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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.
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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.
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Candidates will be excluded if any of the following conditions are present:
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1,001 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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