Atrial Fibrillation
Conditions
Keywords
mHealth, Atrial fibrillation
Brief summary
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
Interventions
ECG recording with investigational device
Sponsors
Syntactx
Withings
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female who are 22 years of age or older, * Subject able to read, understand, and provide written informed consent, * Subject willing and able to participate in the study procedures as described in the consent form, * Subject able to communicate effectively with and willing to follow instructions from the study staff.
Exclusion criteria
* Vulnerable subject with regard to regulations in force * Subject who is deprived of liberty by judicial, medical or administrative decision, * Underage subject, * Legally protected subject, or subject who is unable, linguistic or psychic incapacity, to sign the written informed consent form. * Subject within several of the above categories, * Subject who refused to participate in the study, * Subject mentally impaired resulting in limited ability to cooperate * Subject with electrical stimulation by pacemaker * Patient with pathologic disorder that may affect motricity resulting in significant tremor that prevents subject from being able to hold still (e.g Parkinson disease) * Patient unable to stay in an upright position for the duration of study measures * Acute myocardial infarction (MI) within 90 days of screening or other cardiovascular disease that, in the opinion of the Investigator, may increase the risk to the subject or renders data uninterpretable (e.g., recent or ongoing unstable angina, decompensated heart failure, active myocarditis or pericarditis) * Acute pulmonary embolism or pulmonary infarction, within 90 days of screening * Stroke or transient ischemic attack within 90 days of screening * Active life-threatening rhythms as determined by the investigator (ventricular tachycardia, ventricular fibrillation, 3 rd -degree heart block). * History of life-threatening rhythms as determined by the investigator (ventricular tachycardia, ventricular fibrillation, 3 rd -degree heart block) * Symptomatic (or active) allergic skin reactions such as eczema, rosacea, impetigo, dermatomyositis or allergic contact dermatitis over electrode attachment sites * Known sensitivity to medical adhesives, isopropyl alcohol, or electrocardiogram (ECG) electrodes including known allergy or sensitivity to fluoroelastomer bands * Weight more than 180 kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Co-primary outcomes | 4 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 SUT, compared to the reference 12-lead ECG. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the classification into heart rate subgroups | 4 months | 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 |
| Clinical Equivalence of ECG waveforms | 4 months | 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), |
| Heart Rate equivalence | 4 months | 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 |
Countries
France, United States
Outcome results
None listed