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This study aims to validate the efficacy and safety of the Pulse Wave-based Atrial Fibrillation and Premature Beat Alert Software (Huawei Device Co., Ltd.). This software can provide alerts, store and display PPG data transmitted from smartwatches or fitness trackers. The software is limited to alerting of atrial fibrillation and premature beat, and the results are only for clinical reference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial Fibrillation | Experimental |
| |
| Premature beats | Experimental |
| |
| No evidence of atrial fibrillation/premature beats | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECG | Device | Each participant undergoes testing with both the investigation device and the control device simultaneously. The results of the investigation device, which are obtained through pulse wave data analysis at the wrist, are compared to the investigator's interpretation of the ECG. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of atrial fibrillation identification in a single measurement | 45seconds | |
| Sensitivity and specificity of premature beat identification in a single measurement | 45seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy in identifying the non-arrhythmia in a single measurement | 45seconds | |
| Total identification compliance rate in a single measurement | 45seconds | |
| Software usability |
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Inclusion Criteria:
Patients over 18 years old, regardless of gender;
Participants who meet one of the following conditions according to the medical history in the past 3 months or the ECG during the screening period:
Patients who volunteer to participate and have signed an informed consent form.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhujiang Hospital of Southern Medical University | Guangzhou | China |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| 45seconds |
| D004568 | Electrodiagnosis |