Investigational Device (Withings SCT02) 30 second Electrocardiogram recording
Device30 second ECG recording with investigational device (Withings SCT02)
NCT Number: NCT06351761
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
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Notify Me22 year and older
All sexes
Interventional
Not applicable
Henri Mondor University Hospital, Créteil, Val de Marne, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
30 second ECG recording with investigational device (Withings SCT02)
30 second ECG recording with reference device (Schiller Cardiovit FT-1)
Time frame: 10 months
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
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
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.
Time frame: 10 months
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
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
Time frame: 10 months
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
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.
Withings
Industry
Validation of Withings BeamO With Withings ECG-App for the Detection of Atrial Fibrillation
Acronym: WIBOFA
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