Valved Graft PMCF Study

Last updated: August 6, 2024
Sponsor: Abbott Medical Devices
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Heart Valve Disease

Occlusions

Treatment

VAVGJ

CAVGJ

Clinical Study ID

NCT04754217
ABT-CIP-10386
  • Ages > 18
  • All Genders

Study Summary

Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • cardiac surgery including the implant of a VAVGJ or CAVGJ for native or prostheticvalve replacement

Exclusion

Exclusion Criteria:

  • anticoagulation therapy intolerant

  • active endocarditis

  • anatomical or medical, surgical, psychological or social contraindications

Study Design

Total Participants: 260
Treatment Group(s): 2
Primary Treatment: VAVGJ
Phase:
Study Start date:
July 13, 2021
Estimated Completion Date:
September 30, 2029

Connect with a study center

  • Klinik Floridsdorf

    Vienna, 1012
    Austria

    Active - Recruiting

  • Rigshospitalet

    Copenhagen, 2100
    Denmark

    Active - Recruiting

  • CHU de Besancon - Jean Minjoz

    Besançon, 25030
    France

    Active - Recruiting

  • CHRU Lille

    Lille, 59037
    France

    Active - Recruiting

  • Groupe Hospitalier Bichat - Claude Bernard

    Paris, 75877
    France

    Active - Recruiting

  • Herz-und Diabetes Zentrum NRW

    Bad Oeynhausen, 32545
    Germany

    Active - Recruiting

  • Deutsches Herzzentrum Berlin

    Berlin, 13353
    Germany

    Active - Recruiting

  • Klinikum Links der Weser

    Bremen, 28277
    Germany

    Active - Recruiting

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Active - Recruiting

  • Onassis Cardiac Surgery Center

    Athens, 17674
    Greece

    Active - Recruiting

  • Policlinico S.Orsola-Malpighi

    Bologna, 40138
    Italy

    Active - Recruiting

  • Ospedale San Raffaele

    Milan, 20132
    Italy

    Active - Recruiting

  • Policlinico San Donato

    San Donato Milanese, 20097
    Italy

    Active - Recruiting

  • Wojewodzki Szpital Zespolony w Kielcach

    Kielce, 25-736
    Poland

    Site Not Available

  • Krakowski Szpital Specjalistyczny im. Jana Pawla II

    Krakow, 31-202
    Poland

    Active - Recruiting

  • The Cardinal Stefan Wyszynski Institute of Cardiology

    Warsaw, 04-628
    Poland

    Active - Recruiting

  • Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

    Łódź, 92-213
    Poland

    Site Not Available

  • Hospital Universitario del Vinalopó

    Elche, 03293
    Spain

    Active - Recruiting

  • Hospital Universitario Son Espases

    Palma De Mallorca, 07120
    Spain

    Active - Recruiting

  • James Cook University Hospital

    Middlesbrough, TS43BW
    United Kingdom

    Active - Recruiting

  • University Hospital - Univ. of Alabama at Birmingham (UAB)

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48104
    United States

    Active - Recruiting

  • Mission Health & Hospitals

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

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