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

Primary Purpose

Heart Rate Fast, Heart Rate Low

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Apple Watch 4 Series Device
Continuous Telemetry Monitor
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Rate Fast focused on measuring Post-op Atrial Fibrillation, Heart Rhythm, Accuracy, Apple Watch

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Apple Watch 4 Series Device

Continuous Telemetry

Arm Description

Apple watch 4 series heart rate monitoring device

Standard continuous telemetry monitoring device

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 21, 2018
Last Updated
April 5, 2019
Sponsor
The Cleveland Clinic
Collaborators
Case Western Reserve University
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1. Study Identification

Unique Protocol Identification Number
NCT03798613
Brief Title
Accuracy of the Apple Watch Series 4 for Detection of Heart Rhythm: A Pilot Study
Official Title
Accuracy of the Apple Watch Series 4 for Detection of Heart Rhythm: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 21, 2018 (Actual)
Primary Completion Date
March 29, 2019 (Actual)
Study Completion Date
March 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
Case Western Reserve University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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: An Apple Watch 4 series watch for no more than 5 minutes. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Rate Fast, Heart Rate Low
Keywords
Post-op Atrial Fibrillation, Heart Rhythm, Accuracy, Apple Watch

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apple Watch 4 Series Device
Arm Type
Active Comparator
Arm Description
Apple watch 4 series heart rate monitoring device
Arm Title
Continuous Telemetry
Arm Type
Active Comparator
Arm Description
Standard continuous telemetry monitoring device
Intervention Type
Device
Intervention Name(s)
Apple Watch 4 Series Device
Intervention Description
tracings from the apple watch 4 series watch
Intervention Type
Device
Intervention Name(s)
Continuous Telemetry Monitor
Intervention Description
tracings from the continuous telemetry monitor
Primary Outcome Measure Information:
Title
Heart rate accuracy compared to telemetry
Description
Apple Watch 4 Series heart rate monitor device accuracy compared to standard continuous telemetry monitor. This will be expressed by the correlation coefficient.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Heart rhythm accuracy compared to telemetry
Description
Apple Watch 4 Series heart rhythm device accuracy compared to standard continuous telemetry monitor. This will be expressed by the correlation coefficient.
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Gillinov, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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

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