<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03798613</url>
  </required_header>
  <id_info>
    <org_study_id>18-1397</org_study_id>
    <nct_id>NCT03798613</nct_id>
  </id_info>
  <brief_title>Accuracy of the Apple Watch Series 4 for Detection of Heart Rhythm: A Pilot Study</brief_title>
  <official_title>Accuracy of the Apple Watch Series 4 for Detection of Heart Rhythm: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Case Western Reserve University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to assess the accuracy of the Apple Watch 4 Series watch in&#xD;
      generating an ECG that is suitable for determination of heart rhythm compared to rhythms&#xD;
      monitored via telemetry. Secondary objective is to assess the accuracy of the Apple Watch 4&#xD;
      series watch in identifying atrial fibrillation when it is present.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will assess the accuracy of the Apple watch 4 series watch when worn by&#xD;
      post-operative cardiac surgery patients after they have transferred from the ICU to the&#xD;
      cardiac telemetry unit.&#xD;
&#xD;
      During testing each subject will wear:&#xD;
&#xD;
        1. An Apple Watch 4 series watch for no more than 5 minutes.&#xD;
&#xD;
        2. Standard continuous telemetry monitor&#xD;
&#xD;
      The location of the watch (left or right wrist) will be randomly assigned.&#xD;
&#xD;
      Heart rate and rhythm will be assessed by obtaining tracings from the Apple Watch 4 series&#xD;
      watch while at the same point in time obtaining tracings from a standard telemetry monitor.&#xD;
&#xD;
      ECGs from the Apple Watch 4 will be collected by asking the patient to place his/ her finger&#xD;
      on the digital crown of the Apple Watch 4 for 30 seconds. The rhythm displayed by the Apple&#xD;
      Watch 4 will be viewed on the Apple health app (available on the iPhone 8) and will be saved&#xD;
      for subsequent viewing and analysis.&#xD;
&#xD;
      Each enrolled patient will have a minimum of three assessments of heart rhythm per day for at&#xD;
      least two days, generating a minimum of six data points per patient.&#xD;
&#xD;
      After conclusion of the study for each subject, the ECG's from the health app pertaining to&#xD;
      that subject will be reviewed by a board certified cardiologist as will the telemetry&#xD;
      tracings.&#xD;
&#xD;
      In order to obtain tracings of new onset post-operative atrial fibrillation. 50% of the&#xD;
      subjects enrolled will be in sinus rhythm and 50% will be in atrial fibrillation at the time&#xD;
      of enrollment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2018</start_date>
  <completion_date type="Actual">March 29, 2019</completion_date>
  <primary_completion_date type="Actual">March 29, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Heart rate accuracy compared to telemetry</measure>
    <time_frame>5 minutes</time_frame>
    <description>Apple Watch 4 Series heart rate monitor device accuracy compared to standard continuous telemetry monitor. This will be expressed by the correlation coefficient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart rhythm accuracy compared to telemetry</measure>
    <time_frame>5 minutes</time_frame>
    <description>Apple Watch 4 Series heart rhythm device accuracy compared to standard continuous telemetry monitor. This will be expressed by the correlation coefficient.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Heart Rate Fast</condition>
  <condition>Heart Rate Low</condition>
  <arm_group>
    <arm_group_label>Apple Watch 4 Series Device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Apple watch 4 series heart rate monitoring device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Continuous Telemetry</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard continuous telemetry monitoring device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Apple Watch 4 Series Device</intervention_name>
    <description>tracings from the apple watch 4 series watch</description>
    <arm_group_label>Apple Watch 4 Series Device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous Telemetry Monitor</intervention_name>
    <description>tracings from the continuous telemetry monitor</description>
    <arm_group_label>Continuous Telemetry</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Post-operative cardiac surgery patients on the cardiac telemetry floors at the&#xD;
             Cleveland Clinic Main Campus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of a cardiac pacemaker&#xD;
&#xD;
          -  Use of a radial artery graft for coronary artery bypass grafting&#xD;
&#xD;
          -  Tattoos located on the skin of the wrist or forearm where the Apple Watch 4 will be&#xD;
             placed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc Gillinov, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>April 5, 2019</last_update_submitted>
  <last_update_submitted_qc>April 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Marc Gillinov, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Post-op Atrial Fibrillation</keyword>
  <keyword>Heart Rhythm</keyword>
  <keyword>Accuracy</keyword>
  <keyword>Apple Watch</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tachycardia</mesh_term>
    <mesh_term>Bradycardia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03798613
org study id: 18-1397
nct id: NCT03798613
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Factorial Assignment
primary purpose: Other
masking: None (Open Label)
measure: Heart rate accuracy compared to telemetry
time frame: 5 minutes
description: Apple Watch 4 Series heart rate monitor device accuracy compared to standard continuous telemetry monitor. This will be expressed by the correlation coefficient.
measure: Heart rhythm accuracy compared to telemetry
time frame: 5 minutes
description: Apple Watch 4 Series heart rhythm device accuracy compared to standard continuous telemetry monitor. This will be expressed by the correlation coefficient.
arm group label: Apple Watch 4 Series Device
arm group type: Active Comparator
description: Apple watch 4 series heart rate monitoring device
arm group label: Continuous Telemetry
arm group type: Active Comparator
description: Standard continuous telemetry monitoring device
intervention type: Device
intervention name: Apple Watch 4 Series Device
description: tracings from the apple watch 4 series watch
arm group label: Apple Watch 4 Series Device
intervention type: Device
intervention name: Continuous Telemetry Monitor
description: tracings from the continuous telemetry monitor
arm group label: Continuous Telemetry
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc Gillinov, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Marc Gillinov, MD
investigator title: Principal Investigator
mesh term: Tachycardia
mesh term: Bradycardia