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