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ENROLLING BY INVITATION
NCT06212050

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

Sponsor: National University of Ireland, Galway, Ireland

View on ClinicalTrials.gov

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

Interventions

DEVICE

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