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| Name | Class |
|---|---|
| Clinact | OTHER |
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The proposed clinical study aims at validating the diagnostic performance, in comparison with a reference ECG, of Withings HWA08 watch for the automatic identification of atrial fibrillation (AF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial fibrillation (AF) | Experimental | Patients diagnosed with AF during reference ECG |
|
| Sinus Rhythm (SR) | Experimental | Patients diagnosed with SR during reference ECG |
|
| Other Arrythmia | Experimental | Patients diagnosed with an arrhythmia other than AF during the reference ECG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AF detection by ECG | Diagnostic Test | Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG |
|
| Measure | Description | Time Frame |
|---|---|---|
| AF and SR classification accuracy | sensitivity and specificity of detection of AF and SR from 1-lead ECG against reference 12-lead ECG | 1 visit (30 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of the 1-lead ECG strips | sensitivity and specificity of detection of AF and SR from 1-lead ECG strips reviewed by a blind, trained cardiologist against reference 12-lead ECG | 1 visit (30 minutes) |
| safety evaluation |
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Inclusion Criteria:
Exclusion Criteria:
vulnerable subject according to current regulation:
subject who refused to participate in the study
subject in linguistic or psychic incapacity to sign a written informed consent form
subject in physical incapacity to wear a watch on their wrist
subject with electrical stimulation by pacemaker
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique AXIUM Centre de cardiologie | Aix-en-Provence | 13090 | France | |||
| Centre Cardiologique du Nord |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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frequency of adverse events
| 1 visit (30 minutes) |
| Saint-Denis |
| 93200 |
| France |