The aim of the study is to evaluate the performance of Withings WBS08 with embedded Withings ECG Monitor in the automatic detection of atrial fibrillation
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
650
ECG recording with investigational device
ECG recording with reference device
FWD Clinical Research
Boca Raton, Florida, United States
Florida Cardiovascular Research
Hialeah, Florida, United States
Diverse Clinical Research
Miami, Florida, United States
Co-primary outcomes
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 SUT, compared to the reference 12-lead ECG.
Time frame: 4 months
Co-primary outcomes
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 SUT, compared to the reference 12-lead ECG.
Time frame: 4 months
Evaluation of the classification into heart rate subgroups
The classification into heart rate subgroups will be evaluated for the 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 SUT is classified as either SR or AF. The evaluation will be assessed with the concordance of classifications, i.e. the percentage P of identical classifications by the SUT and the reference method, into each of the four following subgroups: * SR with a HR between 50 and 99 bpm * SR with a HR between 100 and 150 bpm * AF with a HR between 50 and 99 bpm * AF with a HR between 100 and 150 bpm
Time frame: 4 months
Clinical Equivalence of ECG waveforms
Clinical Equivalence of ECG waveforms will be qualitatively and quantitatively assessed between the 6-leads generated by the SUT and the leads I, II, III, aVR, aVL, aVF of the 12-lead ECG by a board of certified cardiologists: The visibility and polarity of the P waves, QRS complexes and T waves will be determined by cardiologists and according to a set of predetermined rules. For each type of wave (P, QRS and T),
Time frame: 4 months
Clinical Equivalence of ECG waveforms
The durations of the QT intervals, QRS complex widths, and PR intervals will be measured by cardiologists with a caliper and according to a set of predetermined rules for each of the 6 leads of the strips generated by the SUT and the leads I, II, III, aVR, aVL, aVF of the 12-lead ECG.
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The Angel Medical Research
Miami Lakes, Florida, United States
American Institute of Therapeutics
Lake Bluff, Illinois, United States
Cambridge Medical Trials
Alexandria, Louisiana, United States
Heartbeat Health
New York, New York, United States
Texas Heart Institute
Houston, Texas, United States
LINQ Research LLC
Pearland, Texas, United States
Henri-Mondor Hospital
Créteil, Île-de-France Region, France
Time frame: 4 months
Heart Rate equivalence
heart rate will be determined by independent cardiologists, or cardiac technicians supervised by cardiologists, from each six-channel strip recorded with the SUT and from each lead I, II, III, aVR, aVL, aVF of the 12-lead reference ECG
Time frame: 4 months