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

Cardiologs Technologies

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: Cardiologs

Study type: Observational

Funder types: Industry

Identifiers

NCT04792905

AI Watch

Details and patient eligibility

About

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)

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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