ACURATE neo2 PMCF: ACURATE neo2* (S2410): Post Market Clinical Follow-up Study
- Conditions
- 10046973severe native aortic valve stenosisaortic valve stenosis
- Registration Number
- NL-OMON52458
- Lead Sponsor
- Boston Scientific International SAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 65
There are no specific inclusion criteria set for this post-market surveillance
study. A subject must sign an IEC/REB-approved ICF and the ACURATE neo2
Transfemoral Aortic Valve System should be used according to the commercial
IFU.
EC1. Subject has a previous bioprosthesis in the aortic position.
EC2. Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V).
EC3. Subject has atrial fibrillation that cannot be rate controlled to
ventricular response rate < 60 bpm.
EC4. Subject is expected to undergo chronic anticoagulation therapy after the
TAVI procedure.
Note: Subjects treated with short-term anticoagulation post-procedure can be
included in the study; in these subjects the 30-day imaging will be performed
30 days after discontinuation of anticoagulation.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Safety Endpoint: All-cause mortality at 30 days after the index implant<br /><br>procedure.<br /><br>Primary Imaging Endpoint: Hypoattenuated leaflet thickening (HALT) as measured<br /><br>by 4D CT at 30 days</p><br>
- Secondary Outcome Measures
Name Time Method <p>Additional measurements based on the Valve Academic Research Consortiuma (VARC)<br /><br>endpoints and definitions will be collected<br /><br>peri- and post-procedure, at pre-discharge, at 30 days, and annually 1 through<br /><br>5 years after the implant procedure, unless otherwise<br /><br>specified: see protocol ACURATE neo2 PMCF Study-Specific Protocol 92383173<br /><br>Rev/Ver B - pages 7-9</p><br>