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ACTIVE NOT RECRUITING
NCT04614402

Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System

Sponsor: Edwards Lifesciences

View on ClinicalTrials.gov

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 tricuspid valve repair.

Official title: Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post-Market Clinical Follow up

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2021-01-15

Completion Date

2028-03-15

Last Updated

2025-07-02

Healthy Volunteers

No

Interventions

DEVICE

Edwards PASCAL Transcatheter Valve Repair System

The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.

DEVICE

Edwards PASCAL Precision Transcatheter Valve Repair System

The Edwards PASCAL Precision Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.

Locations (15)

Universitätsklinikum Tübingen Innere Medizin III - Kardiologie und Angiologie

Tübingen, Baden-Wurttemberg, Germany

Universitätsklinikum Ulm Innere Medizin II

Ulm, Baden-Wurttemberg, Germany

Medizinische Klinik I- Campus Grosshadern

München, Bavaria, Germany

Herzzentrum Universitätsklinikum Köln

Cologne, DEU, Germany

Westdeutsches Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie

Essen, Nordrhine Westfalia, Germany

Herz- und Diabeteszentrum NRW - Bad Oeynhausen

Bad Oeynhausen, North Rhine-Westphalia, Germany

Herzzentrum der Universitätsklinik Bonn

Bonn, North Rhine-Westphalia, Germany

Heart Centre of the University Leipzig

Leipzig, Saxony, Germany

Zentralklinik Bad Berka GmbH

Bad Berka, Thuringia, Germany

UKE Hamburg

Hamburg, Germany

Kath. Marienkrankenhaus Hamburg gGmbH

Hamburg, Germany

University Heart Center Lübeck

Lübeck, Germany

Hygeia Hospital

Athens, Greece

Ospedale del Cuore "G. Pasquinucci"

Massa, Italy

Inselspital

Bern, Switzerland