Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535659
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-21
Brief Title:
VitaFlow LIBERTY Europe
Sponsor:
None
Organization:
None
Study Overview
Official Title:
VitaFlow Liberty Transcatheter Aortic Valve System Post-market Clinical Follow-up Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective single-arm multi-center observational post-market registry to document the clinical safety and performance of MicroPort CardioFlow VitaFlow Liberty Transcatheter Aortic Valve System in the routine practice for the treatment of severe aortic valve stenosis The primary endpoint is the composite rate of all-cause mortality and stroke with disability at 12 months
Patients will receive transcatheter aortic valve replacement and examinations at the screening procedure discharge and follow-up per local standard of care
Patients will receive transcatheter aortic valve replacement and examinations at the screening procedure discharge and follow-up per local standard of care
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None