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

Atrial Fibrillation Clinical Trial

Official title:

Investigation Clinique Observationnelle Des Performances de Diagnostic Electrocardiographique de l'Apple Watch (App ECG Version 2.0) augmentée d'un Algorithme d'Intelligence Artificielle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05045456
• Other study ID #: AI Watch2
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation

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