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Valved Graft PMCF Study
RecruitingObservational study
Valved Graft Post-Market Clinical Follow-up Study
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * cardiac surgery including the implant of a VAVGJ or CAVGJ for native or prosthetic valve replacement Exclusion Criteria: * anticoagulation therapy intolerant * active endocarditis * anatomical or medical, surgical, psychological or social contraindications
About the study
Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.
What is being tested
- VAVGJ (device)
- CAVGJ (device)
Sponsor: Abbott Medical Devices · Participants: 260 · Started: Jul 13, 2021
Contact the study team
- Paolo Amato · Phone: +39 335 61 40 573
- Karine Miquel · Phone: +32 479 60 01 07
Official record on ClinicalTrials.gov — NCT04754217
Locations in the U.S.
| Michigan | University of Michigan, Ann Arbor |
| Pennsylvania | Hospital of the University of Pennsylvania, Philadelphia University of Pittsburgh Medical Center, Pittsburgh |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.