Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection

Study Overview
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Brief Summary
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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.

Detailed Description
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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 The presence or absence of atrial fibrillation if waveforms of ECG recorded with Move ECG compared with the reference.

Official Title
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Clinical Performance of Withings Move ECG Software for Atrial Fibrillation Detection

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Diagnostic Test: ECG measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female who are 18 years or older Subject who signed the written informed consent form Exclusion Criteria: Vulnerable subject with regard to regulations Pregnant, parturient or breastfeeding woman, Subject who is deprived of liberty by judicial, medical or administrative decision, Underage subject, Legally protected subject, or subject who is unable to sign the written informed consent form, Subject who is not beneficiary or not affiliated to a social security scheme, Subject within several of the above categories, Subject who refused to participate in the study, Subject in physical incapacity to wear a wrist-worn watch Subject with electrical stimulation by pacemaker

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| atrial fibrillation (AF)<br>Patients diagnosed with AF during reference ECG | Diagnostic Test: ECG measurement<br>* Simultaneous recording of a single-lead ECG signal with the Withings Move ECG and ECG signal for the reference 12-lead ECG<br>|
| sinus rhythm (SR)<br>Patients diagnosed with SR during reference ECG | Diagnostic Test: ECG measurement<br>* Simultaneous recording of a single-lead ECG signal with the Withings Move ECG and ECG signal for the reference 12-lead ECG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Frequency of adverse event appearance | 1 year |