Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
Study NCT ID:
NCT05135403
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2021-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)
Sponsor:
Kestra Medical Technologies, Inc.
Organization:
Study Overview
Official Title:
ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)
Status:
RECRUITING
Status Verified Date:
2025-08
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:
ACE-PAS
Brief Summary:
Active surveillance study using real-world data collected in the ASSURE Patient Registry. Outcome measures are based on analysis of ASSURE Registry data including data recorded by the WCD then annotated by clinical experts in electrophysiology.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: