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

Last updated: April 10, 2024
Sponsor: Edwards Lifesciences
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Edwards PASCAL Transcatheter Valve Repair System

Edwards PASCAL Precision Transcatheter Valve Repair System

Clinical Study ID

NCT04614402
2019-11
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient is a candidate for transcatheter tricuspid valve repair as determined by aHeart Team
  2. TR grade ≥3+ (5 grade classification)
  3. Patient is eligible to receive the PASCAL device per the current approved indicationsfor use

Exclusion

Exclusion Criteria:

  1. Tricuspid valve anatomic contraindications, including previous tricuspid valvereplacement
  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 thejudgment of the Investigator
  4. Any patient considered to be part of a vulnerable population

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Edwards PASCAL Transcatheter Valve Repair System
Phase:
Study Start date:
January 15, 2021
Estimated Completion Date:
March 15, 2028

Study Description

The objectives of this clinical study are to collect data on the safety and effectiveness of the PASCAL System and PASCAL Precision System in improving TR, functional status, and quality of life in a post-market setting.

Connect with a study center

  • Universitätsklinikum Ulm Innere Medizin II

    Ulm, Baden-Wuerttemberg 89070
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg Klinik für Kardiologie, Angiologie, Pneumologie

    Heidelberg, Baden-Württemberg 69120
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen Innere Medizin III - Kardiologie und Angiologie

    Tübingen, Baden-Württemberg 72076
    Germany

    Site Not Available

  • Medizinische Klinik I- Campus Grosshadern

    München, Bavaria 81377
    Germany

    Site Not Available

  • Herzzentrum Universitätsklinikum Köln

    Köln, DEU D-50937
    Germany

    Site Not Available

  • Universitätsklinikum Gießen UKGM

    Gießen, Hessen 35392
    Germany

    Site Not Available

  • Westdeutsches Herz- und Gefäßzentrum Klinik für Kardiologie und Angiologie

    Essen, Nordrhine Westfalia 45147
    Germany

    Site Not Available

  • Herz- und Diabeteszentrum NRW - Bad Oeynhausen

    Bad Oeynhausen, North Rhine Westphalia 32545
    Germany

    Site Not Available

  • Herzzentrum der Universitätsklinik Bonn

    Bonn, North Rhine Westphalia 53127
    Germany

    Site Not Available

  • Herzzentrum der Universitätsklinik Bonn

    Nonn, North Rhine Westphalia 53127
    Germany

    Site Not Available

  • Helios Klinikum Siegburg

    Siegburg, North Rhine Westphalia, 53721
    Germany

    Site Not Available

  • Universitätsmedizin der Johannes Gutenberg Universität Mainz

    Mainz, Rhineland-Palatinate 55131
    Germany

    Site Not Available

  • Heart Centre of the University Leipzig

    Leipzig, Saxony 04289
    Germany

    Site Not Available

  • Zentralklinik Bad Berka GmbH

    Bad Berka, Thuringia 99437
    Germany

    Site Not Available

  • Kath. Marienkrankenhaus Hamburg gGmbH

    Hamburg, 22087
    Germany

    Site Not Available

  • UKE Hamburg

    Hamburg, 20246
    Germany

    Site Not Available

  • University Heart Center Lübeck

    Lübeck,
    Germany

    Site Not Available

  • Hygeia Hospital

    Athens, 151 23
    Greece

    Site Not Available

  • Ospedale del Cuore "G. Pasquinucci"

    Massa,
    Italy

    Site Not Available

  • Inselspital

    Bern, 3010
    Switzerland

    Site Not Available

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