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

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT04792905
• Lead Sponsor: Cardiologs Technologies

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.

Study Timeline

• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2021-03-08
• Study First Posted: 2021-03-11
• Study Start: 2021-03-30
• Primary Completion: 2021-07-19
• Study Completion: 2021-07-19
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-08

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 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

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