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

Atrial Fibrillation Clinical Trial

Official title:

Étude Exploratoire Des Performances de Diagnostic Électrocardiographique de l'Apple Watch augmentée d'un Algorithme d'Intelligence Artificielle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04792905
• Other study ID #: AI Watch
• Status: Completed
• Start date: March 30, 2021
• Est. completion date: July 19, 2021

Study information

• Verified date: September 2021
• Source: Cardiologs Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 19, 2021
• Est. primary completion date: July 19, 2021
• 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 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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

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