NCT03798613

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

December 21, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2019

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

December 21, 2018

Last Update Submit

April 5, 2019

Conditions

Heart Rate FastHeart Rate Low

Keywords

Post-op Atrial FibrillationHeart RhythmAccuracyApple Watch

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Heart rhythm accuracy compared to telemetry

    5 minutes

Study Arms (2)

Apple Watch 4 Series Device

ACTIVE COMPARATOR

Apple watch 4 series heart rate monitoring device

Device: Apple Watch 4 Series Device

Continuous Telemetry

ACTIVE COMPARATOR

Standard continuous telemetry monitoring device

Device: Continuous Telemetry Monitor

Interventions

Apple Watch 4 Series DeviceDEVICE

tracings from the apple watch 4 series watch

Apple Watch 4 Series Device
Continuous Telemetry MonitorDEVICE

tracings from the continuous telemetry monitor

Continuous Telemetry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Post-operative cardiac surgery patients on the cardiac telemetry floors at the Cleveland Clinic Main Campus

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

TachycardiaBradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marc Gillinov, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 21, 2018

First Posted

January 10, 2019

Study Start

December 21, 2018

Primary Completion

March 29, 2019

Study Completion

March 29, 2019

Last Updated

April 9, 2019

Record last verified: 2019-04

Locations

US(1)