CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System
CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System
The purpose of this registry is to collect specific health and patient data to identify more
 precisely the patient population undergoing TA aortic valve replacement with the ACURATE neo™
 Aortic biprosthesis and ACURATE neo™ TA Transapical Delivery System.

 Safety and efficacy 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.

 As per IFU, the ACURATE neo™ and its ACURATE neo™ TA Delivery System are intended for use in
 minimally invasive, transcatheter aortic valve replacement using transapical access in
 patients presenting with severe aortic valve stenosis.
The Primary Objective of this post-market registry is to collect specific health and patient
 characteristics to understand the indication for TA-TAVI and to further evaluate the safety
 and performance of the ACURATE neo ™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical
 Delivery System in a specific TA population, consisting of 200 consented patients.
Inclusion criteria:

 -  Symptomatic patients with severe aortic stenosis;

 -  Institution heart team determines that aortic valve replacement ACURATE neoTM device
 using its transapical delivery system is appropriate;

 Exclusion criteria:

 - Patients unable or unwilling to give inform consent;