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/NCT05983484</url>
    </required_header>
    <id_info>
      <org_study_id>MYANT/PACE - 073-1819-7</org_study_id>
      <nct_id>NCT05983484</nct_id>
    </id_info>
    <brief_title>Holter Versus Skiin Garments</brief_title>
    <official_title>Non-Invasive Monitoring of Arrhythmias Electrocardiogram (ECG) Using Textile Sensors (MYANT)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Myant Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Partners in Advanced Cardiac Evaluation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Myant 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 compare the electrocardiogram recording from&#xD;
        Holter monitor with textile sensors (in the form of clothing) in patients diagnosed with&#xD;
        arrhythmia. The study aims to answer the following questions:&#xD;
  &#xD;
          -  Can the textile sensors provide continuous monitoring and detect arrhythmias?&#xD;
  &#xD;
          -  Do patients prefer to wear textile sensors instead of the Holter?&#xD;
  &#xD;
        Participants that need Holter monitoring as part of their standard care will be invited to&#xD;
        participate in the study. They will simultaneously wear both, the Holter monitor and the&#xD;
        textile sensors for the time prescribed by their physician. Participants will also be asked&#xD;
        to answer a questionnaire in the initial assessment and at the end of the study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">December 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>Difference in Usable ECG</measure>
      <time_frame>Throughout the entire data collection period, that is between 1 and 14 days</time_frame>
      <description>The duration of diagnostic ECG from PocketECG minus the duration of diagnostic ECG from Skiin underwear</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Difference in Heart Rate</measure>
      <time_frame>Throughout the entire data collection period, that is between 1 and 14 days</time_frame>
      <description>The heart rate obtained from PocketECG minus the heart rate obtained from Skiin underwear</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Difference in RR intervals</measure>
      <time_frame>Throughout the entire data collection period, that is between 1 and 14 days</time_frame>
      <description>The RR intervals obtained from PocketECG minus the RR intervals obtained from Skiin underwear</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Arrhythmic events</measure>
      <time_frame>Throughout the entire data collection period, that is between 1 and 14 days</time_frame>
      <description>The number and proportion of arrhythmic events obtained by PocketECG and by Skiin underwear</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient's perception</measure>
      <time_frame>At the end of the study, 1 to 14 days after initiation.</time_frame>
      <description>A questionnaire developed by Myant containing 10 questions related to the comfort, usability, ease of use and enjoyment will be applied to assess patients' perception of the Skiin underwear and of the PocketECG and to compare both systems, with answers on a 7 point Lickert Scale (from Strongly disagree to Strongly Agree, no numeric scoring).</description>
    </secondary_outcome>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Cardiac Arrhythmia</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Skiin Underwear</intervention_name>
      <description>All participants enrolled will wear simultaneously the PocketECG (Standard Holter) and the Skiin Underwear Chestband (wearable textile). Each participant will wear both systems for the duration prescribed by their physician (1 to 14 days).</description>
      <other_name>PocketECG</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          adults with cardiovascular disease and/or risks justifying the need for performing an ECG&#xD;
          Holter&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being addressed to the PACE cardiology clinic to perform an ECG due to a diagnosed or&#xD;
               suspected cardiovascular disease.&#xD;
  &#xD;
            -  Age above 18&#xD;
  &#xD;
            -  Understand and speak English enough to consent and answer the study questionnaire.&#xD;
  &#xD;
            -  A medical need for Holter monitoring, and having a personal smartphone (iOS or&#xD;
               Android), compatible with the Skiin app (application used to monitor the patient using&#xD;
               the wearable device)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Implanted defibrillator or pacemaker&#xD;
  &#xD;
            -  Absence of garment fitting the participant's body&#xD;
  &#xD;
            -  Open wound or dressing (e.g. band-aid) on a body part that needs to be in contact with&#xD;
               the Skiin electrodes&#xD;
  &#xD;
            -  Severe frailty such that donning or doffing the garment may cause a danger of fall.&#xD;
  &#xD;
            -  Sensitive skin&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yaariv Khaykin, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Partners in Advanced Cardiac Evaluation</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yaariv Khaykin, MD</last_name>
      <phone>905 953 7917</phone>
      <email>ykhaykin@pace-cardiology.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jenny Gao-Kang</last_name>
      <email>JGaoKang@southlakeregional.org</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>ECG</keyword>
    <keyword>Wearable</keyword>
    <keyword>Holter</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>Undecided</sharing_ipd>
    </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/NCT05983484
  org study id: MYANT/PACE - 073-1819-7
  nct id: NCT05983484
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to compare the electrocardiogram recording from
        Holter monitor with textile sensors (in the form of clothing) in patients diagnosed with
        arrhythmia. The study aims to answer the following questions:
  
          -  Can the textile sensors provide continuous monitoring and detect arrhythmias?
  
          -  Do patients prefer to wear textile sensors instead of the Holter?
  
        Participants that need Holter monitoring as part of their standard care will be invited to
        participate in the study. They will simultaneously wear both, the Holter monitor and the
        textile sensors for the time prescribed by their physician. Participants will also be asked
        to answer a questionnaire in the initial assessment and at the end of the study.
  observational model: Cohort
  time perspective: Prospective
  measure: Difference in Usable ECG
  time frame: Throughout the entire data collection period, that is between 1 and 14 days
  description: The duration of diagnostic ECG from PocketECG minus the duration of diagnostic ECG from Skiin underwear
  measure: Difference in Heart Rate
  time frame: Throughout the entire data collection period, that is between 1 and 14 days
  description: The heart rate obtained from PocketECG minus the heart rate obtained from Skiin underwear
  measure: Difference in RR intervals
  time frame: Throughout the entire data collection period, that is between 1 and 14 days
  description: The RR intervals obtained from PocketECG minus the RR intervals obtained from Skiin underwear
  measure: Arrhythmic events
  time frame: Throughout the entire data collection period, that is between 1 and 14 days
  description: The number and proportion of arrhythmic events obtained by PocketECG and by Skiin underwear
  measure: Patient's perception
  time frame: At the end of the study, 1 to 14 days after initiation.
  description: A questionnaire developed by Myant containing 10 questions related to the comfort, usability, ease of use and enjoyment will be applied to assess patients' perception of the Skiin underwear and of the PocketECG and to compare both systems, with answers on a 7 point Lickert Scale (from Strongly disagree to Strongly Agree, no numeric scoring).
  intervention type: Device
  intervention name: Skiin Underwear
  description: All participants enrolled will wear simultaneously the PocketECG (Standard Holter) and the Skiin Underwear Chestband (wearable textile). Each participant will wear both systems for the duration prescribed by their physician (1 to 14 days).
  other name: PocketECG
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yaariv Khaykin, MD
  role: Principal Investigator
  affiliation: Partners in Advanced Cardiac Evaluation
  last name: Yaariv Khaykin, MD
  phone: 905 953 7917
  email: ykhaykin@pace-cardiology.com
  last name: Jenny Gao-Kang
  email: JGaoKang@southlakeregional.org
  responsible party type: Sponsor
  mesh term: Arrhythmias, Cardiac
  sharing ipd: Undecided