VITALE

Brief summary: 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

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  • France and Germany (to be confirmed with Ute as we have withdrawn our applications)

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