A prospective, single arm clinical investigation evaluating safety and effectiveness/performance of the Microport CardioFlow VitaFlowTM II – Transcatheter Aortic Valve System for the treatment of symptomatic severe aortic stenosis via transcatheter access in increased surgical risk patients
Sponsor
Primary endpoints
- Rate of all-cause mortality at 12 months post implantation
CERC Services
- CEC and DSMB activities
- CoreLab activities
- Project management
Countries
United Kingdom, Ireland, Denmark
Number of investigational sites
5 centers
