Cleveland Clinic
Cleveland, Ohio, 44195, United States
NCT Number: NCT03798613
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44195, United States
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
tracings from the apple watch 4 series watch
tracings from the continuous telemetry monitor
Time frame: 5 minutes
Apple Watch 4 Series heart rate monitor device accuracy compared to standard continuous telemetry monitor. This will be expressed by the correlation coefficient.
Time frame: 5 minutes
Apple Watch 4 Series heart rhythm device accuracy compared to standard continuous telemetry monitor. This will be expressed by the correlation coefficient.
The Cleveland Clinic
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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