<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/NCT03012490</url>
  </required_header>
  <id_info>
    <org_study_id>2016_03</org_study_id>
    <secondary_id>2016-A00873-48</secondary_id>
    <nct_id>NCT03012490</nct_id>
  </id_info>
  <brief_title>Efficacy, Safety and Cost of Remote Monitoring of Patients With Cardiac Resynchronization Therapy</brief_title>
  <acronym>ECOST-CRT</acronym>
  <official_title>Efficacy, Safety and Cost of Comprehensive Versus Standard Remote Monitoring of Patients With Cardiac Resynchronization Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biotronik France</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>Yes</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 primary objective is to determine whether comprehensive remote follow-up in HF patients&#xD;
      with CRT will reduce the combined endpoint of all-cause mortality or worsening heart failure&#xD;
      hospitalizations, whichever comes first, when compared to basic remote monitoring, over a&#xD;
      27-month follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 27, 2017</start_date>
  <completion_date type="Actual">June 9, 2020</completion_date>
  <primary_completion_date type="Actual">June 9, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>composite criteria including death from any cause and hospitalization for worsening HF</measure>
    <time_frame>during the 27 months follow-up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Costs including hospital costs for unplanned cardiovascular hospitalizations, medical charges for ambulatory follow-up of CRT devices and transportation related costs</measure>
    <time_frame>27 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">652</enrollment>
  <condition>Heart Failure</condition>
  <condition>Cardiac Resynchronization Therapy</condition>
  <arm_group>
    <arm_group_label>Standard remote monitoring</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Remote monitoring of CRT-P and CRT-D is activated. The physician will only receive the notifications related to technical events and ventricular arrhythmias. Therapy will be added or changed in response to these notifications and/or the symptoms and signs observed during ambulatory visits.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comprehensive remote monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Remote monitoring of CRT-P and CRT-D is activated, as well as remote assessment of symptoms and signs. In addition to notifications related to technical events and ventricular arrhythmias, the physician will receive notifications related to heart failure parameters, atrial arrhythmias, and patient's symptoms and signs. Therapy will be added or changed in response to these notifications, and/or to the symptoms and signs observed during ambulatory visits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CRT-P or CRT-D standard remote monitoring</intervention_name>
    <description>standard for the control group: remote monitoring of ventricular rhythm disorders and technical parameters of the implanted system</description>
    <arm_group_label>Comprehensive remote monitoring</arm_group_label>
    <arm_group_label>Standard remote monitoring</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CRT-P or CRT-D full remote monitoring</intervention_name>
    <description>Full follow-up for the Active group: remote monitoring of ventricular rhythm disorders and technical parameters of the implanted system + supraventricular rhythm disorders, parameters related to heart failure, including symptoms and clinical signs of the patient</description>
    <arm_group_label>Comprehensive remote monitoring</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Symptoms and signs remote monitoring</intervention_name>
    <description>symptoms and clinical signs of the patient</description>
    <arm_group_label>Comprehensive remote monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient more than 18 years old, newly implanted, in accordance to the latest European&#xD;
             guidelines, with a CRT-P or CRT-D device (upgrading is tolerated but no device&#xD;
             replacement), with Home-Monitoring® activated&#xD;
&#xD;
          -  Patient willing and able to comply with the protocol and who has provided written&#xD;
             informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lead model under advisory&#xD;
&#xD;
          -  Non-functional lead except particular case of non-functional or deactivated right&#xD;
             atrial lead due to atrial fibrillation&#xD;
&#xD;
          -  Known drug or alcohol abuse&#xD;
&#xD;
          -  Pregnant woman or woman who plan to become pregnant during the trial (the data will be&#xD;
             collected by querying the patient without a pregnancy test is required)&#xD;
&#xD;
          -  Participation (ongoing or planned during the trial) in another interventional clinical&#xD;
             study, and/or another remote monitoring and/or follow-up concept, unless authorized by&#xD;
             the Executive Committee&#xD;
&#xD;
          -  Participation (ongoing or planned during the trial) in an investigational HF program&#xD;
             (e.g. PRADO, PIMPS, OSICAT, CARDIAUVERGNE)&#xD;
&#xD;
          -  Estimated life-expectancy, regardless of the cardiovascular condition, &lt;1year&#xD;
&#xD;
          -  Patient under- or planned for - ventricular assistance&#xD;
&#xD;
          -  Patient not living in Metropolitan France and/or not geographically stable&#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>Laurence Guedon-Moreau, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut coeur poumon, CHRU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>October 14, 2022</last_update_submitted>
  <last_update_submitted_qc>October 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Remote monitoring</keyword>
  <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>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/NCT03012490
org study id: 2016_03
secondary id: 2016-A00873-48
nct id: NCT03012490
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary objective is to determine whether comprehensive remote follow-up in HF patients
      with CRT will reduce the combined endpoint of all-cause mortality or worsening heart failure
      hospitalizations, whichever comes first, when compared to basic remote monitoring, over a
      27-month follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: composite criteria including death from any cause and hospitalization for worsening HF
time frame: during the 27 months follow-up
measure: Costs including hospital costs for unplanned cardiovascular hospitalizations, medical charges for ambulatory follow-up of CRT devices and transportation related costs
time frame: 27 months
arm group label: Standard remote monitoring
arm group type: Active Comparator
description: Remote monitoring of CRT-P and CRT-D is activated. The physician will only receive the notifications related to technical events and ventricular arrhythmias. Therapy will be added or changed in response to these notifications and/or the symptoms and signs observed during ambulatory visits.
arm group label: Comprehensive remote monitoring
arm group type: Experimental
description: Remote monitoring of CRT-P and CRT-D is activated, as well as remote assessment of symptoms and signs. In addition to notifications related to technical events and ventricular arrhythmias, the physician will receive notifications related to heart failure parameters, atrial arrhythmias, and patient's symptoms and signs. Therapy will be added or changed in response to these notifications, and/or to the symptoms and signs observed during ambulatory visits.
intervention type: Other
intervention name: CRT-P or CRT-D standard remote monitoring
description: standard for the control group: remote monitoring of ventricular rhythm disorders and technical parameters of the implanted system
arm group label: Comprehensive remote monitoring
arm group label: Standard remote monitoring
intervention type: Other
intervention name: CRT-P or CRT-D full remote monitoring
description: Full follow-up for the Active group: remote monitoring of ventricular rhythm disorders and technical parameters of the implanted system + supraventricular rhythm disorders, parameters related to heart failure, including symptoms and clinical signs of the patient
arm group label: Comprehensive remote monitoring
intervention type: Other
intervention name: Symptoms and signs remote monitoring
description: symptoms and clinical signs of the patient
arm group label: Comprehensive remote monitoring
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Laurence Guedon-Moreau, MD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No