NCT04655248

ACURATE neo2™ Post Market Clinical Follow up Study

About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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

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.

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details

Contition

Aortic Valve Stenosis,Aortic Valve Calcification,Aortic Diseases

Age (in years)

18+

Participants needed

250

Est. Completion Date

Dec 31, 2026

Treatment type

Observational

Sponsor

Boston Scientific Corporation

ClinicalTrials.gov identifier

NCT04655248

Study number

S2410

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