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

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.

Study Overview

• Status: Completed
• Conditions: Heart Rate Fast; Heart Rate Low
• Intervention / Treatment: Device: Apple Watch 4 Series Device; Device: Continuous Telemetry Monitor

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Case Western Reserve University
• Investigators: Principal Investigator: Marc Gillinov, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2018
• Primary Completion (Actual): March 29, 2019
• Study Completion (Actual): March 29, 2019

Study Registration Dates

• First Submitted: December 21, 2018
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (Actual): January 10, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 5, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Accuracy; Apple Watch; Heart Rhythm; Post-op Atrial Fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Bradycardia; Tachycardia
• Other Study ID Numbers: 18-1397

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No