<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/NCT03769207</url>
  </required_header>
  <id_info>
    <org_study_id>1.2</org_study_id>
    <secondary_id>48787</secondary_id>
    <nct_id>NCT03769207</nct_id>
  </id_info>
  <brief_title>Evaluation of the Use of Apple Watch Features for Identification of Cardiac Arrhythmias</brief_title>
  <official_title>Evaluation of the Use of Apple Watch Features for Identification of Cardiac Arrhythmias</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Apple Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Apple Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This post-marketing study is conducted to characterize the ability of Apple Watch rhythm&#xD;
      analysis software to identify Atrial Fibrillation (AF) and facilitate subsequent clinical&#xD;
      evaluation among users who contact AppleCare.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 8, 2018</start_date>
  <completion_date type="Actual">August 20, 2019</completion_date>
  <primary_completion_date type="Actual">July 5, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration</measure>
    <time_frame>During ambulatory ECG Monitoring (up to 8 days)</time_frame>
    <description>Detected on ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arrhythmias Other Than AF</measure>
    <time_frame>During ambulatory ECG Monitoring (up to 8 days)</time_frame>
    <description>Detected on an ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported Contact With Healthcare Provider</measure>
    <time_frame>Between 15 to 90 days following enrollment</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Arrhythmias, Cardiac</condition>
  <condition>Atrial Flutter</condition>
  <arm_group>
    <arm_group_label>Ambulatory ECG</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ambulatory ECG</intervention_name>
    <description>Eligible participants are asked to wear the ambulatory ECG monitor</description>
    <arm_group_label>Ambulatory ECG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Possession of the following at time of eligibility screening:&#xD;
&#xD;
               -  iPhone (5s or later) with iOS version 12.1.1 or later defined as iPhone model/iOS&#xD;
                  version used to complete screening eligibility.&#xD;
&#xD;
               -  Apple Watch (Series 1-4) with watchOS version 5.1.2 or later defined as Apple&#xD;
                  Watch model/watchOS paired with iPhone used to complete screening eligibility&#xD;
&#xD;
          2. At least one of the following by self-report before consent:&#xD;
&#xD;
               -  Irregular Rhythm Notification&#xD;
&#xD;
               -  ECG app classification of Atrial Fibrillation&#xD;
&#xD;
               -  ECG app classification of Inconclusive defined as &quot;Inconclusive,&quot; &quot;Heart Rate&#xD;
                  Over 120,&quot; or &quot;Heart Rate Under 50&quot;&#xD;
&#xD;
          3. Age ≥ 22 years at time of eligibility screening&#xD;
&#xD;
          4. Current resident of the United States at time of eligibility screening, and will&#xD;
             reside in the United States for the length of the study&#xD;
&#xD;
          5. Proficient in written and spoken English&#xD;
&#xD;
          6. Valid phone number associated with iPhone, ascertained from self-report&#xD;
&#xD;
          7. Valid email address, ascertained from self-report&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Shared iCloud account&#xD;
&#xD;
          2. Shared AppleWatch&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marco V Perez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Minang (Mintu) Turakhia, MD, MAS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <results_first_submitted>September 25, 2020</results_first_submitted>
  <results_first_submitted_qc>September 25, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 20, 2020</results_first_posted>
  <last_update_submitted>September 25, 2020</last_update_submitted>
  <last_update_submitted_qc>September 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Marco Perez</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine (Cardiovascular Medicine)</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
    <mesh_term>Atrial Flutter</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03769207/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants who received an irregular pulse notification or who had an AF classification on the ECG app and then called the sponsor's customer support were invited to download the study app and enroll. They had a remote study visit, were sent an ECG patch to wear and return for analysis, and had a second remote visit to review the findings.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Ambulatory ECG</title>
          <description>Ambulatory ECG: Eligible participants are asked to wear the ambulatory ECG monitor</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Attended First Study Visit</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>ECG Patch Shipped</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>ECG Patch Returned and Readable</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Attended Second Study Visit</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ambulatory ECG</title>
          <description>Ambulatory ECG: Eligible participants are asked to wear the ambulatory ECG monitor</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="17"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.4" spread="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Middle Eeastern or North African</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Preferred not to respond</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration</title>
        <description>Detected on ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification</description>
        <time_frame>During ambulatory ECG Monitoring (up to 8 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ambulatory ECG</title>
            <description>Ambulatory ECG: Eligible participants are asked to wear the ambulatory ECG monitor</description>
          </group>
        </group_list>
        <measure>
          <title>Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration</title>
          <description>Detected on ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification</description>
          <units>Proportion of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" lower_limit="0.003" upper_limit="0.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Arrhythmias Other Than AF</title>
        <description>Detected on an ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification</description>
        <time_frame>During ambulatory ECG Monitoring (up to 8 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ambulatory ECG</title>
            <description>Ambulatory ECG: Eligible participants are asked to wear the ambulatory ECG monitor</description>
          </group>
        </group_list>
        <measure>
          <title>Arrhythmias Other Than AF</title>
          <description>Detected on an ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification</description>
          <units>Proportion of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-reported Contact With Healthcare Provider</title>
        <time_frame>Between 15 to 90 days following enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ambulatory ECG</title>
            <description>Ambulatory ECG: Eligible participants are asked to wear the ambulatory ECG monitor</description>
          </group>
        </group_list>
        <measure>
          <title>Self-reported Contact With Healthcare Provider</title>
          <units>Proportion of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.56" lower_limit="0.21" upper_limit="0.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>9 months (participants may have reported adverse events at any time from enrollment to close of study)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Ambulatory ECG</title>
          <description>Ambulatory ECG: Eligible participants are asked to wear the ambulatory ECG monitor</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Elevated Heart Rate</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The small number of enrolled participants prevents us from drawing meaningful conclusions from this study.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Marco Perez, Associate Professor of Medicine</name_or_title>
      <organization>Stanford University</organization>
      <phone>(650) 723-9363</phone>
      <email>mvperez@stanford.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03769207
org study id: 1.2
secondary id: 48787
nct id: NCT03769207
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This post-marketing study is conducted to characterize the ability of Apple Watch rhythm
      analysis software to identify Atrial Fibrillation (AF) and facilitate subsequent clinical
      evaluation among users who contact AppleCare.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration
time frame: During ambulatory ECG Monitoring (up to 8 days)
description: Detected on ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification
measure: Arrhythmias Other Than AF
time frame: During ambulatory ECG Monitoring (up to 8 days)
description: Detected on an ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification
measure: Self-reported Contact With Healthcare Provider
time frame: Between 15 to 90 days following enrollment
arm group label: Ambulatory ECG
arm group type: Other
intervention type: Device
intervention name: Ambulatory ECG
description: Eligible participants are asked to wear the ambulatory ECG monitor
arm group label: Ambulatory ECG
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marco V Perez, MD
role: Principal Investigator
affiliation: Stanford University
last name: Minang (Mintu) Turakhia, MD, MAS
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Marco Perez
investigator title: Assistant Professor of Medicine (Cardiovascular Medicine)
mesh term: Atrial Fibrillation
mesh term: Arrhythmias, Cardiac
mesh term: Atrial Flutter
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The small number of enrolled participants prevents us from drawing meaningful conclusions from this study.
point of contact: 