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Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
Sponsor: National University of Ireland, Galway, Ireland
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.
Official title: Investigator Initiated Multicenter Study to Evaluate the Feasibility, Safety and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis - The Neo2 BAV Registry
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2023-09-15
Completion Date
2024-06-30
Last Updated
2024-06-21
Healthy Volunteers
No
Conditions
Interventions
Transcatheter Aortic Valve Implantation
TAVI in patients with severe BAV stenosis using ACURATE neo2
Locations (3)
Kerckhoff Heart and Lung Centre
Bad Nauheim, Germany
Galway University Hospital
Galway, Ireland
Karolinska University Hospital
Stockholm, Sweden