RESPOND POST MARKET STUDY

A prospective, single arm, multi-center, observational post market study designed to collect real world clinical and device performance outcomes data of the commercially available Lotus Valve used in routine clinical practice.

  • 1014 patients enrolled: 41 centers in Europe, Asia-Pacific, and Latin America  
  • Available valve sizes: 23mm, 25mm, & 27mm  
  • Primary Endpoint: All-cause mortality at 30 days and 1 year post-implantation  
  • Key Secondary Endpoint: Grade of paravalvular aortic valve regurgitation pre-discharge
  • Clinical endpoints at 30 days: Defined according to VARC 2 guidelines

       

RESPOND Post Market Study – Results 250 Patients Interim Results at 1 year1