Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375590
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-07
Brief Title:
NavIIcusp Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience
Sponsor:
Didier TCHETCHE
Organization:
Clinique Pasteur
Study Overview
Official Title:
NavIIcusp Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None