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The aim of the study is to demonstrate the performance of Withings WBS08 in the automatic identification of atrial fibrillation and sinus rhythm.
Patients included will be those presenting for consultation in the various participating clinical services. For each patient, an ECG will be recorded with the WBS08 and with the reference device Cardiovit FT1, at rest and after an exercise session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Withings WBS08 and 12-lead reference ECG | Experimental | The electrodes of the 12-lead ECG will be set up on the participants, before they step on withings WBS08 to have ECGs simultaneously recorded by the study device and the control device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Validation of the Withings bodyscan scale WBS08 | Device | Participants will undergo simultaneous recordings of ECGs with the comparator and the study device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance in the identification of atrial fibrillation and sinus rhythm | The co-primary endpoints are the sensitivity and specificity 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. | 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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 :
|
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Inclusion Criteria:
For subjects enrolled into the AF population, subjects must have a known diagnosis of AF and be in AF at the time of screening. Subjects may have any type of AF including paroxysmal, persistent, and permanent AF.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Lellouche, MD | Henri Mondor University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires de Bruxelles - Hôpital Erasme | Brussels | 1070 | Belgium | |||
| Henri Mondor University Hospital |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 10 months |
| Assessment of the 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. | 10 months |
| Assessment of the 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 on the first beat of the 6 marked PQRST complexes 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. | 10 months |
| Determination of the heart rate | The 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 strip of the reference ECG. For each simultaneous pair of strips, a reviewer will independently select a common lead with the best signal quality. Then, the reviewer will determine one or several window(s) on the selected lead according to a set of predetermined rules. Finally the number N of complete RR intervals inside these windows and the duration Dt (< 30s) of the windows will be measured with a caliper. The heart rate will then be calculated as 60*N/Dt. The reader-estimated heart rates will later be compared to the heart rates calculated by the SUT | 10 months |
| Créteil |
| Val De Marne |
| 94000 |
| France |
| Poitiers University Hospital | Poitiers | Vienne | 86021 | France |
| George Pompidou European Hospital | Paris | 75015 | France |
| D013568 |
| Pathological Conditions, Signs and Symptoms |