Symptomatic Aortic Stenosis Clinical Trial
Official title:
A Two -Stage First in Human (FIH) Feasibility / Pivotal Study of the Vienna Aortic Valve SE System
This is a prospective, single arm, multicenter study in an expanding cohort of 150 symptomatic patients with severe aortic stenosis who will be followed up for up to 5 years.
The purpose of this trial is to determine the safety and effectiveness of the Vienna Aortic Valve SE System, a new self-expanding transcatheter heart valve, in patients with symptomatic severe aortic stenosis (SSAS). This is a prospective, single arm, multicenter study in an expanding cohort of symptomatic patients with severe aortic stenosis following the FIH feasibility study. The clinical investigation comprises 11 visits (V1 to V11). After implantation of the IMD at visit 2, safety and effectiveness assessment of the device will be performed at 30 days (V4), 3 months (V5), 6 months (V6), 1 year (V7) and every year thereafter up to 5 years post-implantation (V8 to V11). In summary, the clinical investigation for the individual patient will end after 5 years with a full clinical evaluation. The primary study endpoints for safety and effectiveness will be reached at 30-day follow-up timepoint. The clinical trial is completed after all 150 patients (including 10 patients from FIH study), that are not prematurely withdrawn, have completed their 5-year follow-up visit involving all specified assessments. ;
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