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

Cardiologs Technologies200 enrolled

Overview

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)

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Atrial Fibrillation

Interventions

Cardiologs PlatformDEVICE

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

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier

Massy, France

Outcomes

Primary Outcomes

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

Time frame: 1 day

Secondary Outcomes

AW versus AI-AW

Comparison of Apple Watch (AW) and AI-AW AF detection performance

Time frame: 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

Time frame: 1 day

Data from ClinicalTrials.gov

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