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

NCT05539573 | Active Not Recruiting

• 1 other identifier: PROVE
• Study Type: observational
• Target: 1,043
• Locations: 4 countries
• Sites: 27

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).

Conditions

Aortic Stenosis

Keywords

Transcatheter aortic valve implantation (TAVI); ACURATE neo2™ bioprosthetic aortic valve; ACURATE neo2™ transfemoral delivery system

Outcome Measures

Primary Outcomes (1)

• Time to all-cause death

  The individual survival time is calculated from the day of procedure up to death of any cause or up to the last last date on which the patient was known to be alive.

  through study completion, an average of 1 year

Secondary Outcomes (26)

• Mortality (count)

  through study completion, an average of 1 year

• Mortality (rate)

  through study completion, an average of 1 year

• Neurological events (count)

  through study completion, an average of 1 year

• Neurological events (rate)

  through study completion, an average of 1 year

• Myocardial infarction (count)

  through study completion, an average of 1 year

Other Outcomes (4)

• Composite endpoint: technical success

  at exit from procedure room

• Composite endpoint: device success

  at 30 days post procedure

• Early safety

  at 30 days post procedure

Study Arms (1)

Treatment

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

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

Interventions

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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)
• \. Patients placed in an institution by official or court order

Sponsors & Collaborators

• University of Leipzig: lead
• National University of Ireland, Galway: collaborator

Study Sites (27)

Jacques Cartier Private Hospital Massy

Massy, France

Location

Centre Cardiologique du Nord Saint-Denis

Saint-Denis, France

Location

Universitätsklinikum Augsburg

Augsburg, Germany

Location

Zentralklinik Bad Berka GmbH

Bad Berka, Germany

Location

Kerckhoff-Klinik GmbH

Bad Nauheim, Germany

Location

Rhön Klinikum, Campus Bad Neustadt

Bad Neustadt an der Saale, Germany

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

Location

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

Bad Rothenfelde, Germany

Location

Deutsches Herzzentrum der Charité

Berlin, Germany

Location

Universitätsklinikum Köln

Cologne, Germany

Location

St. Johannes Hospital

Dortmund, Germany

Location

Herzzentrum Dresden GmbH Universitätsklinik an der TU Dresden

Dresden, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Elisabeth-Krankenhaus

Essen, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, Germany

Location

Universitätsklinikum Freiburg - Bad Krozingen

Freiburg im Breisgau, Germany

Location

Universitäres Herz- und Gefäßzentrum Hamburg

Hamburg, Germany

Location

Heart Center Leipzig at Leipzig University

Leipzig, Germany

Location

Augustinum

München, Germany

Location

Deutsches Herzzentrum

München, Germany

Location

LMU Klinikum der Universität München

München, Germany

Location

Uniklinikum Regensburg

Regensburg, Germany

Location

Universitätsklinikum Tübingen

Tübingen, Germany

Location

Lund University

Lund, Sweden

Location

Universitätsspital Basel

Basel, Switzerland

Location

Luzerner Kantonsspital

Lucerne, Switzerland

Location

Universitätsspital Zürich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Holger Thiele, Prof. Dr.

  Leipzig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 14, 2022
• Study Start: October 4, 2022
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3); DE (21); FR (2); SE (1)