<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/NCT02991716</url>
  </required_header>
  <id_info>
    <org_study_id>NPC02</org_study_id>
    <nct_id>NCT02991716</nct_id>
  </id_info>
  <brief_title>Surface Electrocardiogram (ECG) Signal Recording for Implantable Subcutaneous String Defibrillator (ISSD) Development</brief_title>
  <official_title>Surface Electrocardiogram (ECG) Signal Recording for Implantable Subcutaneous String Defibrillator (ISSD) Development</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NewPace Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NewPace Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Record cutaneous Electrocardiogram (ECG) data from positions corresponding to the expected&#xD;
      subcutaneous locations of the Implantable Subcutaneous String Defibrillator (ISSD) using&#xD;
      existing, approved ECG recording devices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      2 electrodes places near the sternum and 2 near the midaxillary line, simulating the expected&#xD;
      positions of Implantable Subcutaneous String Defibrillator (ISSD) sense electrodes. reference&#xD;
      ECG electrodes are also attached (in most cases). Approved ECG recording devices are used to&#xD;
      record the signal continuously: During an EP session (different types) a bedside recorder,&#xD;
      and a holter monitor is used during holter recordings. Ep session recordings are performed in&#xD;
      order to capture different types of arrhythmia, and holter recordings are performed to&#xD;
      observe changes in ECG morphology due to activity, position changes, circadian cycles etc.&#xD;
      The data is saved and used in the development of the ISSD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</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>successful recording of Electrocardiogram (ECG) from a patient containing arrhythmia</measure>
    <time_frame>immediate</time_frame>
    <description>recorded Electrocardiogram (ECG) of patients with as many arrhythmia events as possible, preferably tachy-arrhythmia events such as fast VT, flutter or VF</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Arrhythmia, Cardiac</condition>
  <arm_group>
    <arm_group_label>Recorded patients</arm_group_label>
    <description>Patients requiring Intracradiac Defibrillator (ICD) implantation, Electrophysiology (EP) study or a holter monitor recording, mainly due to suspected ventricular tachy - arrhythmias</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>recorded patients</intervention_name>
    <description>No intervention applied, only recording of cutaneous ECG signal from specific points on the torsi</description>
    <arm_group_label>Recorded patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients requiring Intracradiac Defibrillator (ICD) implantation, Electrophysiology (EP)&#xD;
        study or a holter monitor recording, mainly due to suspected ventricular tachy -&#xD;
        arrhythmias&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Candidate for ICD implantation&#xD;
&#xD;
          -  Candidate for EP study&#xD;
&#xD;
          -  Candidate for 24 hour holter monitor recording&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age&lt;18&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vladimir Rankovic, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>JFK Medical Center, Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>JFK Medical Center</name>
      <address>
        <city>Atlantis</city>
        <state>Florida</state>
        <zip>33462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>January 15, 2018</last_update_submitted>
  <last_update_submitted_qc>January 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2018</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>
  <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/NCT02991716
org study id: NPC02
nct id: NCT02991716
lead sponsor: 
has dmc: No
Record cutaneous Electrocardiogram (ECG) data from positions corresponding to the expected
      subcutaneous locations of the Implantable Subcutaneous String Defibrillator (ISSD) using
      existing, approved ECG recording devices.
2 electrodes places near the sternum and 2 near the midaxillary line, simulating the expected
      positions of Implantable Subcutaneous String Defibrillator (ISSD) sense electrodes. reference
      ECG electrodes are also attached (in most cases). Approved ECG recording devices are used to
      record the signal continuously: During an EP session (different types) a bedside recorder,
      and a holter monitor is used during holter recordings. Ep session recordings are performed in
      order to capture different types of arrhythmia, and holter recordings are performed to
      observe changes in ECG morphology due to activity, position changes, circadian cycles etc.
      The data is saved and used in the development of the ISSD.
observational model: Cohort
time perspective: Prospective
measure: successful recording of Electrocardiogram (ECG) from a patient containing arrhythmia
time frame: immediate
description: recorded Electrocardiogram (ECG) of patients with as many arrhythmia events as possible, preferably tachy-arrhythmia events such as fast VT, flutter or VF
arm group label: Recorded patients
description: Patients requiring Intracradiac Defibrillator (ICD) implantation, Electrophysiology (EP) study or a holter monitor recording, mainly due to suspected ventricular tachy - arrhythmias
intervention type: Other
intervention name: recorded patients
description: No intervention applied, only recording of cutaneous ECG signal from specific points on the torsi
arm group label: Recorded patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Vladimir Rankovic, M.D
role: Principal Investigator
affiliation: JFK Medical Center, Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac
sharing ipd: No