Valved Graft PMCF Study

Recruiting now

Conditions studied: Aortic Valve Disease, Ascending Aorta Abnormality, Aortic Dissection

In brief

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

Key facts

Study ID

NCT04754217

Run by

Abbott Medical Devices

People needed

260

Starts

2021-07-13

Expected to finish

2029-09-01

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• James Cook University Hospital — Middlesbrough, United Kingdom (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Krakowski Szpital Specjalistyczny im. Jana Pawla II — Krakow, Poland (enrolling)
• The Cardinal Stefan Wyszynski Institute of Cardiology — Warsaw, Poland (enrolling)
• Hospital Universitario del Vinalopó — Elche, Spain (enrolling)
• Hospital Universitario Son Espases — Palma de Mallorca, Spain (enrolling)
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Klinik Floridsdorf — Vienna, Austria (enrolling)
• Rigshospitalet — Copenhagen, Denmark (enrolling)
• CHU de Besancon - Jean Minjoz — Besançon, France (enrolling)
• CHRU Lille — Lille, France (enrolling)
• Groupe Hospitalier Bichat - Claude Bernard — Paris, France (enrolling)
• Herz-und Diabetes Zentrum NRW — Bad Oeynhausen, Germany (enrolling)
• Deutsches Herzzentrum Berlin — Berlin, Germany (enrolling)
• Klinikum Links der Weser — Bremen, Germany (enrolling)
• Medizinische Hochschule Hannover — Hanover, Germany (enrolling)
• Onassis Cardiac Surgery Center — Athens, Greece (enrolling)
• Policlinico S.Orsola-Malpighi — Bologna, Italy (enrolling)
• Ospedale San Raffaele — Milan, Italy (enrolling)
• Policlinico San Donato — San Donato Milanese, Italy (enrolling)
• Mission Health & Hospitals — Asheville, North Carolina, United States
• Wojewodzki Szpital Zespolony w Kielcach — Kielce, Poland
• University Hospital - Univ. of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States
• Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi — Lodz, Poland

Full record on ClinicalTrials.gov

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