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/NCT05971225</url>
    </required_header>
    <id_info>
      <org_study_id>RemoteVerify</org_study_id>
      <nct_id>NCT05971225</nct_id>
    </id_info>
    <brief_title>Verifying Remote Monitoring Effect on Net Cardiovascular Outcome; RemoteVerify (RêVe)</brief_title>
    <acronym>ReVe</acronym>
    <official_title>Prospective Multicenter Observation Study on the Association Between Remote Monitoring and Clinical Outcome in Heart Failure Patients (Verifying Remote Monitoring Effect on Net Cardiovascular Outcome; RemoteVerify (RêVe))</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Saint Vincent's Hospital, Korea</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Biotronik SE &amp; Co. KG</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Saint Vincent's Hospital, Korea</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>
        This study investigates the impact and safety of wireless monitoring on the prognosis of&#xD;
        heart failure patients with implanted pacemakers and defibrillators. It aims to examine the&#xD;
        frequency of unplanned early hospital visits and the early diagnosis/intervention of disease&#xD;
        exacerbation based on the presence or absence of wireless monitoring. Additionally, the study&#xD;
        analyzes the influence of wireless monitoring on the patient's disease progression as well as&#xD;
        satisfaction of the study participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>one group with experience of in-office device monitoring &gt;6 months the other group without experience of in-office device monitoring</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Unplanned early visits for cardiac causes1 (Patient)</measure>
      <time_frame>6 months</time_frame>
      <description>i. Unplanned hospitalization/admission due to patient's condition changes -&gt; Patients' needs-driven early visits</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Unplanned early visits for cardiac causes2 (Patient)</measure>
      <time_frame>12months</time_frame>
      <description>i. Unplanned hospitalization/admission due to patient's condition changes -&gt; Patients' needs-driven early visits</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Unplanned early visits for cardiac causes3 (Patient)</measure>
      <time_frame>18months</time_frame>
      <description>i. Unplanned hospitalization/admission due to patient's condition changes -&gt; Patients' needs-driven early visits</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Unplanned early visits for cardiac causes4 (Patient)</measure>
      <time_frame>24months</time_frame>
      <description>i. Unplanned hospitalization/admission due to patient's condition changes -&gt; Patients' needs-driven early visits</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Unplanned early visits for cardiac causes1 (Clinic)</measure>
      <time_frame>6months</time_frame>
      <description>ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -&gt; Clinician-driven early visits</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Unplanned early visits for cardiac causes2 (Clinic)</measure>
      <time_frame>12months</time_frame>
      <description>ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -&gt; Clinician-driven early visits</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Unplanned early visits for cardiac causes3 (Clinic)</measure>
      <time_frame>18months</time_frame>
      <description>ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -&gt; Clinician-driven early visits</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Unplanned early visits for cardiac causes4 (Clinic)</measure>
      <time_frame>24months</time_frame>
      <description>ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -&gt; Clinician-driven early visits</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Acute myocardial infarction (heart attack) or cerebrovascular events (stroke)</measure>
      <time_frame>6,12,18,24 months</time_frame>
      <description>ACS, CVA</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Thromboembolic events (such as pulmonary embolism)</measure>
      <time_frame>6,12,18,24 months</time_frame>
      <description>Systemic thromboembolic events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Worsening of heart failure leading to hospitalization</measure>
      <time_frame>6,12,18,24 months</time_frame>
      <description>HF related admission</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiac-related deaths</measure>
      <time_frame>6,12,18,24 months</time_frame>
      <description>Cardiac cause deaths</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall mortality</measure>
      <time_frame>6,12,18,24 months</time_frame>
      <description>overall deaths</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">450</enrollment>
    <condition>Congestive Heart Failure</condition>
    <condition>Defibrillators</condition>
    <condition>Cardiac Resynchronization Therapy</condition>
    <arm_group>
      <arm_group_label>Follow up group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>participants with experience of &gt;6 months in-office device interrogation, then started remote monitoring</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Remote group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>participants with newly implanted device with study agreement, and then started remote monitoring</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>remote monitoring only</intervention_name>
