Étude Exploratoire Des Performances de Diagnostic Électrocardiographique de l'Apple Watch augmentée d'un Algorithme d'Intelligence Artificielle
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Cardiologs Technologies
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Performance of AF detection
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Performance of AF detection
Time Frame: 1 day
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
Secondary Outcomes
- AW versus AI-AW(1 day)
- AI-AW versus AI-12lead(1 day)