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Clinical Trials in the UK / NCT04754217
Recruiting Observational

Valved Graft PMCF Study

NCT04754217 · tracked via the Priya Life Science UK tracker
Sponsor
Abbott Medical Devices
Phase
Observational
Started
2021-07-13
Last updated
2026-04-13

Condition(s) studied

Aortic Valve DiseaseAscending Aorta AbnormalityAortic Dissection

Investigational drug(s) / intervention(s)

VAVGJCAVGJ

VAVGJ: Replacement of the aortic valve and ascending aorta

CAVGJ: Replacement of the aortic valve and ascending aorta

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • annualized event rate of all-cause mortality — 5 Years
    Primary Safety Endpoint
  • annualized event rate of reintervention — 5 Years
    Primary Effectiveness Endpoint

Trial sites (25)

FacilityCityRegionStatus
University Hospital - Univ. of Alabama at Birmingham (UAB) Birmingham Alabama Withdrawn
University of Michigan Ann Arbor Michigan Recruiting
Mission Health & Hospitals Asheville North Carolina Withdrawn
Hospital of the University of Pennsylvania Philadelphia Pennsylvania Recruiting
University of Pittsburgh Medical Center Pittsburgh Pennsylvania Recruiting
Klinik Floridsdorf Vienna Austria Recruiting
Rigshospitalet Copenhagen Denmark Recruiting
CHU de Besancon - Jean Minjoz Besançon France Recruiting
CHRU Lille Lille France Recruiting
Groupe Hospitalier Bichat - Claude Bernard Paris France Recruiting
Herz-und Diabetes Zentrum NRW Bad Oeynhausen Germany Recruiting
Deutsches Herzzentrum Berlin Berlin Germany Recruiting
Klinikum Links der Weser Bremen Germany Recruiting
Medizinische Hochschule Hannover Hanover Germany Recruiting
Onassis Cardiac Surgery Center Athens Greece Recruiting
Policlinico S.Orsola-Malpighi Bologna Italy Recruiting
Ospedale San Raffaele Milan Italy Recruiting
Policlinico San Donato San Donato Milanese Italy Recruiting
Wojewodzki Szpital Zespolony w Kielcach Kielce Poland Withdrawn
Krakowski Szpital Specjalistyczny im. Jana Pawla II Krakow Poland Recruiting
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi Lodz Poland Active Not Recruiting
The Cardinal Stefan Wyszynski Institute of Cardiology Warsaw Poland Recruiting
Hospital Universitario del Vinalopó Elche Spain Recruiting
Hospital Universitario Son Espases Palma de Mallorca Spain Recruiting
James Cook University Hospital Middlesbrough United Kingdom Recruiting

More Abbott Medical Devices trials in the UK

Post-Market Clinical Follow Up Study With Navitor Valve Recruiting
Abbott Structural Heart Device Registry Recruiting
Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator Recruiting
Portico Next Generation Approval Study Active, not recruiting
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation Enrolling by invitation

Other trials for the same condition

ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation Enrolling by invitation
Thoraflex Hybrid and Relay Extension Post-Approval Study Active, not recruiting
Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04754217 on ClinicalTrials.gov ↗ ← All trials in the UK