Status:
RECRUITING
Valved Graft PMCF Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Aortic Valve Disease
Ascending Aorta Abnormality
Eligibility:
All Genders
18+ years
Brief Summary
Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.
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
Key Trial Info
Start Date :
July 13 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04754217
Start Date
July 13 2021
End Date
September 1 2029
Last Update
July 16 2025
Active Locations (25)
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1
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States, 35294
2
University of Michigan
Ann Arbor, Michigan, United States, 48104
3
Mission Health & Hospitals
Asheville, North Carolina, United States, 28801
4
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104