PROVE ACURATE neo2TM - post market safety and performance surveillance in aortic stenosis

• Conditions: Severe aortic stenosis; severe narrowing of the aortic valve; 10046973

• Registration Number: NL-OMON56524
• Lead Sponsor: eipzig University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1. Planned transcatheter treatment of severe aortic stenosis with the ACURATE
neo2 aortic bioprosthesis and ACURATE neo2 transfemoral delivery system. 2. Age
>= 18 years of age. 3. Written informed consent by patient and/or legal
representative.

Exclusion Criteria

1. Patient is unlikely to be able or willing to follow the investigator's
instructions during study
participation.
2. 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 & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>All-cause mortality up to 12 months follow-up.</p><br>