ProjektPROVE ACURATE neo2TM - post market safety and performance surveillance in aorticstenosis
Grunddaten
Titel:
PROVE ACURATE neo2TM - post market safety and performance surveillance in aorticstenosis
Laufzeit:
01.06.2023 bis 31.12.2026
Abstract / Kurz- beschreibung:
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)
Beteiligte Mitarbeiter/innen
Leiter/innen
Medizinische Universitätsklinik und Poliklinik (Department)
Kliniken und klinische Institute, Medizinische Fakultät
Kliniken und klinische Institute, Medizinische Fakultät
Ansprechpartner/innen
Medizinische Fakultät
Universität Tübingen
Universität Tübingen
Weitere Mitarbeiter/innen
Medizinische Fakultät
Universität Tübingen
Universität Tübingen
Lokale Einrichtungen
Abteilung Innere Medizin III
Medizinische Universitätsklinik und Poliklinik (Department)
Kliniken und klinische Institute, Medizinische Fakultät
Kliniken und klinische Institute, Medizinische Fakultät
Geldgeber
Leipzig, Sachsen, Deutschland