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A Randomized, Crossover Trial is conducted to Evaluate Consistency Atrial fibrillation diagnosis between the Wearable Dynamic ECG Recorder and the Control device.
In this investigation, the following indicators is also evaluated:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| use two kinds of device successively | Experimental | the same participant use a Wearable Dynamic ECG Recorder and 12-lead ECG to record heart rate and atrial fibrillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable Dynamic ECG Recorder | Device | use a Wearable Dynamic ECG Recorder to record heart rate and atrial fibrillation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Consistent rate of atrial fibrillation diagnosis | Electrical signals from ECG electrodes are collected with tested device and gold standard device. An automatic diagnosis of atrial fibrillation made with the tested device, and diagnosis of atrial fibrillation is made by the investigators with gold standard device. Diagnosis results include: "with atrial fibrillation (AF)", "without atrial fibrillation (No AF)", or "indecipherable". After the diagnosis, the number of "with atrial fibrillation (AF)", "without atrial fibrillation (No AF)", or "indecipherable" cases measured by the two devices are calculated according to table 1, and then the results are evaluated for 3×3 matching consistency. | second 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation | Sensitivity and specificity of the ECG App algorithm in detecting atrial fibrillation compared with physician-adjudicated Gold Standard ECG recorder. Per the protocol, only readable and classifiable (classifiable analysis set) paired recordings are included in the diagnostic performance assessment. | second 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measures 1 | 1.Scoring system for skin reaction:No erythema, score 0; Very slight erythema (barely perceptible), score 1; Well-defined erythema, score2;Moderate erythema, score 3;Severe erythema (beet-redness) to eschar formation preventing grading of erythema, score 4. | second 60 |
| Safety measures 2 |
Inclusion Criteria:
Phase 1:
Phase 2:
Exclusion Criteria:
• < 18 years old
Phase 1:
Phase 2:
- Critical patients
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruogu li, MD | Contact | 86-013916139778 | Pengyimin1977@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest hospital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 12-lead ECG recordings | Device | use a 12-lead ECG recordings to record heart rate and atrial fibrillation |
|
| waveform qualitative assessment 1 | 1)The proportion of paired ECG strips appear to overlay to the unaided eye > 0.80. | second 60 |
| waveform qualitative assessment 2 | 2)The proportion of paired R-wave amplitude measurements within 2 mm of each other > 0.80 | second 60 |
2. Adverse event (AE) |
| second 60 |
| Safety measures 3 | 3. Equipment defector failure for example: unable to wear, no results output, signal interruption. | second 60 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |