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
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT06552468
- Lead Sponsor
- Beijing Anzhen Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1054
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Automatically analyze the W-PPG data and the W-PPG data calibrated by W-ECG. One day Automatically analyze the W-PPG data and the W-PPG data calibrated by W-ECG through the "Smart-AF" of Xinjikang Company, and then compare the analyzed results with the P-ECG results manually annotated and proofread.
- Secondary Outcome Measures
Name Time Method Automatically analyze the W-PPG data and the W-PPG data calibrated by W-ECG. One day Automatically analyze the W-PPG data calibrated by W-ECG through artificial intelligence algorithms. Then compare the analyzed results with the P-ECG results that have been manually annotated and proofread. Finally, evaluate the sensitivity and specificity of the artificial intelligence algorithms in analyzing and identifying atrial fibrillation from the W-PPG data calibrated by W-ECG.
Trial Locations
- Locations (1)
Beijing Anzhen Hospital
🇨🇳Beijing, China