Exploratory Study of Apple Watch Electrocardiographic Diagnostic Performance Enhanced by an Artificial Intelligence Algorithm

Study Overview
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Brief Summary
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This observational exploratory prospective study 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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After being informed about the study, participants hospitalized for ablation or cardioversion or having a cardiac rhythm consultation at the investigational center will have Apple Watch ECG recordings done simultaneously with 12-lead ECG measurements performed in accordance with the existing in-stay subject monitoring protocol. AI-AW will be compared to standard manual 12-lead ECG reviewed by cardiologists for AF detection.

Official Title
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Étude Exploratoire Des Performances de Diagnostic Électrocardiographique de l'Apple Watch augmentée d'un Algorithme d'Intelligence Artificielle

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Cardiologs


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 come for regular rhythmology consultations 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|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 |