<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/NCT03009175</url>
  </required_header>
  <id_info>
    <org_study_id>PRoMOTE FU</org_study_id>
    <nct_id>NCT03009175</nct_id>
  </id_info>
  <brief_title>PRoMOTE Follow-up Observational Study</brief_title>
  <acronym>PRoMOTE FU</acronym>
  <official_title>Patient Risk Triage in ICD Remote Follow-up Observational Study (PRoMOTE FU)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Bakken Research Center</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Bakken Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is:&#xD;
&#xD;
        -  To evaluate the Heart Failure Risk Status (HFRS) feature performance.&#xD;
&#xD;
        -  To establish the feasibility of remote follow-up in which patient risk triaging is&#xD;
           performed by nurse-led review of HFRS feature as supplemental information.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Data collected through the phone call to the patients during the 6 months of study duration will be correlated to the HF risk classification provided by the HFRS feature on each transmission.</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">287</enrollment>
  <condition>Heart Failure</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy Defibrillator/Pacemaker</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study population will include patients of both sexes included in the Medtronic CareLink®&#xD;
        Network and implanted with a Medtronic wireless implantable cardiac defibrillator (ICD) or&#xD;
        cardiac resynchronization therapy device with defibrillation capabilities device (CRT-D) at&#xD;
        Hospital Araba (former Hospital Txagorritxu). There are approximately 223 ICD and CRT-D&#xD;
        patients included in the CareLink® Network at this site, and average number of&#xD;
        transmissions per month is ~80, so it is expected that 480 transmissions are received&#xD;
        during the study duration.&#xD;
&#xD;
        From this population, less than 10% are implanted with a device without Optivol® feature.&#xD;
        For these patients we will not have HFRS data.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients that meet all of following criteria could be included in the study:&#xD;
&#xD;
          -  Implant of a commercially available Medtronic CRTD or ICD device with or without the&#xD;
             Optivol Fluid Status Monitoring feature.&#xD;
&#xD;
          -  Inclusion in the Medtronic Carelink Network.&#xD;
&#xD;
          -  Local consent available for CL network as well as general local consent available for&#xD;
             the use of data in observational studies signed and informative sheet delivered.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under the age of 18 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>January 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>December 30, 2016</last_update_submitted>
  <last_update_submitted_qc>December 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</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>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03009175
org study id: PRoMOTE FU
nct id: NCT03009175
lead sponsor: 
has dmc: No
The purpose of the study is:

        -  To evaluate the Heart Failure Risk Status (HFRS) feature performance.

        -  To establish the feasibility of remote follow-up in which patient risk triaging is
           performed by nurse-led review of HFRS feature as supplemental information.
time perspective: Prospective
measure: Clinical Data collected through the phone call to the patients during the 6 months of study duration will be correlated to the HF risk classification provided by the HFRS feature on each transmission.
time frame: 6 months
intervention type: Device
intervention name: Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy Defibrillator/Pacemaker
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: Undecided