CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System

Safety and performance data will be collected to support the commercial use of the ACURATE neo ™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population.

Clinical events as defined per VARC 2 consensus document at procedure: All cause mortality; Stroke; Myocardial Infarction; Bleeding complication; Acute kidney injury; Vascular complication; Conduction disturbances and arrhythmia; Other TAVI-related complications

Time frame: Procedure to Discharge, 30 days and 12-months

Procedural Success

Defined as absence of intra-procedure mortality (procedure to 24H) AND absence of complications arising during implantation of the prosthetic valve such as: inability to properly seat the valve in the annulus; need for more than one implanted aortic bioprosthesis (valve-in-valve or ectopic deployment) or if a surgical aortic valve replacement is required to correct a severe aortic regurgitation or procedure complication. The procedure can be considered as success despite the presence of residual aortic regurgitation, which may be due to the anatomic configuration of the annulus or a calcific valvular annulus.

Time frame: Procedure to 24-hours

Device Success

Defined as; * Absence of intra-procedure mortality (procedure to 24H) AND, * Correct positioning (placement in the annulus with no impairment of aortic bioprosthesis function) of a single prosthetic heart valve into the proper anatomical location AND, * Intended performance of the prosthetic heart valve assessed prior to discharge per local standard of care and defined as: * No prosthesis-patient mismatch (EAOi \>0.85 cm2/m2 or EAOi \>0.7 cm2/m2 for BMI ≥30 kg/m2) ) AND, * Mean aortic valve gradient \<20mmHg or peak velocity \< 3 m/s AND, * No moderate or severe prosthetic valve regurgitation. For echo parameters for the performance assessment, a pre-discharge echo examination should be performed as per local standard of care. If echo parameter pre-discharge is missing, any echo parameter within 45 days post-procedure may be used.

Time frame: Post-procedure to Discharge.

VARC 2 Composite Safety

Defined as: * All-cause mortality * All stroke * Life-threatening bleeding * Acute Kidney Injury- Stage 2 or 3 * Coronary Artery Obstruction requiring intervention * Major Vascular Complications * Valve-related dysfunction requiring repeat procedure

Time frame: 30-days

Functional improvement as per NYHA Functional Classification

Change on NYHA Class between baseline and different follow-up

Time frame: from baseline to, discharge, 30-days and 12-months follow-up.

Improvement of EOA and mean Trans-prosthetic gradient

If the echo parameter pre-discharge is missing to assess the intended performance, any echo parameter data within 45-days post procedure may be used for the missing values;

Time frame: from baseline to discharge, 30- days and 12 months follow-up

Total Aortic Regurgitation

Change on Aortic Regurgitation over time at follow-up

Time frame: post-procedure, prior to discharge, at 30-days and 12-months follow-up;