<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/NCT03826225</url>
  </required_header>
  <id_info>
    <org_study_id>CARMEL</org_study_id>
    <nct_id>NCT03826225</nct_id>
  </id_info>
  <brief_title>Cardiac Monitor Employee Study</brief_title>
  <acronym>CARMEL</acronym>
  <official_title>Cardiac Monitor Employee Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This purpose of this study is to collect ECG data from a wearable cardiac monitor in order to&#xD;
      evaluate end-to-end performance of a cardiac monitor system and associated data management&#xD;
      accessories.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to evaluate the usability of the Wearable Cardiac Monitor&#xD;
      (WCM) system including the WCM, Mobile Monitors (patient and clinician), Magnet and LATITUDE&#xD;
      Clarity(TM) Server. The study will exercise the end-to-end system utilizing human ECG data&#xD;
      generated by the wearable cardiac monitor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 7, 2019</start_date>
  <completion_date type="Actual">May 23, 2019</completion_date>
  <primary_completion_date type="Actual">May 23, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate WCM System End-To-End Performance</measure>
    <time_frame>3 months</time_frame>
    <description>Characterize rate of success of wireless data transmissions from wearable cardiac monitor to LATITUDE Clarity(TM) server</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Arrhythmias, Cardiac</condition>
  <arm_group>
    <arm_group_label>Study Cohort</arm_group_label>
    <description>All participants are considered to be in the study cohort and will have the study device placed externally on their skin in order to collect human ECG data.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        This study will enroll volunteer adult participants who are employees of the study sponsor&#xD;
        and who meet all eligibility criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and capable to provide informed consent&#xD;
&#xD;
          -  Age 18 or above&#xD;
&#xD;
          -  Employee of the study sponsor&#xD;
&#xD;
          -  Willing and able to follow protocol requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently enrolled in another clinical study that interferes with data collection&#xD;
&#xD;
          -  Currently implanted with an active medical electronic device&#xD;
&#xD;
          -  Known allergies to the materials that may come in contact with the skin&#xD;
&#xD;
          -  Any active skin condition on the chest reported by the subject&#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>Dave Perschbacher</last_name>
    <role>Principal Investigator</role>
    <affiliation>Senior R&amp;D Fellow</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Scientific</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>July 3, 2019</last_update_submitted>
  <last_update_submitted_qc>July 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2019</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/NCT03826225
org study id: CARMEL
nct id: NCT03826225
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This purpose of this study is to collect ECG data from a wearable cardiac monitor in order to
      evaluate end-to-end performance of a cardiac monitor system and associated data management
      accessories.
The objective of this study is to evaluate the usability of the Wearable Cardiac Monitor
      (WCM) system including the WCM, Mobile Monitors (patient and clinician), Magnet and LATITUDE
      Clarity(TM) Server. The study will exercise the end-to-end system utilizing human ECG data
      generated by the wearable cardiac monitor.
observational model: Other
time perspective: Prospective
measure: Evaluate WCM System End-To-End Performance
time frame: 3 months
description: Characterize rate of success of wireless data transmissions from wearable cardiac monitor to LATITUDE Clarity(TM) server
arm group label: Study Cohort
description: All participants are considered to be in the study cohort and will have the study device placed externally on their skin in order to collect human ECG data.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dave Perschbacher
role: Principal Investigator
affiliation: Senior R&D Fellow
facility: 
country: United States
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac
sharing ipd: No