ProjectPROVE ACURATE neo2TM - post market safety and performance surveillance in aorticstenosis
Basic data
Title:
PROVE ACURATE neo2TM - post market safety and performance surveillance in aorticstenosis
Duration:
01/06/2023 to 31/12/2026
Abstract / short description:
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)
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)
Involved staff
Managers
Department of Internal Medicine
Hospitals and clinical institutes, Faculty of Medicine
Hospitals and clinical institutes, Faculty of Medicine
Contact persons
Faculty of Medicine
University of Tübingen
University of Tübingen
Other staff
Faculty of Medicine
University of Tübingen
University of Tübingen
Local organizational units
Internal Medicine Department III
Department of Internal Medicine
Hospitals and clinical institutes, Faculty of Medicine
Hospitals and clinical institutes, Faculty of Medicine
Funders
Leipzig, Sachsen, Germany