Clinical@edwards.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date April 30, 2030
Est. primary completion date February 28, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

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

Sponsors (1)
Lead Sponsor Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Austria,  Germany,  Greece,  Italy,  Netherlands,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
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Completed NCT05836532 - Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
Recruiting NCT03975998 - Dutch-AMR: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Mitral Regurgitation
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