PROVE ACURATE neo2™ - Post Market Safety and Performance Surveillance in Aortic Stenosis

Active, not recruitingOBSERVATIONAL
Enrollment

1,043

Participants

Timeline

Start Date

October 4, 2022

Primary Completion Date

April 30, 2025

Study Completion Date

April 30, 2025

Conditions
Aortic Stenosis
Interventions
DEVICE

Planned TAVI with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system.

"The study will collect data from patients treated with the ACURATE neo2™ and its transfemoral delivery system following standard TAVI practice at each participating center. All patients will be followed to 12 months after the implant procedure. The study is divided into three periods:~1. Screening period: from screening to enrollment if study criteria are met.~2. Implantation procedure: immediately pre-implant to 24 hours post-procedure.~3. Follow-up period: at hospital discharge, at 30 days and at 12 months post-procedure."

Trial Locations (27)

Unknown

Jacques Cartier Private Hospital Massy, Massy

Centre Cardiologique du Nord Saint-Denis, Saint-Denis

Universitätsklinikum Augsburg, Augsburg

Zentralklinik Bad Berka GmbH, Bad Berka

Kerckhoff-Klinik GmbH, Bad Nauheim

Rhön Klinikum, Campus Bad Neustadt, Bad Neustadt an der Saale

Herz- und Diabeteszentrum NRW, Bad Oeynhausen

Schüchtermann-Schiller'sche Kliniken Bad Rothenfelde GmbH & Co. KG, Bad Rothenfelde

Deutsches Herzzentrum der Charité, Berlin

Universitätsklinikum Köln, Cologne

St. Johannes Hospital, Dortmund

Herzzentrum Dresden GmbH Universitätsklinik an der TU Dresden, Dresden

Universitätsklinikum Düsseldorf, Düsseldorf

Elisabeth-Krankenhaus, Essen

Universitätsklinikum Frankfurt, Frankfurt

Universitätsklinikum Freiburg - Bad Krozingen, Freiburg im Breisgau

Universitäres Herz- und Gefäßzentrum Hamburg, Hamburg

Heart Center Leipzig at Leipzig University, Leipzig

Augustinum, München

Deutsches Herzzentrum, München

LMU Klinikum der Universität München, München

Uniklinikum Regensburg, Regensburg

Universitätsklinikum Tübingen, Tübingen

Lund University, Lund

Universitätsspital Basel, Basel

Luzerner Kantonsspital, Lucerne

Universitätsspital Zürich, Zurich

All Listed Sponsors
collaborator

National University of Ireland, Galway

UNKNOWN

lead

University of Leipzig

OTHER