Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-01-03 @ 9:03 AM
Study NCT ID:
NCT04704258
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2021-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NAUTILUS CE-mark Trial of the FLOWer Cerebral Embolic Protection Device
Sponsor:
AorticLab Srl
Organization:
Study Overview
Official Title:
Clinical Study of a Novel Transcatheter Anti-embolic Filter (FLOWer) for Cerebral Protection During Aortic Valve Interventions
Status:
COMPLETED
Status Verified Date:
2024-02
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:
NAUTILUS
Brief Summary:
The purpose of this clinical study is to assess the safety, performance, and treatment effect of the use of the AorticLab FLOWer System, in preventing cerebral thromboembolic complications in patients with indication for a TAVI (Transcatheter Aortic Valve Implant).
Detailed Description:
A single arm, prospective, multicenter non-randomized clinical study of the AorticLab FLOWer System to prevent embolic complications during transcatheter aortic valve procedures.
Study Oversight
Has Oversight DMC:
True
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?: