Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04674111
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2020-12-14
Brief Title:
Vortex - Temporary Percutaneous Transvalvular Circulatory Support System Feasibility Study
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
Vortex - First in Human Study to Evaluate the Feasibility Safety Clinical and Technical Success of the Vortex Temporary Percutaneous Transvalvular Circulatory Support System Vortex System
Status:
COMPLETED
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:
Vortex-FIH
Brief Summary:
Vortex - First in Human study to evaluate the feasibility safety clinical and technical success of the Vortex temporary percutaneous transvalvular circulatory support system Vortex System
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None