Heart Rate Fast, Heart Rate Low
Conditions
Keywords
Post-op Atrial Fibrillation, Heart Rhythm, Accuracy, Apple Watch
Brief summary
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
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.
Interventions
DEVICEApple Watch 4 Series Device
tracings from the apple watch 4 series watch
DEVICEContinuous Telemetry Monitor
tracings from the continuous telemetry monitor
Sponsors
Case Western Reserve University
The Cleveland Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate accuracy compared to telemetry | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rhythm accuracy compared to telemetry | 5 minutes | Apple Watch 4 Series heart rhythm device accuracy compared to standard continuous telemetry monitor. This will be expressed by the correlation coefficient. |
Countries
United States
Outcome results
None listed