Active — Not RecruitingNot Applicable

ACURATE neo2™ Post Market Clinical Follow up Study

Denmark, Germany250 participantsStarted 2020-12-16

Plain-language summary

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 participate

Age range18 Years

SexALL

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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.

What they're measuring

Primary Safety Endpoint:

Timeframe: 30 days

Primary Imaging Endpoint:

Timeframe: 30 days

Trial details

NCT IDNCT04655248

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-03-09

View on ClinicalTrials.gov More Aortic Valve Stenosis trials