Aprospective, single-arm, multi-center, observational, post-market clinical follow-up study, aimed to assess the safety and effectiveness/performance of the self-expanding VitaFlow Liberty™ Transcatheter Aortic Valve System in symptomatic patients with severe aortic stenosis in the post market use.
Study population consists of approximately 122 patients. Patients will be followed-up until 5 years after the procedure.
Sponsor
Study objectives
All-cause mortality and stroke with disability at 12 months post implantation
CERC Services
- Clinical report
- Clinical trial documentation
- CoreLab activities
- Monitoring activities
- Project management
- Safety reporting
- Submission to competent authorities and ethic committees
Countries
Europe (Ireland, Italy, Spain, and other to be confirmed)
