Evaluation of ECG Transmission & AI Models Using Apple Watch ECGs &

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

1. Patients who have the Mayo Clinic patient app and iOS 14 or higher who are 18 years of age or older will be invited to enroll. 2. Patient will undergo email survey to assess ownership of Apple Watch v4 or later, and subsequent willingness to participate in the study. Those who agree will undergo digital consent and enrollment. 3. A customized Mayo Clinic Study App will be available to download to their iOS device and will be used to test whether it is feasible to access ECGs and symptoms data patients have collected using their personal Apple watch that are saved on the patient's phone. The study app will facilitate transmission of past and future patient-recorded watch ECGs. 4. The patient ECGs and self-reported symptoms data will be uploaded to the AI Dashboard in the patient's medical record (ECG rhythm classification facilitated by Apple ECG program). 5. We will perform a retrospective review of electronic medical record data from enrolled subjects to assess the quality of the Apple Watch obtained ECGs, assess the results from the AI-ECG dashboard using obtained watch ECGs, and compare these results to prior or subsequently obtained 12 lead ECGs. 6. Data analysis will be performed with steps to ensure patient confidentiality. Data will be transmitted using similar protocols as with current app data, and all data will be saved in the secure Mayo Clinic electronic environment (called the UDP). 7. All patients' watch data will be compared to AI dashboard data. Additionally, clinical data in the EMR (such as blood tests, echocardiograms, and other data recorded for routine medical care) will be used to assess the utility of the watch ECG quality for AI algorithms (such as determining whether a weak heart pump is present, for example). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05324566
Study type	Observational [Patient Registry]
Source	Mayo Clinic
Contact	Jennifer Dugan, BA
Phone	507-538-1125
Email	dugan.jennifer@mayo.edu
Status	Recruiting
Phase
Start date	May 5, 2021
Completion date	June 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluation of ECG Transmission and AI Models Using Apple Watch ECGs and Symptoms Data Collected Using a Mayo iPhone App

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms