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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Mitral Insufficiency
• Mitral Regurgitation
• Mitral Valve Insufficiency

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