Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-31 @ 9:20 AM
Study NCT ID:
NCT05089435
Status:
UNKNOWN
Last Update Posted:
2022-05-10
First Post:
2021-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-label Study of EZYPRO® in Atrial Fibrillation Detection on ESUS Patients
Sponsor:
Sigknow Biomedical Co., Ltd.
Organization:
Study Overview
Official Title:
An Open-label Study to Evaluate the Effectiveness and Safety of EZYPRO® in Atrial Fibrillation Detection in Nearly Embolic Stroke of Undetermined Source (ESUS) Patient
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
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 aim of the study is to evaluate the effectiveness and safety of the 14-day continuous ECG patch monitor (EZYPRO®) compared with a 24-hour Holter monitor in the detection of atrial fibrillation (AF) among ESUS patients.
Detailed Description:
None
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?: