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

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)

Facility	City	Region	Status
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 of Alabama at Birmingham (UAB)	Birmingham	Alabama	Withdrawn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Mission Health & Hospitals	Asheville	North Carolina	Withdrawn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Wojewodzki Szpital Zespolony w Kielcach	Kielce	Poland	Withdrawn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

PARADIGM: Amplatzer Valvular Plug for PVL Closure Active, not recruiting

Amplatzer Amulet LAAO vs. NOAC Active, not recruiting

Abbott DBS Post-Market Study of Outcomes for Indications Over Time Recruiting

Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation Active, not recruiting

Portico Next Generation Approval Study Active, not recruiting

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