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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Valved Graft PMCF Study
At a glance
Conditions
Where it's being run
25 sites across 13 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- annualized event rate of all-cause mortality5 Years
Primary Safety Endpoint
- annualized event rate of reintervention5 Years
Primary Effectiveness Endpoint