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

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT05045456
• Lead Sponsor: Cardiologs Technologies

Brief Summary

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)

Detailed 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.

Study Timeline

• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-16
• Study Start: 2021-11-09
• Primary Completion: 2022-02-23
• Study Completion: 2022-02-23
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance of AF detection	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 Outcome Measures

Name	Time	Method
AW versus AI-AW	1 day	Comparison of Apple Watch (AW) and AI-AW AF detection performance
AI-AW versus AI-12lead	1 day	Comparison of the performance of AF detection by AI-AW and AI applied to the 12-lead ECG

Trial Locations

Locations (1)

Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier; 🇫🇷 Massy, France