The aim of the study is to evaluate the performance of Withings SCT02 with embedded Withings ECG-app in the automatic detection of atrial fibrillation
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
373
30 second ECG recording with investigational device (Withings SCT02)
30 second ECG recording with reference device (Schiller Cardiovit FT-1)
FWD Clinical Research
Boca Raton, Florida, United States
Diverse Clinical Research
Miami, Florida, United States
Henri Mondor University Hospital
Créteil, Val de Marne, France
Centre Cardiopole Trubert
Paris, France
Co-primary outcome 1 - Sensitivity of Investigational Device
Sensitivity (percentage of true positives) in detecting AF from conclusive recordings generated by the software under test, that is recordings resulting in a classification of AF or SR by the IMD, compared to the reference 12-lead ECG.
Time frame: 10 months
Co-primary outcome 2 - Specificity of Investigational Device
Specificity (percentage of true negatives) in detecting AF from conclusive recordings generated by the software under test, that is recordings resulting in a classification of AF or SR by the IMD, compared to the reference 12-lead ECG.
Time frame: 10 months
Rhythm classification by ranges of heart rate
On pairs of strips such that the rhythm classification of the 12-lead ECG is either SR or AF and such that the strip generated by the IMD is classified as either SR or AF, the classification into four heart rate subgroups will be evaluated. * Sinus Rhythm, (50-99 bpm) * High Heart Rate (No signs of AFib) (100-150 bpm) * Atrial Fibrillation (50-99 bpm), * Atrial Fibrillation (100-150 bpm)
Time frame: 10 months
Quality of plots measured by the IMD - ECG Waveform Visibility
Clinical Equivalence of ECG waveforms will be qualitatively and quantitatively assessed between the 1-lead generated by the IMD and the lead I of the 12-lead reference ECG determined by certified cardiologists. Equivalence will be evaluated by FV : Fraction of concordant assessments of visibility between the IMD and the reference
Time frame: 10 months
Quality of plots measured by the IMD - ECG Waveforms Polarity
On waveforms with waves that are Visible, Clinical Equivalence of ECG waveforms will be qualitatively and quantitatively assessed between the 1-lead generated by the IMD and the lead I of the 12-lead reference ECG determined by certified cardiologists. Equivalence will be evaluated by FP : Fraction of concordant assessment of polarity between IMD and reference
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Time frame: 10 months
Quality of plots measured by the IMD - ECG Waveforms Intervals
Determine the equivalence of PR, QRS and QT intervals durations between the lead I of the IMD and the lead I of the reference ECG determined by an independent board of certified cardiologists. Duration error will be calculated.
Time frame: 10 months
Quality of plots measured by the IMD - Heart Rate calculation
Determine the equivalence of the heart rate (HR) calculated by the IMD and the HR measured by an independent board of certified cardiologists or cardiology technicians on the ECG of the reference.
Time frame: 10 months