Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-03-05 @ 9:11 PM
Study NCT ID:
NCT02255851
Status:
COMPLETED
Last Update Posted:
2018-05-23
First Post:
2014-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sentinel(TM) Post-Market Registry
Sponsor:
Claret Medical
Organization:
Study Overview
Official Title:
Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement
Status:
COMPLETED
Status Verified Date:
2018-05
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 SENTINEL Post-Market Registry is a prospective, multi-center, registry using the CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve stenosis indicated for TAVR.
Subjects enrolled in the registry will undergo TAVR + Sentinel. Basic demographic information and detailed procedural data will be captured and documented in a registry case report form.
All Sentinel filters will be sent for histopathology at an independent core-lab.
Subjects enrolled in the registry will undergo TAVR + Sentinel. Basic demographic information and detailed procedural data will be captured and documented in a registry case report form.
All Sentinel filters will be sent for histopathology at an independent core-lab.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: