<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/NCT04441892</url>
  </required_header>
  <id_info>
    <org_study_id>18-006014</org_study_id>
    <nct_id>NCT04441892</nct_id>
  </id_info>
  <brief_title>Low Cost QTc Meter for Long QT Syndrome Screening in Primary Care</brief_title>
  <official_title>Phase II Novel Low Cost QTc Meter for Long QT Syndrome Screening in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Blue Ox Health Corporation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Minnesota Health Solutions</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>iCardiac Technologies</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to further develop and evaluate a diagnostic procedure suitable&#xD;
      for use in an inexpensive diagnostic instrument suitable for screening for Long QT Syndrome&#xD;
      (LQTS) in the primary care environment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will involve acquiring ECG data in a cohort of up to 1,000 newborns and infants&#xD;
      (500 controls (non-LQTS) and 500 LQTS newborns and infants) that are being seen in the Gonda&#xD;
      SL ECG Lab (or Baldwin Building)and enrolled during their appointment for a clinically&#xD;
      indicated 12-lead ECG. A second arm of Phase II of this study will include approaching 50&#xD;
      healthy subjects at the Baldwin Building to seek interest in participation which will consist&#xD;
      of (1) 30 second device recording to help further calibrate and test the device for optimal&#xD;
      enhancement. These 50 subjects will not be required to have a clinical or research 12-lead&#xD;
      ECG as the investigators will be simply testing the efficiency and accuracy of the device.&#xD;
      LQTS will be studied in order to assess the ability of the LQTS screener to accurately detect&#xD;
      a patient with established QT prolongation in the context of distinct and varied T wave&#xD;
      morphologies The advanced prototype will be placed in the same manner as the device used in&#xD;
      Phase I of the study by being lightly placed on the child as pictured below. Similarly, the&#xD;
      investigators will use ultrasound gel to obtain a better reading, if applicable. Once&#xD;
      completed, a photograph of the torso of the child will be taken from the same views as before&#xD;
      (one aerial view and one side view) with neither the head nor the face in the picture. Coded&#xD;
      ECG-tracings will be transmitted to the app and shared with Blue Ox Health Corporation and&#xD;
      Minnesota Health Solutions as done previously in phase I. Additionally, coded tracings and&#xD;
      data from the 12-lead ECG will be shared with Blue Ox Health Corporation and Minnesota Health&#xD;
      Solutions to aid in comparison to device tracings and optimization of the algorithm. The&#xD;
      12-lead ECG will be obtained from the subject's medical record and coded before being shared&#xD;
      with collaborators. Study coordinators will also review the patient's medical record to&#xD;
      determine whether the participants have been diagnosed with a genetic disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID, lack of funding and interruption of patient recruitment led to ending the study early.&#xD;
  </why_stopped>
  <start_date type="Actual">February 7, 2019</start_date>
  <completion_date type="Actual">March 26, 2020</completion_date>
  <primary_completion_date type="Actual">March 26, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Low Cost QTc Meter for Long QT Syndrome Screening</measure>
    <time_frame>Baseline</time_frame>
    <description>Number of subjects to have a successful tracing recorded with the QTc Meter in Participants with or without Long QT Syndrome between the ages of 0 and 5</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Long QT Syndrome</condition>
  <arm_group>
    <arm_group_label>QTc Meter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>QTc Meter - Healthy Controls</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>QTc Meter</intervention_name>
    <description>Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.</description>
    <arm_group_label>QTc Meter</arm_group_label>
    <arm_group_label>QTc Meter - Healthy Controls</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants (Day 0 - 5 years).&#xD;
&#xD;
          -  Long QT Syndrome(LQTS).&#xD;
&#xD;
          -  Newborns without LQTS (Controls).&#xD;
&#xD;
          -  Parental willingness to provide informed consent and follow the study protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children &gt; 5 years old.&#xD;
&#xD;
          -  Those with genetically elusive LQTS.&#xD;
&#xD;
          -  Infants with congenital heart disease.&#xD;
&#xD;
          -  Infants born &lt; 32 weeks EGA.&#xD;
&#xD;
          -  Patients with a cardiac device implant (pacemaker/ICD).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Ackerman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <results_first_submitted>March 20, 2023</results_first_submitted>
  <results_first_submitted_qc>July 6, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 25, 2023</results_first_posted>
  <last_update_submitted>July 6, 2023</last_update_submitted>
  <last_update_submitted_qc>July 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Michael J. Ackerman</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Long QT Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 24, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT04441892/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>QTc Meter</title>
          <description>Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device&#xD;
QTc Meter: Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.</description>
        </group>
        <group group_id="P2">
          <title>QTc Meter - Healthy Controls</title>
          <description>Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device.&#xD;
QTc Meter: Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>QTc Meter</title>
          <description>Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device&#xD;
QTc Meter: Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.</description>
        </group>
        <group group_id="B2">
          <title>QTc Meter - Healthy Controls</title>
          <description>Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device.&#xD;
QTc Meter: Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="28"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="33"/>
          </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="2.2" spread="1.5"/>
                    <measurement group_id="B2" value="2.8" spread="1.6"/>
                    <measurement group_id="B3" value="2.2" spread="1.5"/>
