NCT06552468

A Study on the Effectiveness of the Application of an Artificial Intelligence Algorithm for Calibrating PPG With ECG to Improve the Accuracy of Atrial Fibrillation Burden Estimation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,054 (actual)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Use the ECG watch to collect W-PPG and W-ECG data. Through artificial intelligence algorithms, compare the W-PPG data collected by the ECG watch and the W-PPG data calibrated by the W-ECG data of the ECG watch with the P-ECG data manually annotated after being collected by the ECG recorder. Then evaluate the effectiveness of the calibrated algorithm in improving the accuracy of estimating atrial fibrillation burden.

Detailed description

After the subjects are fully informed and sign the informed consent form, they will be asked to wear the "ECG recorder" and the "ECG watch" simultaneously to collect P-ECG data as well as W-PPG and W-ECG data respectively. The collection period is from the patient's admission to the time before the patient's surgery. The collected data will be analyzed by the "Smart-AF" of Xinjikang Company. The W-PPG data collected by the ECG watch and the W-PPG data calibrated by the W-ECG data of the ECG watch will be compared with the P-ECG data that has been manually annotated after being collected by the ECG recorder. The differences in identifying atrial fibrillation and in the statistics of atrial fibrillation burden between the W-PPG data of atrial fibrillation patients and the P-ECG data as well as the W-PPG and P-ECG data calibrated by comparison with the W-ECG data will be compared. ECG Watch ECG Monitoring Method： 1. Positive Alert: W-PPG detects atrial fibrillation and prompts measurement of W-ECG When W-PPG detects atrial fibrillation, the data is uploaded to the server for confirmation. If the server detects atrial fibrillation, it triggers a vibration message to prompt the measurement of W-ECG. If a valid W-ECG measurement is not completed within 5 minutes after the message alert, a vibration reminder is triggered again, with a maximum of two reminders per trigger point. When the daily reminder count reaches 10, no further reminders will be given; for the first 5 reminders, each pair of reminders must be at least 20 minutes apart, and for the last 5 reminders, each pair must be at least 40 minutes apart. 2. Periodic Reminder: Scheduled reminders for W-ECG measurement Vibration reminders are triggered at fixed times: 09:00, 10:30, 11:30, 13:00, 14:00, 15:30, 17:00, 18:00, 19:00, 20:30. If a 60-second W-ECG measurement is not completed within 5 minutes after each trigger, a vibration reminder is triggered again, with a maximum of two vibration reminders per trigger point. 3. Voluntary Measurement: Active measurement of W-ECG During the period when the subject is wearing the watch, they can voluntarily measure W-ECG.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	AF monitoring by a smartwatch with PPG	The device we used for intervention is a smartwatch (JKwear 1, Chengdu CVhealth Science and Technology Co., Ltd, CN) for collecting watch-recorded-PPG (W-PPG).

Timeline

• Start date: 2024-01-14
• Primary completion: 2024-06-27
• Completion: 2024-11-27
• First posted: 2024-08-14
• Last updated: 2024-12-31

Locations

1 site across 1 country: China