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Withings Move ECG watch is designed to record ECG and detect automatically atrial fibrillation. The aim of this study is to validate the performance of Move ECG watch to detect atrial fibrillation compared to a reference 12-lead ECG.
Patients with atrial fibrillation are included in hospitals. On each patient, ECG with Move ECG and the reference 12-lead ECG are recorded simultaneously. Both records are then reviewed by independent cardiologists to assess
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| atrial fibrillation (AF) | Patients diagnosed with AF during reference ECG |
| |
| sinus rhythm (SR) | Patients diagnosed with SR during reference ECG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECG measurement | Diagnostic Test | Simultaneous recording of a single-lead ECG signal with the Withings Move ECG and ECG signal for the reference 12-lead ECG |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of the automatic classification in AF by Move ECG single-lead ECG against reference 12-lead ECG | sensitivity from the 2x2 confusion matrix AF vs 'non-AF' | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Comparability of ECG waveforms from single strip of Move ECG vs Lead-1 of reference 12-lead ECG | Visibility and polarity of P waves, QRS complex and T waves + length of QT interval, QRS width and PR interval + heart rate | 1 year |
| Safety of use of Move ECG |
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Inclusion Criteria:
Exclusion Criteria:
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in and out patients from cardiology services
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| Name | Affiliation | Role |
|---|---|---|
| Julien Nahum | Centre Cardiologique du Nord | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Cœur Paris Centre Turin | Paris | Île-de-France Region | 75008 | France | ||
| Hopital Europeen Georges Pompidou |
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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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Frequency of adverse event appearance |
| 1 year |
| Paris |
| Île-de-France Region |
| 75015 |
| France |
| Centre Cardiologique du Nord | Saint-Denis | Île-de-France Region | 93200 | France |
| D013568 |
| Pathological Conditions, Signs and Symptoms |