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First-in-Human clinical investigation to evaluate the safety and clinical performance of the BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis, which are as judged by the heart team, indicated for transfemoral transcatheter aortic valve implantation
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In a non-randomized, prospective, multi-center clinical investigation, approximately 86 eligible subjects will be enrolled.
Phase 1: BIOVALVE-I feasibility clinical investigation: Approximately 13 eligible subjects will be enrolled.
Phase 2: BIOVALVE-II pilot clinical investigation: Approximately 73 eligible subjects will be enrolled.
BIOVALVE-I/II subjects follow the same clinical investigation plan (CIP) in all aspects.
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68 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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