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

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ClinicalTrials.gov Identifier: NCT04792905
Recruitment Status : Completed
First Posted : March 11, 2021
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment
Atrial Fibrillation Device: Cardiologs

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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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Étude Exploratoire Des Performances de Diagnostic Électrocardiographique de l'Apple Watch augmentée d'un Algorithme d'Intelligence Artificielle
Actual Study Start Date : March 30, 2021
Actual Primary Completion Date : July 19, 2021
Actual Study Completion Date : July 19, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Cardiologs
    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 Name: Apple Watch


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04792905


Locations
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France
Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier
Massy, France, 91300
Sponsors and Collaborators
Cardiologs Technologies
Investigators
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Principal Investigator: Laurent Fiorina, Dr Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier
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Responsible Party: Cardiologs Technologies
ClinicalTrials.gov Identifier: NCT04792905    
Other Study ID Numbers: AI Watch
First Posted: March 11, 2021    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes