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 1. The presence or absence of atrial fibrillation 2. if waveforms of ECG recorded with Move ECG compared with the reference.
Study Type
OBSERVATIONAL
Enrollment
234
Simultaneous recording of a single-lead ECG signal with the Withings Move ECG and ECG signal for the reference 12-lead ECG
Institut Cœur Paris Centre Turin
Paris, Île-de-France Region, France
Hopital Europeen Georges Pompidou
Paris, Île-de-France Region, France
Centre Cardiologique du Nord
Saint-Denis, Île-de-France Region, France
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'
Time frame: 1 year
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
Time frame: 1 year
Safety of use of Move ECG
Frequency of adverse event appearance
Time frame: 1 year
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