Exploratory Study of Apple Watch Electrocardiographic Diagnostic Performance Enhanced by an Artificial Intelligence Algorithm
Étude Exploratoire Des Performances de Diagnostic Électrocardiographique de l'Apple Watch augmentée d'un Algorithme d'Intelligence Artificielle
1 other identifier
observational
200
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 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
March 8, 2021
CompletedFirst Posted
Study publicly available on registry
March 11, 2021
CompletedStudy Start
First participant enrolled
March 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 19, 2021
CompletedSeptember 8, 2021
September 1, 2021
4 months
March 8, 2021
September 7, 2021
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 patients having cardiac rhythm consultation and who have expressed non-opposition 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 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
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
March 8, 2021
First Posted
March 11, 2021
Study Start
March 30, 2021
Primary Completion
July 19, 2021
Study Completion
July 19, 2021
Last Updated
September 8, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share