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
- Are there results?
- Not yet: the study is under way
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- Withdrawn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- Withdrawn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- Withdrawn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
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valved Graft Post-Market Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT04754217
- Acronym / sponsor ID
- ABT-CIP-10386
- Keywords
- Aortic Root Replacement, Ascending Aorta Replacement, Valved Graft, CAVGJ, VAVGJ
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: VAVGJVAVGJ |
| Group 2 | – | Device: CAVGJCAVGJ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- cardiac surgery including the implant of a VAVGJ or CAVGJ for native or prosthetic valve replacement
Key exclusion criteria (3 listed)
- anticoagulation therapy intolerant
- active endocarditis
- anatomical or medical, surgical, psychological or social contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VAVGJReplacement of the aortic valve and ascending aorta | Device | Group 1 |
| CAVGJReplacement of the aortic valve and ascending aorta | Device | Group 2 |
Primary outcome
annualized event rate of all-cause mortality
Time frame: 5 Years
Primary Safety Endpoint
annualized event rate of reintervention
Time frame: 5 Years
Primary Effectiveness Endpoint
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
25 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease and Ascending Aorta Abnormality, run by Abbott Medical Devices at 25 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Germany, Poland, France, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paolo Amato (+39 335 61 40 573, paolo.amato@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
annualized event rate of all-cause mortality (time frame: 5 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.