Table 1 Registry objectives

Secondary objectives

Mortality

To determine all-cause, cardiac- and valve-related mortality in the overall study population and in different patient subgroups at all timepoints:

• Chronic kidney disease

• Diabetes

• Hypertension

• Metabolic syndrome

• Chronic inflammation

Hemodynamic performance and durability

• Hemodynamic performance of the INSPIRIS RESILIA Aortic Valve™ in the overall study population and stratified according to the different patient subgroups including patient prosthesis mismatch (PPM) including maximum (Pmax) and mean (Pmean) pressure gradient across the valve, Velocity Time Integral (VTI), Prosthesis Opening Area (EOA), Left Ventricular ejection fraction (LVEF), Paravalvular Leak

• Severe hemodynamic structural valve deterioration (SVD) following Salaun [19]

• Description of potential ViV procedures* and clinical outcome including follow-up

Clinical outcomes (overall study population and stratified according to the different patient subgroups)

• NYHA functional class compared to baseline

• Freedom from valve-related rehospitalization

• New pacemaker implantation

• Freedom from valve-related complications

Exploratory endpoints

Safety (defined according to VARC-2)

• SVD

• Non-structural valve deterioration

• Thromboembolic events (e.g., stroke)

• Valve thrombosis

• All bleeding/hemorrhage

• Major bleeding/hemorrhage

• All paravalvular leakage

• Endocarditis

• All-cause mortality

• Cardiac-related mortality

• Valve-related mortality

• Re-intervention

• Conduction disturbances