Observational Clinical Investigation of EKG Diagnostic Performance of the Apple Watch Augmented With an AI Algorithm
Investigation Clinique Observationnelle Des Performances de Diagnostic Electrocardiographique de l'Apple Watch (App ECG Version 2.0) augmentée d'un Algorithme d'Intelligence Artificielle
1 other identifier
observational
200
1 country
1
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2021
CompletedFirst Posted
Study publicly available on registry
September 16, 2021
CompletedStudy Start
First participant enrolled
November 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2022
CompletedMarch 3, 2022
March 1, 2022
4 months
September 7, 2021
March 2, 2022
Conditions
Outcome Measures
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
1 day
Secondary Outcomes (2)
AW versus AI-AW
1 day
AI-AW versus AI-12lead
1 day
Interventions
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
Eligibility Criteria
200 participants: patients hospitalized for ablation or cardioversion or in cardiology department or patients having cardiac rhythm consultation and who have consented to participate to the study
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier
Massy, 91300, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent Fiorina, Dr
Institut Cardiologique Paris Sud Hôpital Privé Jacques Cartier
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2021
First Posted
September 16, 2021
Study Start
November 9, 2021
Primary Completion
February 23, 2022
Study Completion
February 23, 2022
Last Updated
March 3, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share