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MiCLASP Post Market Clinical Follow-Up (PMCF) Study

NCT ID: NCT04430075

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-23

Study Completion Date

2031-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mitral Regurgitation Mitral Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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

Transcatheter Valve Repair with Edwards PASCAL and PASCAL Precision System

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Edwards Lifesciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philipp Lurz, Prof.Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Johannes Gutenberg University Mainz

Locations

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Medizinische Universität Wien/AKH Wien

Vienna, , Austria

Site Status ACTIVE_NOT_RECRUITING

Universitäts-Herzzentrum Freiburg Campus Bad Krozingen

Bad Krozingen, Baden-Wurttemberg, Germany

Site Status RECRUITING

Universität Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Site Status RECRUITING

Uniklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Site Status ACTIVE_NOT_RECRUITING

Uniklinikum Erlangen

Erlangen, Bavaria, Germany

Site Status RECRUITING

Medizinische Klinik I- Campus Grosshadern

München, Bavaria, Germany

Site Status RECRUITING

Immanuel Klinikum Bernau

Bernau bei Berlin, Brandenburg, Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Giessen UKGM

Giessen, Hesse, Germany

Site Status RECRUITING

Universitaeres Herzzentrum Goettingen

Göttingen, Lower Saxony, Germany

Site Status ACTIVE_NOT_RECRUITING

Westdeutsches Herzzentrum / Uniklinik Essen

Essen, Nordrhine Westfalia, Germany

Site Status RECRUITING

Contilia Herz- und Gefäßzentrum,Elisabeth-Krankenhaus Essen

Essen, Nordrhine Westfalia, Germany

Site Status RECRUITING

Herz- und Diabeteszentrum NRW - Bad Oeynhausen

Bad Oeynhausen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany

Site Status RECRUITING

Herzzentrum Universitaetsklinik Herzzentrum Universitaetsklinik Cologne

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

St.-Johannes-Hospital

Dortmund, North Rhine-Westphalia, Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsmedizin der Johannes Gutenberg Universität Mainz

Mainz, North Rhine-Westphalia, Germany

Site Status ACTIVE_NOT_RECRUITING

Helios Klinikum Siegburg

Siegburg, North Rhine-Westphalia, Germany

Site Status RECRUITING

Herzzentrum Universitätsklinik Dresden

Dresden, Saxony, Germany

Site Status ACTIVE_NOT_RECRUITING

Universitäres Herzzentrum Lübeck, Universitätsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein, Germany

Site Status RECRUITING

Zentralklinik Bad Berka GmbH

Bad Berka, , Germany

Site Status RECRUITING

Charité Berlin

Berlin, , Germany

Site Status RECRUITING

Charité Berlin

Berlin, , Germany

Site Status ACTIVE_NOT_RECRUITING

MVZ-CCB

Frankfurt, , Germany

Site Status RECRUITING

Universitares Herzzentrum Hamburg

Hamburg, , Germany

Site Status RECRUITING

Kath. Marienkrankenhaus Hamburg GmbH

Hamburg, , Germany

Site Status RECRUITING

Universitätsklinikum Schleswig-Holstein, Campus Kiel

Kiel, , Germany

Site Status RECRUITING

Heart Centre of the University Leipzig

Leipzig, , Germany

Site Status RECRUITING

Hygeia Hospital

Athens, , Greece

Site Status ACTIVE_NOT_RECRUITING

IRCCS Ospedale San Raffaele

Milan, Lombardy, Italy

Site Status ACTIVE_NOT_RECRUITING

Ospedale del Cuore G. Pasquinucci Massa

Massa, , Italy

Site Status ACTIVE_NOT_RECRUITING

IRCCS Policlinico San Donato

San Donato Milanese, , Italy

Site Status ACTIVE_NOT_RECRUITING

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

Site Status ACTIVE_NOT_RECRUITING

Erasmus MC

Rotterdam, , Netherlands

Site Status ACTIVE_NOT_RECRUITING

The Cardinal Stefan Wyszyński, Institute of Cardiology

Warsaw, , Poland

Site Status ACTIVE_NOT_RECRUITING

Hospital Alvaro Cunqueiro

Vigo, , Spain

Site Status ACTIVE_NOT_RECRUITING

Inselspital Bern

Bern, , Switzerland

Site Status ACTIVE_NOT_RECRUITING

Wythenshawe Hospital

Manchester, , United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Countries

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Austria Germany Greece Italy Netherlands Poland Spain Switzerland United Kingdom

Central Contacts

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TMTT Clinical Affairs

Role: CONTACT

[email protected]
+1 (949) 250 ext. 2500

Facility Contacts

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Christian Besler, PD Dr. med.

Role: primary

[email protected]

Tobias Geisler, Prof.Dr.

Role: primary

[email protected]

Silvia Warwas

Role: primary

[email protected]

Jörg Hausleiter, Prof.Dr.

Role: primary

[email protected]

Bernhard Unsoeld, Prof.Dr.

Role: primary

[email protected]

Tienush Rassaf, Prof.Dr.

Role: primary

[email protected]

Thomas Schmitz, Dr.

Role: primary

[email protected]

Volker Rudolph, Prof.Dr.

Role: primary

[email protected]

Georg Nickenig, Prof.Dr.

Role: primary

[email protected]

Stephan Baldus, Prof.Dr.

Role: primary

[email protected]

Peter Boekstegers, Prof.Dr.

Role: primary

[email protected]

Ingo Eitel, Prof.Dr.

Role: primary

[email protected]

Harald Lapp, Prof. Dr. med.

Role: primary

[email protected]

Markus Reinthaler, Dr.

Role: primary

[email protected]

Claudia Walther, Dr. med.

Role: primary

[email protected]

Niklas Schofer, Dr. med.

Role: primary

[email protected]

Edith Lubos, Dr.

Role: primary

[email protected]

Derk Frank, Prof. Dr. med.

Role: primary

[email protected]

Tobias Kister, Dr.

Role: primary

[email protected]

Other Identifiers

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2018-08

Identifier Type: -

Identifier Source: org_study_id

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