Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System
NCT ID: NCT04614402
Last Updated: 2025-07-02
Study Results
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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ACTIVE_NOT_RECRUITING
300 participants
OBSERVATIONAL
2021-01-15
2028-03-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Edwards PASCAL Transcatheter Valve Repair System
The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.
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.
Eligibility Criteria
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Inclusion Criteria
2. TR grade ≥3+ (5 grade classification)
3. Patient is eligible to receive the PASCAL device per the current approved indications for use
Exclusion Criteria
2. Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation
3. Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
4. Any patient considered to be part of a vulnerable population
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Stephan Baldus, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Herzzentrum Uniklinik Köln, Klinik III für lnnere Medizin
Locations
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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
Countries
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Other Identifiers
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2019-11
Identifier Type: -
Identifier Source: org_study_id
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