<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/NCT02214069</url>
  </required_header>
  <id_info>
    <org_study_id>14-612</org_study_id>
    <nct_id>NCT02214069</nct_id>
  </id_info>
  <brief_title>Using Smart Phone Technology in Detecting the Presence of Atrial Fibrillation</brief_title>
  <acronym>iRead</acronym>
  <official_title>Assessing the Accuracy of an Atrial Fibrillation Detection Algorithm Using Novel Smart Phone Technology in Detecting the Presence of Atrial Fibrillation. iRead Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AliveCor</agency>
      <agency_class>Industry</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>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine whether patients can use the AliveCor case to record&#xD;
      their heart rhythm and to assess the accuracy of the software in detecting AF vs sinus rhythm&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      AliveCor is a new monitoring technology used with a smart phone which allows patients to&#xD;
      record their rhythm. The study will compare AliveCor recordings and automated interpretation&#xD;
      of the rhythm with the interpretation by an Electrophysiologist.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Examine the accuracy of the AliveCor software in detecting AF or sinus rhythm compared to the physician interpretation</measure>
    <time_frame>6 month</time_frame>
    <description>Both the software nd overreading electrophysiologist come to the same conclusion regarding the rhythm of the ECG and Alivecor reading. Both determining that the tracing is either normal sinus rhythm or atrial fibrillation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess the correlation between QT interval derived from the AliveCor device compared to standard 12 lead ECG, as assessed by the overreading electrophysiologists.</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Atrial Flutter</condition>
  <arm_group>
    <arm_group_label>Patients with Atrial Fibrillation</arm_group_label>
    <description>Patients with Atrial Fibrillation admitted to the hospital for drug loading with Dofetilide or Sotalol willing to record and transmit heart rhythm using AliveCor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Record and transmit heart rhythm</intervention_name>
    <description>The patient uses the AliveCor device to record and transmit heart rhythm two times a day. The patient, device software, and Electrophysiologist interpret the rhythm</description>
    <arm_group_label>Patients with Atrial Fibrillation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to the hospital for your atrial fibrillation or atrial flutter&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female between &gt; 18 and &lt; 80 years of age&#xD;
&#xD;
          2. Paroxysmal or persistent atrial fibrillation&#xD;
&#xD;
          3. Admitted for antiarrhythmic drug loading (Dofetilide or Sotalol)&#xD;
&#xD;
          4. Already has iPhone 4, 4S or 5 with data plan that accommodates the AliveCor case&#xD;
&#xD;
          5. Willing to use the Alive Cor case&#xD;
&#xD;
          6. Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unable or unwilling to use the Alive Cor case for their smart phone&#xD;
&#xD;
          2. Presence of a permanent pacemaker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Khaldoun Tarakji, 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>December 2017</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>December 11, 2017</last_update_submitted>
  <last_update_submitted_qc>December 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Khaldoun Tarakji</investigator_full_name>
    <investigator_title>Staff</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>Atrial Flutter</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02214069
org study id: 14-612
nct id: NCT02214069
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study is to examine whether patients can use the AliveCor case to record
      their heart rhythm and to assess the accuracy of the software in detecting AF vs sinus rhythm
AliveCor is a new monitoring technology used with a smart phone which allows patients to
      record their rhythm. The study will compare AliveCor recordings and automated interpretation
      of the rhythm with the interpretation by an Electrophysiologist.
observational model: Cohort
time perspective: Prospective
measure: Examine the accuracy of the AliveCor software in detecting AF or sinus rhythm compared to the physician interpretation
time frame: 6 month
description: Both the software nd overreading electrophysiologist come to the same conclusion regarding the rhythm of the ECG and Alivecor reading. Both determining that the tracing is either normal sinus rhythm or atrial fibrillation.
measure: Assess the correlation between QT interval derived from the AliveCor device compared to standard 12 lead ECG, as assessed by the overreading electrophysiologists.
time frame: 6 months
arm group label: Patients with Atrial Fibrillation
description: Patients with Atrial Fibrillation admitted to the hospital for drug loading with Dofetilide or Sotalol willing to record and transmit heart rhythm using AliveCor.
intervention type: Device
intervention name: Record and transmit heart rhythm
description: The patient uses the AliveCor device to record and transmit heart rhythm two times a day. The patient, device software, and Electrophysiologist interpret the rhythm
arm group label: Patients with Atrial Fibrillation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Khaldoun Tarakji, 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: Khaldoun Tarakji
investigator title: Staff
mesh term: Atrial Fibrillation
mesh term: Atrial Flutter
sharing ipd: No