No formal sample size calculation was conducted. Data were analysed according to the Intention-to-Treat population, which included all patients in whom an implant was attempted. Patients who received a prosthesis other than the study valve (e.g. conversion to open heart, valve-in-valve) were excluded from echocardiographic follow-up, but included in safety assessments. Data are presented using descriptive statistical methods. For quantitative variables, means and standard deviations (SD) were calculated, and for categorical data absolute and relative frequencies. When appropriate, 95% CIs were calculated. Event estimates were calculated using the Kaplan–Meier method; the log-rank test was used to compare overall mortality. Cox proportional hazards regression analysis was used to explore the association between SAVI-1 and SAVI-2. Data analysis was performed using SAS V9.3 (SAS Institute Cary, NC, USA).