ACURATE neo2™ Post Market Clinical Follow up Study

Boston Scientific

Status: Active, not recruiting

Conditions: Aortic Valve Stenosis; Aortic Diseases; Aortic Valve Calcification

Treatments: Device: Transcatheter Aortic Valve Implantation/Replacement

Study type: Observational

Funder types: Industry

Identifiers

NCT04655248

S2410

Details and patient eligibility

About

The ACURATE Neo2 PMCF is aimed at collecting clinical and device performance outcomes data with the ACURATE neo2™ Transfemoral Aortic Valve System as used in routine clinical practice for the treatment of severe calcific aortic stenosis.

Full description

ACURATE neo2 PMCF is a prospective, open-label, single-arm, multicenter, observational post-market surveillance study. All subjects deemed treatable with the ACURATE neo2 valve will be approached to participate in the study.

A subject who provides an Informed Consent Form (ICF) approved by the Independent Ethics Committee (IEC) and signed by the subject or the subject's legally authorized representative is considered enrolled once an attempt is made to insert the commercially available ACURATE neo2 Transfemoral Delivery System. Approximately 200 subjects will be enrolled.

Follow-up will occur at pre-discharge, 30 days, 1 year, and then annually from 2 through 5 years post index procedure per standard of care. Visits are in-person through 1 year and in-person (preferred) or via telephone interview in years 2 through 5. All subjects will undergo 4D computed tomography (CT) imaging at 30 days and 1 year.

ACURATE neo2 PMCF Study Design Overview Abbreviations: CT=computed tomography; ICF=Informed Consent Form

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

There are no specific inclusion criteria set for this post-market surveillance study. A subject must sign an IEC-approved ICF and the ACURATE neo2 Transfemoral Aortic Valve System should be used according to the commercial IFU.

Exclusion criteria

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 these subjects the 30-day imaging will be performed 30 days after discontinuation of anticoagulation.