xml: <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/NCT05970328</url>
    </required_header>
    <id_info>
      <org_study_id>HMS_ECG_external</org_study_id>
      <secondary_id>361070</secondary_id>
      <nct_id>NCT05970328</nct_id>
    </id_info>
    <brief_title>Hexoskin Medical System - ECG Performance Testing</brief_title>
    <official_title>HMS ECG Clinical Validation Study - Protocol External Site</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Carré Technologies Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Carré Technologies Inc.</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 goal of this observational study is to validate the efficacy of the Hexoskin Medical&#xD;
        System (HMS) for its intended use (i.e., manual assessment of cardiac rhythm disturbances) in&#xD;
        non-critical adult participants that are suspected of having an arrhythmia or have evidence&#xD;
        of arrhythmia requiring monitoring via 24-hour Holter monitor. The main question it aims to&#xD;
        answer are:&#xD;
  &#xD;
          1. Whether the HMS ECG recordings can be used to accurately detect cardiac beats when&#xD;
             compared with the Holter monitor&#xD;
  &#xD;
          2. Whether there are high correlations between the HMS and Holter monitor in ECG&#xD;
             characteristics&#xD;
  &#xD;
          3. Whether the HMS ECG recordings can be used to accurately classify cardiac rhythm/rhythm&#xD;
             disturbance when compared with the Holter monitor&#xD;
  &#xD;
          4. What is the accuracy of using HMS ECG recordings to detect cardiac beats&#xD;
  &#xD;
          5. What is the accuracy of using HMS ECG recordings to identify cardiac rhythm/rhythm&#xD;
             disturbance&#xD;
  &#xD;
        Participants will wear the HMS and the Holter monitor at the same time to record ECG signals.&#xD;
        Researchers will evaluate the ECG recordings acquired from both devices and assess the above&#xD;
        questions.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 24, 2023</start_date>
    <completion_date type="Anticipated">September 24, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 24, 2023</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>Cardiac beat detection agreement</measure>
      <time_frame>2 days</time_frame>
      <description>The level of agreement between using the HMS and the Holter monitor (reference standard) ECG recordings in detection of beats</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>ECG characteristics measurement agreement</measure>
      <time_frame>2 days</time_frame>
      <description>The agreement (as evidenced by establishment of a positive linear relationship) of Holter monitor(reference standard) and HMS to measure each of the eight (8) ECG Characteristics. ECG characteristics measured in this study include: RR Interval (ms), PR Interval (ms), PP Interval (ms), QRS Duration (ms), QRS Amplitude (mV), P Wave Duration (ms), P Wave Amplitude (mV), and QT Interval (ms).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiac rhythm outcome agreement</measure>
      <time_frame>2 days</time_frame>
      <description>The agreement of using Holter monitor (reference standard) and HMS ECG recordings to detect cardiac rhythms or rhythm disturbances.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiac beat detection accuracy</measure>
      <time_frame>2 days</time_frame>
      <description>The Sensitivity and Positive Predictive Value (PPV) of using the HMS ECG recordings to detect cardiac beats.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiac rhythm identification accuracy</measure>
      <time_frame>2 days</time_frame>
      <description>The Sensitivity and PPV of using the HMS ECG recordings to identify cardiac rhythm/rhythm disturbance.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Cardiac Rhythm Disturbance</condition>
    <arm_group>
      <arm_group_label>Arrhythmia Participant</arm_group_label>
      <description>Non-critical adult (21 years and older) participants that are suspected of having an arrhythmia or have evidence of arrhythmia requiring monitoring via 24-hour Holter monitor.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Hexoskin Medical System</intervention_name>
      <description>Participant wears both the Hexoskin Medical System and the Nasiff Holter Monitor at the same time to acquire ECG recordings.</description>
      <arm_group_label>Arrhythmia Participant</arm_group_label>
      <other_name>Nasiff Holter Monitor</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Consecutive patients consulting the cardiology clinics&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Provision of signed and dated informed consent form.&#xD;
  &#xD;
            -  Stated willingness to comply with all study procedures and availability for the&#xD;
               duration of the study.&#xD;
  &#xD;
            -  Male or female, aged 21 years or older.&#xD;
  &#xD;
            -  Participants must be suspected of having an arrhythmia or have evidence of arrhythmia&#xD;
               requiring monitoring via 24-hour Holter monitor.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Body circumference that is not covered by the HMS Shirt sizing chart&#xD;
  &#xD;
            -  Presence of pacemaker or Implantable Cardioverter-Defibrillator (ICD) devices&#xD;
  &#xD;
            -  Known allergic reactions to silver or polyamide/polyester/elastane&#xD;
  &#xD;
            -  Known allergic reactions to ECG gel electrodes&#xD;
  &#xD;
            -  Documented medical condition or illness requiring intensive medical treatment or care&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yutian Shu, Ph.D.</last_name>
      <phone>888-887-2044</phone>
      <email>yutian.shu@carretechnologies.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Lawrence Park Cardiology</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M4N 3N1</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Aynur Tremblay</last_name>
        <phone>416-882-1878</phone>
        <email>aynur@ycardiology.com</email>
      </contact>
      <investigator>
        <last_name>Christopher Cheung, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Eugene Crystal, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Yorkview Cardiology</name>
        <address>
          <city>North York</city>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Aynur Tremblay</last_name>
        <phone>416-882-1878</phone>
        <email>aynur@ycardiology.com</email>
      </contact>
      <investigator>
        <last_name>Christopher Cheung, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Eugene Crystal, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Hexoskin Medical System (HMS)</keyword>
    <keyword>Cardiac Rhythm Disturbance</keyword>
    <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>
      <ipd_description>There is no plan to make IPD available.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970328
  org study id: HMS_ECG_external
  secondary id: 361070
  nct id: NCT05970328
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to validate the efficacy of the Hexoskin Medical
        System (HMS) for its intended use (i.e., manual assessment of cardiac rhythm disturbances) in
        non-critical adult participants that are suspected of having an arrhythmia or have evidence
        of arrhythmia requiring monitoring via 24-hour Holter monitor. The main question it aims to
        answer are:
  
