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

Cardiologs Technologies

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: Cardiologs Platform

Study type: Observational

Funder types: Industry

Identifiers

NCT05045456

AI Watch2

Details and patient eligibility

About

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)

Full description

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.

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 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