PROVE ACURATE neo2TM - post market safety and performance surveillance in aorticstenosis

01/06/2023 to 31/12/2026

Objective: To further evaluate the safety, efficacy and device performance of the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system in 2000 consecutive patients with severe aortic stenosis according to VARC-3 criteria.
Primary Endpoint: All-cause mortality up to 12 months follow-up
Secondary Endpoint: Clinical endpoints according to VARC-3 at the respective time points: mortality, neurologic events, myocardial infarction, re-hospitalization, bleeding and transfusions, vascular and access-related complications, cardiac structural complications, other procedural or valve-related complications, new conduction disturbance and arrhythmia, acute kidney injury, bioprosthetic valve dysfunction, clinically significant valve thrombosis, and patient-reported outcomes and health status (Kansas City Cardiomyopathy Questionnaire)