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PROVE ACURATE neo2™ - Post Market Safety and Performance Surveillance in Aortic Stenosis
Sponsor: University of Leipzig
Summary
Aortic valve sclerosis (aortic valve thickening and calcification without pressure gradient) is one of the most common valvular abnormalities in the Western world. Per year, about 1.8-1.9% of these patients develop aortic valve stenosis which will eventually be treated by TAVI (Transcatheter aortic valve implantation). The purpose of this study is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo2™ aortic bioprosthesis and the ACURATE neo2™ transfemoral delivery system, hereafter referred to as the ACURATE neo2™ and transfemoral delivery system in the context of an observational investigator initiated trial (IIT).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1043
Start Date
2022-10-04
Completion Date
2025-04
Last Updated
2024-04-10
Healthy Volunteers
Not specified
Conditions
Interventions
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.
Locations (27)
Jacques Cartier Private Hospital Massy
Massy, France
Centre Cardiologique du Nord Saint-Denis
Saint-Denis, France
Universitätsklinikum Augsburg
Augsburg, Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Germany
Kerckhoff-Klinik GmbH
Bad Nauheim, Germany
Rhön Klinikum, Campus Bad Neustadt
Bad Neustadt an der Saale, Germany
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany
Schüchtermann-Schiller'sche Kliniken Bad Rothenfelde GmbH & Co. KG
Bad Rothenfelde, Germany
Deutsches Herzzentrum der Charité
Berlin, Germany
Universitätsklinikum Köln
Cologne, Germany
St. Johannes Hospital
Dortmund, Germany
Herzzentrum Dresden GmbH Universitätsklinik an der TU Dresden
Dresden, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Elisabeth-Krankenhaus
Essen, Germany
Universitätsklinikum Frankfurt
Frankfurt, Germany
Universitätsklinikum Freiburg - Bad Krozingen
Freiburg im Breisgau, Germany
Universitäres Herz- und Gefäßzentrum Hamburg
Hamburg, Germany
Heart Center Leipzig at Leipzig University
Leipzig, Germany
Augustinum
München, Germany
Deutsches Herzzentrum
München, Germany
LMU Klinikum der Universität München
München, Germany
Uniklinikum Regensburg
Regensburg, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Lund University
Lund, Sweden
Universitätsspital Basel
Basel, Switzerland
Luzerner Kantonsspital
Lucerne, Switzerland
Universitätsspital Zürich
Zurich, Switzerland