Observational Clinical Investigation of EKG Diagnostic Performance of the Apple Watch Augmented With an AI Algorithm

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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Investigation Clinique Observationnelle Des Performances de Diagnostic Electrocardiographique de l'Apple Watch (App ECG Version 2.0) augmentée d'un Algorithme d'Intelligence Artificielle

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Cardiologs Platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 22 or older, able and willing to participate in the study Patient admitted to hospital for ablation, cardioversion or cardiac electrophysiological exploration or who comes for regular rhythmology consultations or hospitalized in cardiology department Patient who has read the information note and has given his or her consent before any procedure related to the study Patient affiliated to social security Exclusion Criteria: Pregnant or breastfeeding women Patient with a pacemaker, implantable defibrillator or cardiac resynchronisation therapy device. Subject related to the investigator or any other staff member directly involved in the conduct of the study Patient incapable of giving consent, minor or adult patient protected by law

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cardiologs Platform|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 1 day |