SAVI TF 1000 Registry1

Symetis ACURATE neoValve Implantation using TransFemoral Access

Study Design

  • Post-market registry, 1000 patients
  • October 2014 – April 2016; 25 EU sites

Endpoints

  • Primary
    • All cause mortality @ 30 Days
  • Secondary
    • Procedure success
    • Device performance @ 7 days and 12 months
    • VARC 2 safety @ 30 days and 12 months
    • NYHA Class @ 30 days and 12 months