Performance and Accuracy of an AI Enhanced Smart Watch Single Lead ECG

Completed

• Conditions: Healthy

• Registration Number: NCT05450809
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to show the artificial intelligence enhanced single-lead ECG Apple Watch has similar, robust performance comparable to an AI enhanced 12 lead ECG and AI enhanced single lead (LI) of a 12 lead ECG.

Detailed Description

1. Ambulatory patients undergoing ECG recording in the Mayo Clinic outpatient ECG lab will be asked to consent for this study.

2. Those who consent for the study will be asked to record a ECG using a single-lead watch-based (Apple Watch series 5) recording at a visit for a clinically scheduled 12 lead ECG recording.

3. This watch-based ECG data will be recorded and analyzed in comparison to the near-simultaneously recorded outpatient 12 Lead ECG

Study Timeline

• Study Start: 2021-11-05
• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-07-05
• Study First Posted: 2022-07-11
• Primary Completion: 2022-11-02
• Study Completion: 2022-11-02
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-27
• Last Update Posted: 2022-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Age ≥ 18 years and ≤ 89.
• Able to give verbal consent.
• Able to complete routine clinical 12 lead ECG tracing and single lead Apple Watch ECG tracing.

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Exclusion Criteria

• Individuals < 18 and > 89 years of age.
• Unable to given verbal consent.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of 12 lead ECG features to single-lead watch-based ECG features	12 months	The ECG interval differences (in milliseconds) between 12 Lead and collected single-lead watch-based ECG for PR, QRS, QT intervals will be determined and compared for each patient.
Arrhythmia comparison of 12 lead ECG to single-lead watch-based ECG	12 months	A physician interpretation of patients' 12 lead ECG and single-lead watch-based ECG will be performed to determined underlying rhythm (i.e. sinus rhythm, atrial fibrillation etc) from each, and the results from these modalities will be compared.

Secondary Outcome Measures

Name	Time	Method
Arrhythmia classification by physician overread of single-lead watch-based ECG	12 months	A physician interpretation of the patient's single-lead watch-based ECG will occur as described in "Outcome 2." The results of this ECG interpretation (i.e. sinus rhythm, atrial fibrillation, or inconclusive) will be compared to the watch/app-based rhythm auto-classification for each recorded single-lead watch-based ECG.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States