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

NCT ID: NCT05539573

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1043 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-04
• Study Completion Date: 2025-04-30

Brief 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).

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.

Conditions

Aortic Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Treatment

Patients with planned transcatheter treatment of severe aortic stenosis with the ACURATE neo2™ aortic bioprosthesis and ACURATE neo2™ transfemoral delivery system.

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

Intervention Type: DEVICE

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.

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University of Ireland, Galway

UNKNOWN

Sponsor Role: collaborator

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

Holger Thiele

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Holger Thiele, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Leipzig University

Locations

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

Countries

France; Germany; Sweden; Switzerland

Other Identifiers

PROVE

Identifier Type: -

Identifier Source: org_study_id