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



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/12/2019
Start Date:December 21, 2018
End Date:May 2019
Contact:Marc Gillinov, MD
Email:GILLINOM@ccf.org
Phone:216 445-8841

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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.

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:

1. An Apple Watch 4 series watch for no more than 5 minutes.

2. 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.

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
We found this trial at
1
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Phone: 216-445-1647
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