Evaluation of ECG Transmission and AI Models Using Apple Watch ECGs and Symptoms Data Collected Using a Mayo iPhone App
EvALuation of ECG Transmission and AI moDels Using Apple Watch ECGs and Symptoms Data Collected usiNg a Mayo iPhone App
EvALuation of ECG Transmission and AI moDels Using Apple Watch ECGs and Symptoms Data Collected usiNg a Mayo iPhone App
Sponsor study identifier
observational
4,163
1 country
1
Study Start
May 5, 2021
Actual (reported)Primary Completion
July 9, 2024
Actual (reported)Study Completion
July 9, 2024
Actual (reported)The purpose of the study is to determine if the Electrocardiograms (ECGs) and symptoms data obtained from an Apple Watch and transmitted to Mayo Clinic are of sufficient quality to guide a person's care.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 9, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 5, 2021
Actual (reported)March 22, 2022
Actual (reported)April 12, 2022
Actual (reported)July 9, 2024
Actual (reported)July 9, 2024
Actual (reported)Number of patient-triggered Apple Watch ECGs recorded
Total number of patient-triggered Apple Watch ECGs recorded and uploaded by individual patients over the study period.
12 months
Frequency of medical providers accessing Apple Watch data
Number of times a medical provider accesses the Apple Watch data via electronic medical record-linked ECG dashboard.
12 months
Number of Apple Watch ECGs of acceptable quality
A sample of Apple Watch ECGs will undergo manual review by ECG technicians and rated using a standard data form for signal quality and diagnostic utility, summarized as the percent of "acceptable" ECGs.
12 months
Patients who own an Apple Watch series 4 or later willing to record and upload personal ECGs to our study App
Patients in the general public who own ECG-capable Apple Watches
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Paul Friedman, MD
Mayo Clinic
4,163 participants (actual enrollment reported by the registry).
First Submitted
March 22, 2022
First Posted
April 12, 2022
Study Start
May 5, 2021
Actual (reported)Apple Watch Heart Failure Study
Performance of Artificial Intelligence ECG algorithms for disease prediction with Apple Watch ECGs
Artificial Intelligence ECG algorithms to predict various cardiac pathologies will be applied to Apple Watch ECGs. Accuracy and performance of AI algorithm models will be assessed by comparing AI predicted disease and patient's given medical diagnosis in the electronic medical record.
12 months
Contact the study team to confirm eligibility.
Primary Completion
July 9, 2024
Actual (reported)Study Completion
July 9, 2024
Actual (reported)Last Updated
September 19, 2024
Record last verified: 2024-09
Due to patient confidentiality and IRB rules, we will not make individual patient data available
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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