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

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Description

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).

Targeted Conditions

Study Overview

Start Date
October 4, 2022
Completion Date
September 1, 2025
Enrollment
2000
Date Posted
September 14, 2022
Gender
All

Locations

Full Address
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

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, Germany

Universitäres Herz- und Gefäßzentrum Hamburg
Hamburg, Germany

Universitätsklinikum Köln
Köln, 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

Universitätsspital Basel
Basel, Switzerland

Luzerner Kantonsspital
Luzern, Switzerland

Universitätsspital Zürich
Zürich, Switzerland

Eligibility

Study Population
Patients will be recruited from primary care clinics. As the ACURATE neo2™ is approved for use to treat patients with severe aortic stenosis, the inclusion criteria are broad in order to allow the device to be used in an all-comers population and following the instructions for use (IFU).
Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

Planned transcatheter treatment of severe aortic stenosis with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system.
Age ≥ 18 years of age
Written informed consent by patient and/or legal representative

Exclusion Criteria:

Patient is unlikely to be able or willing to follow the investigator's instructions during study participation.
Patients temporally unable to provide written informed consent (e. g. unconscious emergency patients)
3. Patients placed in an institution by official or court order

Study Contact Info

Study Contact Name
Holger Thiele, Prof. Dr.; Mohamed Abdel-Wahab, Prof. Dr.
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
There are four leading causes of valvular aortic valve stenosis, namely: calcific aortic stenosis, congenital aortic valve malformations, rheumatic aortic valve stenosis, and endocarditis. Calcific aortic valve stenosis is a chronic progressive disease, and the predominant cause of aortic valve stenosis in the Western world. Multiple mechanisms influencing the progression of aortic valve stenosis have been identified. However, there is still no sufficient drug therapy to stop or reverse the process.

If high-grade aortic valve stenosis becomes symptomatic, death rates increase up to 50% in 2 years.Many patients with severe and symptomatic aortic stenosis are successfully treated with surgical aortic valve replacement (SAVR), which can reduce symptoms and improve survival. However, up to one-third of symptomatic patients are considered inoperable due to comorbidities and the high risk of surgery. This treatment gap forced the development of less invasive approaches for patients with aortic stenosis considered inoperable and led to the development of TAVI. Later, TAVI has also been considered in the European Society of Cardiology/European Association for Cardio-Thoracic Surgery (ESC/EACTS) 2017 and American Heart Association/American College of Cardiology (AHA/ACC) guidelines for the management of patients with valvular heart disease and intermediate surgical risk and recently, new landmark studies have expanded the use of TAVI into the low surgical risk field.

For the establishment of TAVI as the first line treatment option in lower risk patients, further improvement with regard to adverse outcomes associated with TAVI (e.g. vascular complications, rates of paravalvular leak/aortic regurgitation and the need for permanent pacemakers) will be essential. Therefore, large registries are needed to detect rare events and tendencies in a real-world setting.

The PROVE study will collect baseline, procedural and follow-up data. In addition, it will serve as an imaging library (angiography, echocardiography and cardiac computed tomography) to evaluate the potential advantages and disadvantages of the ACURATE neo2.
NCTid (if applicable)
NCT05539573