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

NCT06212050 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-06-21

No results posted yet for this study

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.

Conditions

  • Aortic Stenosis
  • Transcatheter Aortic Valve Implantation
  • Bicuspid Aortic Valve
  • Transcatheter Aortic Valve Replacement

Interventions

DEVICE

Transcatheter Aortic Valve Implantation

TAVI in patients with severe BAV stenosis using ACURATE neo2

Sponsors & Collaborators

  • Galway University Hospitals

    collaborator UNKNOWN

  • CORRIB Research Centre for Advanced Imaging and Core Lab, Galway, Ireland

    collaborator UNKNOWN

  • Karolinska University Hospital

    collaborator OTHER

  • Kerckhoff Heart Center

    collaborator OTHER

  • National University of Ireland, Galway, Ireland

    lead OTHER

Principal Investigators

  • Darren Mylotte, MD, PhD · University of Galway, Galway University Hospital

  • Andreas Ruck, MD · Karolinska University Hospital

  • Won-Keun Kim, MD · Kerckhoff Heart and Lung Centre

  • Osama Soliman, MD, PhD · University of Galway, Galway University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-15
Primary Completion
2024-03-01
Completion
2024-06-30

Countries

  • Germany
  • Ireland
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06212050 on ClinicalTrials.gov