Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-30 @ 10:30 AM
Study NCT ID:
NCT04196335
Status:
COMPLETED
Last Update Posted:
2025-06-18
First Post:
2019-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
I Can sEe Left Atrial Appendage (ICELAA) Clinical Study
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
I Can sEe Left Atrial Appendage (ICELAA) Clinical Study
Status:
COMPLETED
Status Verified Date:
2022-06
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:
ICELAA
Brief Summary:
The primary objective of this study is to assess the efficacy and safety of using intra-procedural intracardiac echocardiography (ICE) for WATCHMAN FLX Device implants in subjects with non-valvular atrial fibrillation to reduce the risk of stroke.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: