Atrial Fibrillation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTECG measurement
Simultaneous recording of a single-lead ECG signal with the Withings Move ECG and ECG signal for the reference 12-lead ECG
Sponsors
Withings
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male or female who are 18 years or older * Subject who signed the written informed consent form
Exclusion criteria
* Vulnerable subject with regard to regulations * Pregnant, parturient or breastfeeding woman, * Subject who is deprived of liberty by judicial, medical or administrative decision, * Underage subject, * Legally protected subject, or subject who is unable to sign the written informed consent form, * Subject who is not beneficiary or not affiliated to a social security scheme, * Subject within several of the above categories, * Subject who refused to participate in the study, * Subject in physical incapacity to wear a wrist-worn watch * Subject with electrical stimulation by pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and Specificity of the automatic classification in AF by Move ECG single-lead ECG against reference 12-lead ECG | 1 year | sensitivity from the 2x2 confusion matrix AF vs 'non-AF' |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparability of ECG waveforms from single strip of Move ECG vs Lead-1 of reference 12-lead ECG | 1 year | Visibility and polarity of P waves, QRS complex and T waves + length of QT interval, QRS width and PR interval + heart rate |
| Safety of use of Move ECG | 1 year | Frequency of adverse event appearance |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORJulien Nahum
Centre Cardiologique du Nord
Outcome results
None listed