<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/NCT04468477</url>
  </required_header>
  <id_info>
    <org_study_id>CD20/130832</org_study_id>
    <nct_id>NCT04468477</nct_id>
  </id_info>
  <brief_title>EVALECGcardio Study</brief_title>
  <official_title>An Evaluation of the Safety and Clinical Utility of Handheld ECG Technology in Cardiology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Leeds Teaching Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Leeds Teaching Hospitals NHS Trust</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>
      ECGs are routinely performed in cardiology. Recently handheld ECGs have shown promise in&#xD;
      screening for heart rhythm disorders. These are quick to perform and do not require the&#xD;
      preparation that is needed for 12 lead ECGs. We wanted to test whether a novel handheld ECG&#xD;
      recorder, Kardia 6L, which has the potential to record a 6 lead ECG is able to screen for ECG&#xD;
      abnormalities, thereby obviating the need for a full 12 lead ECG. This may allow for earlier&#xD;
      diagnosis and treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of analysis is to determine if the handheld 6 lead ECG can be used as a simple&#xD;
      screener to identify patients who do not need a 12 lead ECG.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 29, 2020</start_date>
  <completion_date type="Anticipated">May 21, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 21, 2021</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>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference between the 6 lead and the 12 lead Electrocardiogram</measure>
    <time_frame>2 minutes</time_frame>
    <description>Sensitivity and specificity of handheld 6Lead compared to 12lead for the measurement of the stages of heart rhythms.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">750</enrollment>
  <condition>Cardiac Arrhythmia</condition>
  <arm_group>
    <arm_group_label>Patients attending cardiac outpatient clinic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>6 Lead ECG</intervention_name>
    <description>Patients will be assessed with the Kardiamobile device.</description>
    <arm_group_label>Patients attending cardiac outpatient clinic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anyone attending cardiology outpatients or the ward who has had a recent ECG (within 6&#xD;
             hours)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not consent to the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Leeds Teaching Hospitals NHS Trust</name>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Muzahir Tayebjee, MBChB MRCP MD</last_name>
      <email>muzahir.tayebjee@nhs.net</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</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/NCT04468477
org study id: CD20/130832
nct id: NCT04468477
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
ECGs are routinely performed in cardiology. Recently handheld ECGs have shown promise in
      screening for heart rhythm disorders. These are quick to perform and do not require the
      preparation that is needed for 12 lead ECGs. We wanted to test whether a novel handheld ECG
      recorder, Kardia 6L, which has the potential to record a 6 lead ECG is able to screen for ECG
      abnormalities, thereby obviating the need for a full 12 lead ECG. This may allow for earlier
      diagnosis and treatment.
The aim of analysis is to determine if the handheld 6 lead ECG can be used as a simple
      screener to identify patients who do not need a 12 lead ECG.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Difference between the 6 lead and the 12 lead Electrocardiogram
time frame: 2 minutes
description: Sensitivity and specificity of handheld 6Lead compared to 12lead for the measurement of the stages of heart rhythms.
arm group label: Patients attending cardiac outpatient clinic
arm group type: Active Comparator
intervention type: Device
intervention name: 6 Lead ECG
description: Patients will be assessed with the Kardiamobile device.
arm group label: Patients attending cardiac outpatient clinic
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac