Heart Rate Fast Clinical Trial
Official title:
Accuracy of the Apple Watch Series 4 for Detection of Heart Rhythm: A Pilot Study
Verified date | April 2019 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | March 29, 2019 |
Est. primary completion date | March 29, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic | Case Western Reserve University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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