NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience

NCT06375590 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-04-19

No results posted yet for this study

Summary

The aim of this prospective registry is to evaluate the clinical impact of the new Navitor prosthesis (Abbott, Minneapolis, MN, USA) in BAV and evaluate both the main sizing methods (the classical annular or the supra-annular with ICD measurement at 4 mm above the virtual basal ring).

Conditions

  • Bicuspid Aortic Valve

Interventions

DEVICE

Transcatheter Aortic Valve Implantation

Transcatheter treatment of bicuspid stenosis with the Navitor platform

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY
  • Didier TCHETCHE

    lead OTHER

Principal Investigators

  • Didier Tchétché, MD · Clinique Pasteur

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2025-05-01
Completion
2026-05-01
FDA Device
Yes

Countries

  • France

Study Locations

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Entities

Companies

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 NCT06375590 on ClinicalTrials.gov