The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico Transcatheter Aortic Heart Valve in patients with symptomatic degenerative aortic stenosis.
The CONFIDENCE registry study will be conducting as a prospective, non-randomized, observational, single-arm, multi-center study.
Approximately 1000 subjects with severe symptomatic (NYHA class II) aortic stenosis (AS), will undergo Portico Transcatheter Aortic Heart Valve implantation.
The subject data will be collected at baseline, index procedure, pre- discharge, 30 days and 12 months from the index procedure.
|Treatment||Portico™ Valve, Delivery System(s) and Loading Systems(s)|
|Clinical Study Identifier||NCT03752866|
|Sponsor||Abbott Medical Devices|
|Last Modified on||12 July 2020|
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