Observational Study of Abbott Valved Grafts for Aortic Valve Disease

This is an observational study looking at how well two types of Abbott Valved Grafts (VAVGJ and CAVGJ) work when used to replace your aortic valve and part of your ascending aorta (the main artery leaving your heart). You might be able to join if you are 18 or older and are having heart surgery to implant one of these grafts for a native or prosthetic valve replacement. However, you cannot participate if you can't tolerate blood thinners, have an active heart infection (endocarditis), or have other medical or social reasons that make the study unsuitable. The study will track how many people pass away and how many need another surgery over five years. The current recruitment status is unclear.

Study design
This is a global, multi-center observational study that will follow 260 participants. It is not randomized, meaning participants are not assigned to different treatment groups by chance.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for five years to track outcomes like mortality and the need for additional surgery.

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NCT04754217

Valved Graft PMCF Study

Recruiting
Not specifiedAges 18+Observational
Abbott Medical Devices
~260 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:VAVGJCAVGJ

At a glance

Recruiting sites
21 of 25 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
annualized event rate of all-cause mortality
Measured over 5 Years
+1 more outcome measured
Aortic Valve Disease
Ascending Aorta Abnormality
Aortic Dissection
25 sites across 13 states
Germany4
Poland4
France3
Italy3
Pennsylvania2
Spain2
Alabama1
Michigan1

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Eligibility criteria

Inclusion

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

Exclusion

anticoagulation therapy intolerant
active endocarditis
anatomical or medical, surgical, psychological or social contraindications
  • annualized event rate of all-cause mortality5 Years

    Primary Safety Endpoint

  • annualized event rate of reintervention5 Years

    Primary Effectiveness Endpoint