      <description>remote monitoring only can replace in-office device monitoring</description>
      <arm_group_label>Follow up group</arm_group_label>
      <arm_group_label>Remote group</arm_group_label>
      <other_name>in office monitoring</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  consented heart failure patients (LVEF&lt;=40%) with Biotronik wireless monitoring&#xD;
               capable ICD/CRTs aged &gt;20 years&#xD;
  &#xD;
            -  patients who are new to remote monitoring&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  For patients with a life expectancy of less than 6 months. If patient do not&#xD;
               understand the contents of wireless monitoring or it is difficult to fill out the&#xD;
               consent form due to cognitive decline.&#xD;
  &#xD;
          If wireless monitoring is performed with a patient enrolled in another clinical trial which&#xD;
          remote monitoring may affect the previous enrolled study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>remote monitoring</keyword>
    <keyword>congestive heart failure</keyword>
    <keyword>Defibrillators</keyword>
    <keyword>cardiac resynchronization therapy</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>
      <ipd_description>It will not be open because its sensitive data, however, if there's reasonable request, data can be acquired after de-identification of the participants.</ipd_description>
    </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/NCT05971225
  org study id: RemoteVerify
  nct id: NCT05971225
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study investigates the impact and safety of wireless monitoring on the prognosis of
        heart failure patients with implanted pacemakers and defibrillators. It aims to examine the
        frequency of unplanned early hospital visits and the early diagnosis/intervention of disease
        exacerbation based on the presence or absence of wireless monitoring. Additionally, the study
        analyzes the influence of wireless monitoring on the patient's disease progression as well as
        satisfaction of the study participants.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: one group with experience of in-office device monitoring >6 months the other group without experience of in-office device monitoring
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Unplanned early visits for cardiac causes1 (Patient)
  time frame: 6 months
  description: i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits
  measure: Unplanned early visits for cardiac causes2 (Patient)
  time frame: 12months
  description: i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits
  measure: Unplanned early visits for cardiac causes3 (Patient)
  time frame: 18months
  description: i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits
  measure: Unplanned early visits for cardiac causes4 (Patient)
  time frame: 24months
  description: i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits
  measure: Unplanned early visits for cardiac causes1 (Clinic)
  time frame: 6months
  description: ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits
  measure: Unplanned early visits for cardiac causes2 (Clinic)
  time frame: 12months
  description: ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits
  measure: Unplanned early visits for cardiac causes3 (Clinic)
  time frame: 18months
  description: ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits
  measure: Unplanned early visits for cardiac causes4 (Clinic)
  time frame: 24months
  description: ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits
  measure: Acute myocardial infarction (heart attack) or cerebrovascular events (stroke)
  time frame: 6,12,18,24 months
  description: ACS, CVA
  measure: Thromboembolic events (such as pulmonary embolism)
  time frame: 6,12,18,24 months
  description: Systemic thromboembolic events
  measure: Worsening of heart failure leading to hospitalization
  time frame: 6,12,18,24 months
  description: HF related admission
  measure: Cardiac-related deaths
  time frame: 6,12,18,24 months
  description: Cardiac cause deaths
  measure: Overall mortality
  time frame: 6,12,18,24 months
  description: overall deaths
  arm group label: Follow up group
  arm group type: Active Comparator
  description: participants with experience of >6 months in-office device interrogation, then started remote monitoring
  arm group label: Remote group
  arm group type: Experimental
  description: participants with newly implanted device with study agreement, and then started remote monitoring
  intervention type: Other
  intervention name: remote monitoring only
  description: remote monitoring only can replace in-office device monitoring
  arm group label: Follow up group
  arm group label: Remote group
  other name: in office monitoring
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Heart Failure
  sharing ipd: No
  ipd description: It will not be open because its sensitive data, however, if there's reasonable request, data can be acquired after de-identification of the participants.