Prospective, multi-center, non-randomized interventional study to evaluate the safety, effectiveness and performance of the Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis.
150 subjects will be enrolled in up to 20 sites in multiple countries/regions including Europe, North America, and Asia.
Clinical visits will be scheduled at screening, pre-discharge, 30 days, 6 months, 12 months, and annually thereafter to 5 years.
Sponsor
Study objectives
To evaluate the safety, effectiveness and performance of the Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis.
Primary endpoints
- 1. Primary Safety: All-cause mortality at 1 year
- 2. Primary Effectiveness: Acceptable bioprosthesis function at 30 days by echocardiogram
Countries
Multiple countries/regions including Europe, North America and Asia
Number of investigational sites
Up to 20 sites in total
