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The purpose of this study is to verify the effectiveness and safety of the Huawei Device software (ECG APP), which can be used to analyze, store and display the ECG data transmitted by the single-lead ECG acquisition device. The software can be used for the analysis of sinus rhythm, atrial fibrillation, and premature beats(ventricular premature beats and atrial premature beats) in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial Fibrillation | Experimental |
| |
| Premature beats | Experimental |
| |
| Sinus Rhythm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12-Lead ECG(I-lead) | Device | All participants will simultaneously record 12-lead ECGs(I-lead) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of atrial fibrillation identification | 30seconds | |
| Sensitivity and specificity of premature beat identification | 30seconds | |
| Sensitivity and specificity of sinus rhythm identification | 30seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate of ventricular premature beats and atrial premature beats | 30seconds | |
| Total coincidence rate of measurement and identification | 30seconds | |
| ECG waveform similarity |
| Measure | Description | Time Frame |
|---|---|---|
| Software failure rate | 30seconds | |
| The incidence of adverse events and serious adverse events | 30seconds |
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 have good compliance, and can cooperate to complete this research by himself/herself; 4)Patients who volunteer to participate and have signed an informed consent form.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guo Yutao, doctor | The First Medical Center of the Chinese PLA General Hospital & Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Medical Center of the Chinese PLA General Hospital & Medical School | Beijing | China | ||||
| The First Affiliated Hospital of Sun Yat-sen University |
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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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| 30seconds |
| R wave amplitude consistency | 30seconds |
| Heart rate accuracy | 30seconds |
| Software usability | 30seconds |
| Guangzhou |
| China |