<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/NCT02977104</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00074138</org_study_id>
    <nct_id>NCT02977104</nct_id>
  </id_info>
  <brief_title>Maestro Handheld Cardiac Monitor Validation</brief_title>
  <official_title>Maestro Handheld Cardiac Monitor Validation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</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 purpose of this study is to demonstrate that the Maestro hand held heart monitor can&#xD;
      accurately diagnose Atrial Fibrillation, atrial flutter or normal sinus rhythm in patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine if Maestro can be used to detect heart arrhythmias,&#xD;
      specifically atrial fibrillation in humans. Maestro will be used to measure heart rate and&#xD;
      rhythm at the same time that patients are being monitored with a standard 3, 5, or 12 lead&#xD;
      electrocardiogram (ECG) in a clinical setting. The recorded Maestro results will be compared&#xD;
      to the ECG results to assess Maestro's accuracy.&#xD;
&#xD;
      Data will be analyzed by a pass/fail criterial. The data will be downloaded and printed for&#xD;
      the investigators' interpretation who will first review and code the data from Meastro,&#xD;
      blinded to the ECG findings. Then the investigators will interpret the ECG findings and the 2&#xD;
      sets of data will be compared. The ECG result is the true value with which to compare the&#xD;
      Maestro result.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2013</start_date>
  <completion_date type="Actual">December 5, 2017</completion_date>
  <primary_completion_date type="Actual">December 5, 2017</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>
    <intervention_model_description>40 subjects with Atrial Fibrillation 10 subjects with Atrial Flutter 20 subjects with Sinus Rhythm</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity and Specificity of atrial fibrillation detection</measure>
    <time_frame>6 seconds</time_frame>
    <description>Each sample acquired by the Maestro system will be automatically analyzed and rhythm categorized by the automated algorithm. This will then be assessed for accuracy and sensitivity and specificity for detection of atrial fibrillation will be calculated.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Cardiac Arrhythmia</condition>
  <arm_group>
    <arm_group_label>Patients in afib or flutter</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Maestro ECG</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients in sinus rhythm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Maestro ECG</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Maestro ECG</intervention_name>
    <description>Telemetry is obtained through the Maestro handheld ECG device.</description>
    <arm_group_label>Patients in afib or flutter</arm_group_label>
    <arm_group_label>Patients in sinus rhythm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ability to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  implanted pacemakers&#xD;
&#xD;
          -  open wounds or abrasions on their hands&#xD;
&#xD;
          -  prior damage to hands or thumbs precluding obtaining an ECG tracing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rakesh Latchamsetty, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan Cardiovascular Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</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>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>December 6, 2017</last_update_submitted>
  <last_update_submitted_qc>December 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Rakesh Latchamsetty</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</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/NCT02977104
org study id: HUM00074138
nct id: NCT02977104
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to demonstrate that the Maestro hand held heart monitor can
      accurately diagnose Atrial Fibrillation, atrial flutter or normal sinus rhythm in patients.
The purpose of this study is to determine if Maestro can be used to detect heart arrhythmias,
      specifically atrial fibrillation in humans. Maestro will be used to measure heart rate and
      rhythm at the same time that patients are being monitored with a standard 3, 5, or 12 lead
      electrocardiogram (ECG) in a clinical setting. The recorded Maestro results will be compared
      to the ECG results to assess Maestro's accuracy.

      Data will be analyzed by a pass/fail criterial. The data will be downloaded and printed for
      the investigators' interpretation who will first review and code the data from Meastro,
      blinded to the ECG findings. Then the investigators will interpret the ECG findings and the 2
      sets of data will be compared. The ECG result is the true value with which to compare the
      Maestro result.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: 40 subjects with Atrial Fibrillation 10 subjects with Atrial Flutter 20 subjects with Sinus Rhythm
primary purpose: Diagnostic
masking: None (Open Label)
measure: Sensitivity and Specificity of atrial fibrillation detection
time frame: 6 seconds
description: Each sample acquired by the Maestro system will be automatically analyzed and rhythm categorized by the automated algorithm. This will then be assessed for accuracy and sensitivity and specificity for detection of atrial fibrillation will be calculated.
arm group label: Patients in afib or flutter
arm group type: Other
description: Maestro ECG
arm group label: Patients in sinus rhythm
arm group type: Other
description: Maestro ECG
intervention type: Other
intervention name: Maestro ECG
description: Telemetry is obtained through the Maestro handheld ECG device.
arm group label: Patients in afib or flutter
arm group label: Patients in sinus rhythm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rakesh Latchamsetty, MD
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Rakesh Latchamsetty
investigator title: Assistant Professor
mesh term: Arrhythmias, Cardiac
sharing ipd: No