Aortic Valve DiseaseNCT04754217
Valved Graft PMCF Study
An observational study of Aortic Valve Disease and Ascending Aorta Abnormality, run by Abbott Medical Devices at 25 sites in 10 countries.
Trial summary
Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease, Ascending Aorta Abnormality, Aortic Dissection
- What is being tested?
- VAVGJ and CAVGJ
- Type of treatment
- Medical device
- How many people
- 260 participants
- Where
- 25 sitesin 10 countries
- Study dates
- 13 Jul 2021to Sep 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll male and female subjects who will be undergoing replacement of a native or prosthetic aortic heart valve and ascending aorta.
Who may be able to join
- cardiac surgery including the implant of a VAVGJ or CAVGJ for native or prosthetic valve replacement
Who cannot join
- anticoagulation therapy intolerant
- active endocarditis
- anatomical or medical, surgical, psychological or social contraindications
Trial locations and contacts
25 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
25 sites in 10 countries
United States5 sites, 3 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48104
- Withdrawn
Mission Health & Hospitals
Asheville, North Carolina, 28801
- Withdrawn
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35294
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Germany4 sites, 4 recruiting
- Recruiting
Herz-und Diabetes Zentrum NRW
Bad Oeynhausen, 32545
- Recruiting
Deutsches Herzzentrum Berlin
Berlin, 13353
- Recruiting
Klinikum Links der Weser
Bremen, 28277
- Recruiting
Medizinische Hochschule Hannover
Hanover, 30625
Poland4 sites, 2 recruiting
- Withdrawn
Wojewodzki Szpital Zespolony w Kielcach
Kielce, 25-736
- Recruiting
Krakowski Szpital Specjalistyczny im. Jana Pawla II
Krakow, 31-202
- Active, not recruiting
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz, 92-213
- Recruiting
The Cardinal Stefan Wyszynski Institute of Cardiology
Warsaw, 04-628
France3 sites, 3 recruiting
- Recruiting
CHU de Besancon - Jean Minjoz
Besançon, 25030
- Recruiting
CHRU Lille
Lille, 59037
- Recruiting
Groupe Hospitalier Bichat - Claude Bernard
Paris, 75877
Italy3 sites, 3 recruiting
- Recruiting
Policlinico S.Orsola-Malpighi
Bologna, 40138
- Recruiting
Ospedale San Raffaele
Milan, 20132
- Recruiting
Policlinico San Donato
San Donato Milanese, 20097
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario del Vinalopó
Elche, 03293
- Recruiting
Hospital Universitario Son Espases
Palma de Mallorca, 07120
Greece1 site, 1 recruiting
- Recruiting
Onassis Cardiac Surgery Center
Athens, 17674
United Kingdom1 site, 1 recruiting
- Recruiting
James Cook University Hospital
Middlesbrough, TS43BW
About this study
Official title: Valved Graft Post-Market Clinical Follow-up Study
Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.
- Being tested
- VAVGJ, CAVGJ
- Keywords
- Aortic Root Replacement, Ascending Aorta Replacement, Valved Graft, CAVGJ, VAVGJ
- Medical subject headings
- Aortic Valve Disease, Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAVGJDevice
Replacement of the aortic valve and ascending aorta
CAVGJDevice
Replacement of the aortic valve and ascending aorta
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | VAVGJ Receives: Device: VAVGJ | |
| Group 2 | CAVGJ Receives: Device: CAVGJ |
What is being measured
The primary outcome is the main question the study is designed to answer.
annualized event rate of all-cause mortality
Primary Safety Endpoint
Measured: 5 Years
annualized event rate of reintervention
Primary Effectiveness Endpoint
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start13 Jul 2021
- Primary completionJul 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754217
- Sponsor's protocol ID
- ABT-CIP-10386
- Status last verified
- Apr 2026
- First submitted
- 10 Feb 2021
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No