NCT04754217Recruiting

Valved Graft PMCF Study

Abbott Medical Devices

Start Date

7/13/2021

Completion Date

9/1/2029

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * cardiac surgery including the implant of a VAVGJ or CAVGJ for native or prosthetic valve replacement Exclusion Criteria: * anticoagulation therapy intolerant * active endocarditis * anatomical or medical, surgical, psychological or social contraindications

Interventions

DEVICE

VAVGJ

DEVICE

CAVGJ

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Aortic Valve DiseaseAscending Aorta AbnormalityAortic Dissection

Locations

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

Birmingham, Alabama 35294

United States

University of Michigan

Ann Arbor, Michigan 48104

United States

Mission Health & Hospitals

Asheville, North Carolina 28801

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15213

United States

Klinik Floridsdorf

Vienna, 1012

Austria

Rigshospitalet

Copenhagen, 2100

Denmark

CHU de Besancon - Jean Minjoz

Besançon, 25030

France

CHRU Lille

Lille, 59037

France

Groupe Hospitalier Bichat - Claude Bernard

Paris, 75877

France

Herz-und Diabetes Zentrum NRW

Bad Oeynhausen, 32545

Germany

Deutsches Herzzentrum Berlin

Berlin, 13353

Germany

Klinikum Links der Weser

Bremen, 28277

Germany

Medizinische Hochschule Hannover

Hanover, 30625

Germany

Onassis Cardiac Surgery Center

Athens, 17674

Greece

Policlinico S.Orsola-Malpighi

Bologna, 40138

Italy

Ospedale San Raffaele

Milan, 20132

Italy

Policlinico San Donato

San Donato Milanese, 20097

Italy

Wojewodzki Szpital Zespolony w Kielcach

Kielce, 25-736

Poland

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, 31-202

Poland

Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, 92-213

Poland

The Cardinal Stefan Wyszynski Institute of Cardiology

Warsaw, 04-628

Poland

Hospital Universitario del Vinalopó

Elche, 03293

Spain

Hospital Universitario Son Espases

Palma de Mallorca, 07120

Spain

James Cook University Hospital

Middlesbrough, TS43BW

United Kingdom