By InvitationNot Applicable

Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis

Germany, Ireland, Sweden200 participantsStarted 2023-09-15

Plain-language summary

The goal of the NEO2 BAV registry is to investigate the safety, effectiveness, and clinical performance of TAVI using the ACURATE neo2 valve in patients with severe BAV stenosis. The clinical, procedural, and imaging characteristics will be collected from patients with severe BAV stenosis, regardless of the phenotype, and treated with TAVI using the ACURATE neo2 bioprosthesis worldwide.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged ≥ 18 years * Patients with severe AS and any BAV phenotype and indicated for TAVI based on the local heart team decision. * Patient treated with ACURATE neo2 THV. Exclusion Criteria: * Failure to obtain the patient's consent * Failure to obtain the follow-up clinical data or cardiac imaging required for the study primary endpoints.

What they're measuring

VARC-3 device success

Timeframe: 30-Day

VARC-3 early safety

Timeframe: 30-Day

Trial details

NCT IDNCT06212050

SponsorNational University of Ireland, Galway, Ireland

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-03-01

View on ClinicalTrials.gov More Aortic Stenosis trials