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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-09

Study Completion Date

2022-02-23

Brief Summary

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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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Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Cardiologs Platform

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

Intervention Type DEVICE

Other Intervention Names

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Apple Watch

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No