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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05045456
Other study ID # AI Watch2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 9, 2021
Est. completion date February 23, 2022

Study information

Verified date March 2022
Source Cardiologs Technologies
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date February 23, 2022
Est. primary completion date February 23, 2022
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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

Locations

Country Name City State
France Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier Massy

Sponsors (1)

Lead Sponsor Collaborator
Cardiologs Technologies

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 day
Secondary AW versus AI-AW Comparison of Apple Watch (AW) and AI-AW AF detection performance 1 day
Secondary AI-AW versus AI-12lead Comparison of the performance of AF detection by AI-AW and AI applied to the 12-lead ECG 1 day
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