Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05963698
Status:
RECRUITING
Last Update Posted:
2023-12-18
First Post:
2023-07-05
Brief Title:
The Fourth Left Atrial Appendage Occlusion Study
Sponsor:
Hamilton Health Sciences Corporation
Organization:
Hamilton Health Sciences Corporation
Study Overview
Official Title:
The Fourth Left Atrial Appendage Occlusion Study LAAOS-4
Status:
RECRUITING
Status Verified Date:
2024-09
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:
LAAOS-4
Brief Summary:
LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation who remain at high risk of stroke despite receiving ongoing treatment with oral anticoagulation
Detailed Description:
LAAOS-4 is a multicentre prospective open-label randomized controlled trial with blinded assessment of endpoints PROBE to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation who remain at high risk of stroke despite receiving ongoing treatment with oral anticoagulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None