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CompletedNCT05045456Updated Mar 3, 2022

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

An observational study in Atrial Fibrillation, sponsored by Cardiologs Technologies. Completed at 1 site in France. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2022-03-03.

Sponsored by Cardiologs Technologies · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
200
Ages
22 Years and older
Sex
All
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Study 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)

Read the 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.

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Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,869 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.

This study's enrollment of 200 is below the median of 300 across 1,362 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Cardiologs Technologies is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

200 participants: patients hospitalized for ablation or cardioversion or in cardiology department or patients having cardiac rhythm consultation and who have consented to participate to the study

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

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
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
200 participants (actual)
Patient registry
No

Interventions

  • DeviceCardiologs 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

    Also known as: Apple Watch

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What researchers measure

Primary outcomes

  1. 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

  1. AW versus AI-AW

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

    Time frame: 1 day

  2. 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

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Study locations

1 site
  • Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier
    Massy, 91300, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05045456
Lead sponsor
Cardiologs Technologies
Responsible party
Sponsor
First posted
Sep 16, 2021
Start date
Nov 9, 2021
Primary completion
Feb 23, 2022
Completion
Feb 23, 2022
Last update
Mar 3, 2022

Study contacts

Laurent Fiorina, Dr
principal investigator · Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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