Status:
ENROLLING_BY_INVITATION
Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
Lead Sponsor:
National University of Ireland, Galway, Ireland
Collaborating Sponsors:
Galway University Hospitals
CORRIB Research Centre for Advanced Imaging and Core Lab, Galway, Ireland
Conditions:
Aortic Stenosis
Transcatheter Aortic Valve Implantation
Eligibility:
All Genders
18+ years
Brief 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, proced...
Detailed Description
As the use of TAVI in BAV anatomy expands, it is important to systematically evaluate clinical outcomes from various THV technologies among BAV patients. It is essential to consider short-, and longer...
Eligibility Criteria
Inclusion
- 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
- Failure to obtain the patient's consent
- Failure to obtain the follow-up clinical data or cardiac imaging required for the study primary endpoints.
Key Trial Info
Start Date :
September 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06212050
Start Date
September 15 2023
End Date
June 30 2024
Last Update
June 21 2024
Active Locations (3)
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1
Kerckhoff Heart and Lung Centre
Bad Nauheim, Germany
2
Galway University Hospital
Galway, Ireland
3
Karolinska University Hospital
Stockholm, Sweden