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This observational prospective clinical investigation will evaluate the performance on an Artificial Intelligence (AI) solution interpreting ECG (electrocardiogram) collected from an Apple Watch (AI-AW) in the detection of Atrial Fibrillation (AF)
Each patient hospitalized for ablation or cardioversion and having given consent to participate in the clinical investigation will have ECG recordings by Apple Watch performed simultaneously with a 12D ECG measurement by a cardiologist before and/or after treatment, in accordance with the existing patient monitoring protocol. Similarly, patients attending a rhythmology consultation or hospitalized in the cardiology department will have simultaneous ECG recordings with an Apple Watch during the scheduled routine 12D ECG recording.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiologs Platform | Device | Two Apple Watch recordings (one recording with the watch on the wrist and one on the left side of the abdomen) interpreted by Cardiologs AI done simultaneously with each 12-lead ECG |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance of AF detection | Performance of AF detection by an artificial intelligence (AI) solution interpreting ECG collected via Apple Watches (AI-AW), compared to physician's diagnosis from the 12 leads ECG | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| AW versus AI-AW | Comparison of Apple Watch (AW) and AI-AW AF detection performance | 1 day |
| AI-AW versus AI-12lead | Comparison of the performance of AF detection by AI-AW and AI applied to the 12-lead ECG |
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Inclusion Criteria:
Exclusion Criteria:
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200 participants: patients hospitalized for ablation or cardioversion or in cardiology department or patients having cardiac rhythm consultation and who have consented to participate to the study
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Fiorina, Dr | Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier | Massy | 91300 | France |
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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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| 1 day |
| D013568 |
| Pathological Conditions, Signs and Symptoms |