          1. Whether the HMS ECG recordings can be used to accurately detect cardiac beats when
             compared with the Holter monitor
  
          2. Whether there are high correlations between the HMS and Holter monitor in ECG
             characteristics
  
          3. Whether the HMS ECG recordings can be used to accurately classify cardiac rhythm/rhythm
             disturbance when compared with the Holter monitor
  
          4. What is the accuracy of using HMS ECG recordings to detect cardiac beats
  
          5. What is the accuracy of using HMS ECG recordings to identify cardiac rhythm/rhythm
             disturbance
  
        Participants will wear the HMS and the Holter monitor at the same time to record ECG signals.
        Researchers will evaluate the ECG recordings acquired from both devices and assess the above
        questions.
  observational model: Cohort
  time perspective: Prospective
  measure: Cardiac beat detection agreement
  time frame: 2 days
  description: The level of agreement between using the HMS and the Holter monitor (reference standard) ECG recordings in detection of beats
  measure: ECG characteristics measurement agreement
  time frame: 2 days
  description: The agreement (as evidenced by establishment of a positive linear relationship) of Holter monitor(reference standard) and HMS to measure each of the eight (8) ECG Characteristics. ECG characteristics measured in this study include: RR Interval (ms), PR Interval (ms), PP Interval (ms), QRS Duration (ms), QRS Amplitude (mV), P Wave Duration (ms), P Wave Amplitude (mV), and QT Interval (ms).
  measure: Cardiac rhythm outcome agreement
  time frame: 2 days
  description: The agreement of using Holter monitor (reference standard) and HMS ECG recordings to detect cardiac rhythms or rhythm disturbances.
  measure: Cardiac beat detection accuracy
  time frame: 2 days
  description: The Sensitivity and Positive Predictive Value (PPV) of using the HMS ECG recordings to detect cardiac beats.
  measure: Cardiac rhythm identification accuracy
  time frame: 2 days
  description: The Sensitivity and PPV of using the HMS ECG recordings to identify cardiac rhythm/rhythm disturbance.
  arm group label: Arrhythmia Participant
  description: Non-critical adult (21 years and older) participants that are suspected of having an arrhythmia or have evidence of arrhythmia requiring monitoring via 24-hour Holter monitor.
  intervention type: Device
  intervention name: Hexoskin Medical System
  description: Participant wears both the Hexoskin Medical System and the Nasiff Holter Monitor at the same time to acquire ECG recordings.
  arm group label: Arrhythmia Participant
  other name: Nasiff Holter Monitor
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Yutian Shu, Ph.D.
  phone: 888-887-2044
  email: yutian.shu@carretechnologies.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Arrhythmias, Cardiac
  sharing ipd: No
  ipd description: There is no plan to make IPD available.