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RecruitingNCT04754217Updated Apr 13, 2026

Valved Graft PMCF Study

An observational study in Aortic Valve Disease, Ascending Aorta Abnormality and Aortic Dissection, sponsored by Abbott Medical Devices. Recruiting at 25 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Abbott Medical Devices (part of Abbott) · Observational

From the registry’s dates

  • Started Jul 2021; still recruiting 5 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
260
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Aortic Valve Disease
  • Ascending Aorta Abnormality
  • Aortic Dissection

Keywords

  • Aortic Root Replacement
  • Ascending Aorta Replacement
  • Valved Graft
  • CAVGJ
  • VAVGJ
03

In context

Aortic Valve Disease

234 studies on the registry are indexed under Aortic Valve Disease; 70 are open to participants now.

This study's planned enrollment of 260 is above the median of 200 across 106 observational studies indexed under Aortic Valve Disease.

Browse Aortic Valve Disease studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.

Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.

Browse Abbott Medical Devices studies →All Abbott studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • anticoagulation therapy intolerant
  • active endocarditis
  • anatomical or medical, surgical, psychological or social
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
260 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group 1

    VAVGJ

    Device: VAVGJ

  • Group 2

    CAVGJ

    Device: CAVGJ

Interventions

  • DeviceVAVGJ

    Replacement of the aortic valve and ascending aorta

  • DeviceCAVGJ

    Replacement of the aortic valve and ascending aorta

06

What researchers measure

Primary outcomes

  1. annualized event rate of all-cause mortality

    Primary Safety Endpoint

    Time frame: 5 Years

  2. annualized event rate of reintervention

    Primary Effectiveness Endpoint

    Time frame: 5 Years

07

Study locations

21 of 25 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2021 (actual). Primary completion is estimated for Jul 2029, 96 months after the start.

Of 56 observational studies under Aortic Valve Disease, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 97. This study's planned 96 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 10, 2021
First posted
Feb 15, 2021
StartActual
Jul 13, 2021
Primary completionEst.
Jul 2029
CompletionEst.
Sep 2029
Last update
Apr 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04754217
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Feb 15, 2021
Start date
Jul 13, 2021
Primary completion
Jul 2029 (estimated)
Completion
Sep 2029 (estimated)
Last update
Apr 13, 2026

Study contacts

Paolo Amato
Contact
paolo.amato@abbott.com
+39 335 61 40 573
Karine Miquel
Contact
karine.miquel@abbott.com
+32 479 60 01 07

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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