Brief summary

A prospective, single arm clinical investigation evaluating safety and effectiveness/performance of the Microport CardioFlow VitaFlow^TM II – Transcatheter Aortic Valve System for the treatment of symptomatic severe aortic stenosis via transcatheter access in increased surgical risk patients

Primary endpoints

Rate of all-cause mortality at 12 months post implantation

CERC Services

Corelab, Care Review Committee meetings, Data Management, CEC, DSMB, Project Management (without monitoring and site follow up)

Countries

United Kingdom, Ireland, Denmark, Switzerland, Netherlands (Submissions ongoing),

• France and Germany

Center number

5 centers active, sites to be initiated in Switzerland and Netherlands