Atrial FibrillationEASE-AFNCT06552468
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
An observational study of Atrial Fibrillation, run by Beijing Anzhen Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- AF monitoring by a smartwatch with PPG
- Type of treatment
- Medical device
- How many people
- 1,054 participants
- Where
- 1 siteChina
- Study dates
- 14 Jan 2024to 27 Nov 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with AF who were hospitalized for AF in the Department of Cardiology, Beijing Anzhen Hospital.
Who may be able to join
- Patients must meet all of the following criteria to be included in the study:
- Aged 18 and above;
- There was a clear electrocardiogram record of atrial fibrillation in the past, and atrial fibrillation ablation surgery will be performed during this hospitalization；
- Patients who agree to wear both the "ECG watch" and the "ECG recorder" simultaneously；
Who cannot join
- Patients who meet any of the following criteria cannot be included in this study:
- Unable to complete the wearing due to problems such as limited mobility.
- Severe skin diseases such as severe skin allergies or skin ulcers.
- Those with chronic insomnia who have not received drug treatment.
- Patients with severe cardiovascular and cerebrovascular diseases who may need emergency treatment at any time.
- Those with a history of Parkinson's disease, schizophrenia, or epilepsy.
- Black people and those with overly dark skin.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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：
- 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.
- 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.
- 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
- Being tested
- AF monitoring by a smartwatch with PPG
- Keywords
- Atrial Fibrillation Burden、 AI Correction、W-PPG
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF monitoring by a smartwatch with PPGDevice
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
Automatically analyze the W-PPG data and the W-PPG data calibrated by W-ECG.
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.
Measured: One day
Secondary outcomes (1)
Automatically analyze the W-PPG data and the W-PPG data calibrated by W-ECG.
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.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start14 Jan 2024
- Primary completion27 Jun 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,054 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552468
- Sponsor's protocol ID
- KS2024008
- Acronym
- EASE-AF
- Status last verified
- Mar 2024
- First submitted
- 4 Aug 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zuo S, Wang J, Wang X, Feng H, Zhao Y, Li F, Wei S, Zhou L, Zhao Z, Chen S, Kong X, Wang J, He L, Xia S, Li X, Zhang J, Liu X, Guo X, Zhou N, Li S, Jiang C, Tang R, Sang C, Long D, Du X, Dong J, Zhu W, Ma C. A Dual-Modal Wearable PPG Smartwatch with AI-Enhanced Correction for High-Accuracy and Continuous AF Burden Assessment. Adv Sci (Weinh). 2026 Jul 14:e76627. doi: 10.1002/advs.76627. Online ahead of print.
PubMed 42446176
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06552468
- Acronym / sponsor ID
- EASE-AF / KS2024008
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation Burden、 AI Correction、W-PPG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,054 participants (actual)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 14 Jan 2024 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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：
- 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.
- 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.
- Voluntary Measurement: Active measurement of W-ECG During the period when the subject is wearing the watch, they can voluntarily measure W-ECG.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with AF who were hospitalized for AF in the Department of Cardiology, Beijing Anzhen Hospital.
Key inclusion criteria (4 listed)
- Aged 18 and above;
- There was a clear electrocardiogram record of atrial fibrillation in the past, and atrial fibrillation ablation surgery will be performed during this hospitalization；
- Patients who agree to wear both the "ECG watch" and the "ECG recorder" simultaneously；
Key exclusion criteria (7 listed)
- Unable to complete the wearing due to problems such as limited mobility.
- Severe skin diseases such as severe skin allergies or skin ulcers.
- Those with chronic insomnia who have not received drug treatment.
- Patients with severe cardiovascular and cerebrovascular diseases who may need emergency treatment at any time.
- Those with a history of Parkinson's disease, schizophrenia, or epilepsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AF monitoring by a smartwatch with PPGThe 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). | Device | – |
Primary outcome
Automatically analyze the W-PPG data and the W-PPG data calibrated by W-ECG.
Time frame: 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.
1 secondary outcome
Automatically analyze the W-PPG data and the W-PPG data calibrated by W-ECG.
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Derived from this study: PubMed 42446176Zuo S, Wang J, Wang X, Feng H, Zhao Y, Li F, Wei S, Zhou L, Zhao Z, Chen S, Kong X, Wang J, He L, Xia S, Li X, Zhang J, Liu X, Guo X, Zhou N, Li S, Jiang C, Tang R, Sang C, Long D, Du X, Dong J, Zhu W, Ma C. A Dual-Modal Wearable PPG Smartwatch with AI-Enhanced Correction for High-Accuracy and Continuous AF Burden Assessment. Adv Sci (Weinh). 2026 Jul 14:e76627. doi: 10.1002/advs.76627. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Automatically analyze the W-PPG data and the W-PPG data calibrated by W-ECG. (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06552468, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.