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OpenTrials
Completed

NCT Number: NCT05045456

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

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)

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier

Massy, 91300, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiologs Platform

Device

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

Other names: Apple Watch

Primary outcomes

  1. Performance of AF detection

    Time frame: 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 outcomes

  1. AW versus AI-AW

    Time frame: 1 day

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

  2. AI-AW versus AI-12lead

    Time frame: 1 day

    Comparison of the performance of AF detection by AI-AW and AI applied to the 12-lead ECG

Sponsors and collaborators

Lead sponsor

Cardiologs Technologies

Industry

Registry information

Official study title

Investigation Clinique Observationnelle Des Performances de Diagnostic Electrocardiographique de l'Apple Watch (App ECG Version 2.0) augmentée d'un Algorithme d'Intelligence Artificielle

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2021
Registry last updated
Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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