                  </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="15"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="28"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Low Cost QTc Meter for Long QT Syndrome Screening</title>
        <description>Number of subjects to have a successful tracing recorded with the QTc Meter in Participants with or without Long QT Syndrome between the ages of 0 and 5</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>QTc Meter</title>
            <description>Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device&#xD;
QTc Meter: Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.</description>
          </group>
          <group group_id="O2">
            <title>QTc Meter - Healthy Controls</title>
            <description>Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device.&#xD;
QTc Meter: Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.</description>
          </group>
        </group_list>
        <measure>
          <title>Low Cost QTc Meter for Long QT Syndrome Screening</title>
          <description>Number of subjects to have a successful tracing recorded with the QTc Meter in Participants with or without Long QT Syndrome between the ages of 0 and 5</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from baseline to end of study participation for a total of approximately 1 day on all participants.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>QTc Meter</title>
          <description>Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device&#xD;
QTc Meter: Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.</description>
        </group>
        <group group_id="E2">
          <title>QTc Meter - Healthy Controls</title>
          <description>Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device.&#xD;
QTc Meter: Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.</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="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Last patient enrolled in February of 2020. Enrollment was paused because of stay-at-home COVID mandates and even when general clinical operations resumed, elective clinical studies like these were not immediately resumed in the ECG monitoring lab to limit the number of people around patients. By the time recruitment could resume, the collaborating company had run out of funding for the study and the study was terminated. Study only enrolled 33 participates out of anticipated 1050.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Michael J. Ackerman</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-284-8900</phone>
      <email>ackerman.michael@mayo.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/NCT04441892
org study id: 18-006014
nct id: NCT04441892
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to further develop and evaluate a diagnostic procedure suitable
      for use in an inexpensive diagnostic instrument suitable for screening for Long QT Syndrome
      (LQTS) in the primary care environment.
The study will involve acquiring ECG data in a cohort of up to 1,000 newborns and infants
      (500 controls (non-LQTS) and 500 LQTS newborns and infants) that are being seen in the Gonda
      SL ECG Lab (or Baldwin Building)and enrolled during their appointment for a clinically
      indicated 12-lead ECG. A second arm of Phase II of this study will include approaching 50
      healthy subjects at the Baldwin Building to seek interest in participation which will consist
      of (1) 30 second device recording to help further calibrate and test the device for optimal
      enhancement. These 50 subjects will not be required to have a clinical or research 12-lead
      ECG as the investigators will be simply testing the efficiency and accuracy of the device.
      LQTS will be studied in order to assess the ability of the LQTS screener to accurately detect
      a patient with established QT prolongation in the context of distinct and varied T wave
      morphologies The advanced prototype will be placed in the same manner as the device used in
      Phase I of the study by being lightly placed on the child as pictured below. Similarly, the
      investigators will use ultrasound gel to obtain a better reading, if applicable. Once
      completed, a photograph of the torso of the child will be taken from the same views as before
      (one aerial view and one side view) with neither the head nor the face in the picture. Coded
      ECG-tracings will be transmitted to the app and shared with Blue Ox Health Corporation and
      Minnesota Health Solutions as done previously in phase I. Additionally, coded tracings and
      data from the 12-lead ECG will be shared with Blue Ox Health Corporation and Minnesota Health
      Solutions to aid in comparison to device tracings and optimization of the algorithm. The
      12-lead ECG will be obtained from the subject's medical record and coded before being shared
      with collaborators. Study coordinators will also review the patient's medical record to
      determine whether the participants have been diagnosed with a genetic disease.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Low Cost QTc Meter for Long QT Syndrome Screening
time frame: Baseline
description: Number of subjects to have a successful tracing recorded with the QTc Meter in Participants with or without Long QT Syndrome between the ages of 0 and 5
arm group label: QTc Meter
arm group type: Experimental
description: Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device
arm group label: QTc Meter - Healthy Controls
arm group type: Experimental
description: Infants/Children (Day 0-Age 5) will participate in this study as minimal risk. Patients will record 30 seconds of data that is collected on the QTc Screening device.
intervention type: Device
intervention name: QTc Meter
description: Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.
arm group label: QTc Meter
arm group label: QTc Meter - Healthy Controls
criteria: 
gender: All
minimum age: N/A
maximum age: 5 Years
healthy volunteers: No
last name: Michael Ackerman, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Michael J. Ackerman
investigator title: Principal Investigator
mesh term: Long QT Syndrome
mesh term: Syndrome
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Last patient enrolled in February of 2020. Enrollment was paused because of stay-at-home COVID mandates and even when general clinical operations resumed, elective clinical studies like these were not immediately resumed in the ECG monitoring lab to limit the number of people around patients. By the time recruitment could resume, the collaborating company had run out of funding for the study and the study was terminated. Study only enrolled 33 participates out of anticipated 1050.
point of contact: 