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

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT03798613
• Collaborator: Case Western Reserve University (Other)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.2
• Patients Per Site Per Month: 15.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Rate Fast; Heart Rate Low	Device: Apple Watch 4 Series Device; Device: Continuous Telemetry Monitor	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Accuracy of the Apple Watch Series 4 for Detection of Heart Rhythm: A Pilot Study
• Actual Study Start Date: Dec 21, 2018
• Actual Primary Completion Date: Mar 29, 2019
• Actual Study Completion Date: Mar 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Apple Watch 4 Series Device Apple watch 4 series heart rate monitoring device	Device: Apple Watch 4 Series Device; tracings from the apple watch 4 series watch
Active Comparator: Continuous Telemetry Standard continuous telemetry monitoring device	Device: Continuous Telemetry Monitor; tracings from the continuous telemetry monitor

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic
• Case Western Reserve University

Investigators

• Principal Investigator: Marc Gillinov, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marc Gillinov, MD, Principal Investigator, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT03798613
• Other Study ID Numbers: 18-1397
• First Posted: Jan 10, 2019
• Last Update Posted: Apr 9, 2019
• Last Verified: Apr 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Marc Gillinov, MD, Principal Investigator, The Cleveland Clinic: Post-op Atrial Fibrillation; Heart Rhythm; Accuracy; Apple Watch
• Additional relevant MeSH terms: Tachycardia; Bradycardia

Study Results

No Results Posted as of Apr 9, 2019