Accuracy of the Apple Watch Series 4 for Detection of Heart Rhythm: A Pilot Study
NCT ID: NCT03798613
Last Updated: 2019-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2018-12-21
2019-03-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
OTHER
NONE
Study Groups
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Apple Watch 4 Series Device
Apple watch 4 series heart rate monitoring device
Apple Watch 4 Series Device
tracings from the apple watch 4 series watch
Continuous Telemetry
Standard continuous telemetry monitoring device
Continuous Telemetry Monitor
tracings from the continuous telemetry monitor
Interventions
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Apple Watch 4 Series Device
tracings from the apple watch 4 series watch
Continuous Telemetry Monitor
tracings from the continuous telemetry monitor
Eligibility Criteria
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Inclusion Criteria
* Post-operative cardiac surgery patients on the cardiac telemetry floors at the Cleveland Clinic Main Campus
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Case Western Reserve University
OTHER
The Cleveland Clinic
OTHER
Responsible Party
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Marc Gillinov, MD
Principal Investigator
Principal Investigators
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Marc Gillinov, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic
Cleveland, Ohio, United States
Countries
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Other Identifiers
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18-1397
Identifier Type: -
Identifier Source: org_study_id
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