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CompletedNCT04792905Updated Sep 8, 2021

Exploratory Study of Apple Watch Electrocardiographic Diagnostic Performance Enhanced by an Artificial Intelligence 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 2021-09-08.

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 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)

Read the 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.

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Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 200 is below the median of 300 across 1,363 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 patients having cardiac rhythm consultation and who have expressed non-opposition 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 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

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

    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.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2021, 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
NCT04792905
Lead sponsor
Cardiologs Technologies
Responsible party
Sponsor
First posted
Mar 11, 2021
Start date
Mar 30, 2021
Primary completion
Jul 19, 2021
Completion
Jul 19, 2021
Last update
Sep 8, 2021

Study contacts

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

Oversight

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 Sep 2021. You cannot join it, but the record below documents what was studied.

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