Accuracy of the Apple Watch Series 4 for Detection of Heart Rhythm: A Pilot Study

Study Overview
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Brief Summary
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The objective of this study is to assess the accuracy of the Apple Watch 4 Series watch in generating an ECG that is suitable for determination of heart rhythm compared to rhythms monitored via telemetry. Secondary objective is to assess the accuracy of the Apple Watch 4 series watch in identifying atrial fibrillation when it is present.

Detailed Description
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The study will assess the accuracy of the Apple watch 4 series watch when worn by post-operative cardiac surgery patients after they have transferred from the ICU to the cardiac telemetry unit. During testing each subject will wear: An Apple Watch 4 series watch for no more than 5 minutes. Standard continuous telemetry monitor The location of the watch (left or right wrist) will be randomly assigned. Heart rate and rhythm will be assessed by obtaining tracings from the Apple Watch 4 series watch while at the same point in time obtaining tracings from a standard telemetry monitor. ECGs from the Apple Watch 4 will be collected by asking the patient to place his/ her finger on the digital crown of the Apple Watch 4 for 30 seconds. The rhythm displayed by the Apple Watch 4 will be viewed on the Apple health app (available on the iPhone 8) and will be saved for subsequent viewing and analysis. Each enrolled patient will have a minimum of three assessments of heart rhythm per day for at least two days, generating a minimum of six data points per patient. After conclusion of the study for each subject, the ECG's from the health app pertaining to that subject will be reviewed by a board certified cardiologist as will the telemetry tracings. In order to obtain tracings of new onset post-operative atrial fibrillation. 50% of the subjects enrolled will be in sinus rhythm and 50% will be in atrial fibrillation at the time of enrollment.

Official Title
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Accuracy of the Apple Watch Series 4 for Detection of Heart Rhythm: A Pilot Study

Conditions
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Heart Rate Fast, Heart Rate Low

Intervention / Treatment
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* Device: Apple Watch 4 Series Device
* Device: Continuous Telemetry Monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Post-operative cardiac surgery patients on the cardiac telemetry floors at the Cleveland Clinic Main Campus Exclusion Criteria: Presence of a cardiac pacemaker Use of a radial artery graft for coronary artery bypass grafting Tattoos located on the skin of the wrist or forearm where the Apple Watch 4 will be placed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Apple Watch 4 Series Device<br>Apple watch 4 series heart rate monitoring device | Device: Apple Watch 4 Series Device<br>* tracings from the apple watch 4 series watch<br>|
| Active Comparator: Continuous Telemetry<br>Standard continuous telemetry monitoring device | Device: Continuous Telemetry Monitor<br>* tracings from the continuous telemetry monitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate accuracy compared to telemetry | Apple Watch 4 Series heart rate monitor device accuracy compared to standard continuous telemetry monitor. This will be expressed by the correlation coefficient. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rhythm accuracy compared to telemetry | Apple Watch 4 Series heart rhythm device accuracy compared to standard continuous telemetry monitor. This will be expressed by the correlation coefficient. | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-op Atrial Fibrillation, Heart Rhythm, Accuracy, Apple Watch