RecruitingNCT04754217

Valved Graft PMCF Study

Valved Graft Post-Market Clinical Follow-up Study


Sponsor

Abbott Medical Devices

Enrollment

260 participants

Start Date

Jul 13, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria1

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

Exclusion Criteria3

  • anticoagulation therapy intolerant
  • active endocarditis
  • anatomical or medical, surgical, psychological or social contraindications

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Interventions

DEVICEVAVGJ

Replacement of the aortic valve and ascending aorta

DEVICECAVGJ

Replacement of the aortic valve and ascending aorta


Locations(25)

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

Birmingham, Alabama, United States

University of Michigan

Ann Arbor, Michigan, United States

Mission Health & Hospitals

Asheville, North Carolina, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Klinik Floridsdorf

Vienna, Austria

Rigshospitalet

Copenhagen, Denmark

CHU de Besancon - Jean Minjoz

Besançon, France

CHRU Lille

Lille, France

Groupe Hospitalier Bichat - Claude Bernard

Paris, France

Herz-und Diabetes Zentrum NRW

Bad Oeynhausen, Germany

Deutsches Herzzentrum Berlin

Berlin, Germany

Klinikum Links der Weser

Bremen, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Onassis Cardiac Surgery Center

Athens, Greece

Policlinico S.Orsola-Malpighi

Bologna, Italy

Ospedale San Raffaele

Milan, Italy

Policlinico San Donato

San Donato Milanese, Italy

Wojewodzki Szpital Zespolony w Kielcach

Kielce, Poland

Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, Poland

Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, Poland

The Cardinal Stefan Wyszynski Institute of Cardiology

Warsaw, Poland

Hospital Universitario del Vinalopó

Elche, Spain

Hospital Universitario Son Espases

Palma de Mallorca, Spain

James Cook University Hospital

Middlesbrough, United Kingdom

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NCT04754217


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