Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552468
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-04
Brief Title:
Efficacy and Accuracy of EStimation for BurdEn of Atrial Fibrillation by PPG Using a Smart Watch
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Accuracy of Estimation for Burden of Atrial Fibrillation by PPG Using a Smart Watch EASE-AF Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EASE-AF
Brief Summary:
The study aims to assess the efficacy and accuracy of using an Electrocardiograph ECG watch with photoplethysmography PPG for monitoring atrial fibrillation AF burden The PPG data will be automatically analyzed using software and the results will be compared with cardiologist-annotated ECG collected by a single-lead ECG patch
Detailed Description:
This study is a self-controlled clinical trial conducted at the Department of Cardiology Beijing Anzhen Hospital affiliated with Capital Medical University Eligible patients admitted to the hospital for AF will be enrolled After obtaining written informed consent from the participants participants will be instructed to wear both a single-lead ECG patch and a smartwatch with PPG ECG and PPG data will be collected continuously during hospitalization The collected PPG data will be analyzed automatically using the analysis software provided by Xinjikang Co Ltd The results will then be compared with the cardiologist-annotated ECG results to investigate the differences between the PPG data and ECG data in identifying AF and estimation of AF burden
Study Oversight
Has Oversight DMC:
None
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?:
None