Inspiris Resilia Durability Registry
This trial has no sites in United States.
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Trial details
- Who runs it
- Institut für Pharmakologie und Präventive Medizin
- Trial code
- NCT03666741
- Record updated
- 15 June 2025
- Original description
Prospective, open-label, multicenter, European registry with a follow-up of 5 years to assess the clinical outcomes of patients younger than 60 years who undergo surgical AVR with the INSPIRIS RESILIA Aortic Valve™.Read full original descriptionShow less
Clinical Outcomes of Patients Under the Age of Sixty Undergoing INSPIRIS RESILIA Aortic Valve Replacement
Prospective, open-label, multicenter, European registry with a follow-up of 5 years to assess the clinical outcomes of patients younger than 60 years who undergo surgical AVR with the INSPIRIS RESILIA Aortic Valve™.
Inclusion: Age 18 to 60 years inclusive; Subject requiring a planned replacement of their native aortic valve as indicated in a preoperative evaluation; Subject is scheduled to undergo planned aortic valve replacement with or without concomitant root replacement and/or coronary bypass surgery; Subject is scheduled to attend yearly follow-up visits at the registry center up to 5 years follow-up; Subject provides written informed consent prior to the procedure.
Exclusion: Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery; Previous aortic valve replacement; Valve implantation is not possible in accordance with the device IFU; Subject has a life expectancy ≤ 12 months for any reason; Intraoperative Exclusion criteria:; Valve implantation is not possible in accordance with the device IFU.