The study consists of 7 visits spread out across two phases over 1 year. The clinical investigation will end at 30 days post-implantation. The subsequent 3-month, 6-month and 1-year follow-up (FU) visits will thus be considered post-market clinical follow-up (PMCF).~The FIH study will start by evaluating the safety and feasibility of the device and study design of the Vienna Aortic Valve SE System in 10 patients with SSAS. The FIH patients must meet all study eligibility criteria. Safety and feasibility assessments for patients in the FIH period will include implantation success, hemodynamic performance and monitoring of adverse events (AEs). Early FIH data (i.e. data from the first 10 patients to have completed visit 3 at hospital discharge) will be provided to the Data and Safety Monitoring Board (DSMB) for review during which study enrollment will be paused. After reviewing the safety results from the FIH study, the DSMB will make a recommendation on whether the study may continue as planned. FIH patients will continue to be followed up for 1 year as per protocol. Data from the 10 FIH patients and the subsequent 75 patients will be analyzed together for the pivotal study endpoints.~Upon a decision from the DSMB to proceed with the study, enrolment of patients will resume.~The clinical investigation phase comprises 4 visits (V1 to V4). After implantation of the IMD at visit 2, early performance and safety assessment of the device will be performed at 30 days (V4). The post-market surveillance phase comprises 3 visits (V5-V7), extending from 3 months to 1 year post-implantation, to evaluate the long-term safety and performance profile of the device.
This is a prospective, non-randomized, single arm, multicenter, multinational two-stage FIH feasibility followed by pivotal study in symptomatic patients with severe aortic stenosis.