<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/NCT04435262</url>
  </required_header>
  <id_info>
    <org_study_id>181060320</org_study_id>
    <nct_id>NCT04435262</nct_id>
  </id_info>
  <brief_title>Syncope and Implanted Loop Recorder: the Utility of Remote Monitoring and Patients Centered Setting Alarms</brief_title>
  <official_title>Syncope and Implanted Loop Recorder: the Utility of Remote Monitoring and Patients Centered Setting Alarms in Real World Setting.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Campania &quot;Luigi Vanvitelli&quot;</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Campania &quot;Luigi Vanvitelli&quot;</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Actually, there are few data about the effectiveness of remote monitoring (RM) and patient&#xD;
      centered alarms setting in patients with unexplained syncope underwent implanted loop&#xD;
      recorder (ILR) monitoring.&#xD;
&#xD;
      The aim of this study is to evaluate the time from onset of first physician's evaluation of&#xD;
      asyntomatic ECG events lead to medical treatment in ordinary clinical practice for syncope&#xD;
      patients with ILR patients and compare it between patients followed with RM or conventionally&#xD;
      with annual in-hospital visits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 10, 2020</start_date>
  <completion_date type="Anticipated">March 16, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 16, 2022</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>Time to medical treatment</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Time from onset of first physician's evaluation of asyntomatic ECG events lead to medical treatment in ordinary clinical practice for syncope patients with ILR patients and compare it between patients followed with RM or conventionally with annual in-hospital visits.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Syncope</condition>
  <condition>Loop Recorder</condition>
  <condition>Remote Monitoring</condition>
  <arm_group>
    <arm_group_label>ILR Group followed with RM</arm_group_label>
    <description>Patients with unexplained syncope underwent ILR monitoring and followed with RM</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ILR Group followed with in-hospital visits</arm_group_label>
    <description>Patients with unexplained syncope underwent ILR monitoring and followed with in-hospital visits</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Remote Monitoring</intervention_name>
    <description>Remote Monitoring Follow-up</description>
    <arm_group_label>ILR Group followed with RM</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population included all patients with unexplained syncope underwent ICM&#xD;
        implantation according to current gudelines and followed by conventionally or RM according&#xD;
        to the hospital's clinical practice.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Patients with unexplained syncope underwent ICM implantation according to current&#xD;
             gudelines.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Patients do not provied signing Patient Informed Consent Form&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Vincenzo Russo, MD PhD</last_name>
    <phone>0817062355</phone>
    <email>vincenzo.russo@unicampania.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Vincenzo Russo</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Campania &quot;Luigi Vanvitelli&quot;</name>
      <address>
        <city>Naples</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vincenzo Russo</last_name>
      <email>vincenzo.russo@unicampania.it</email>
    </contact>
    <contact_backup>
      <last_name>Vincenzo Russo</last_name>
    </contact_backup>
    <investigator>
      <last_name>Vincenzo Russo, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>August 16, 2021</last_update_submitted>
  <last_update_submitted_qc>August 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Campania &quot;Luigi Vanvitelli&quot;</investigator_affiliation>
    <investigator_full_name>Vincenzo Russo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Syncope</keyword>
  <keyword>Loop Recorder</keyword>
  <keyword>Remote Monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syncope</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/NCT04435262
org study id: 181060320
nct id: NCT04435262
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Actually, there are few data about the effectiveness of remote monitoring (RM) and patient
      centered alarms setting in patients with unexplained syncope underwent implanted loop
      recorder (ILR) monitoring.

      The aim of this study is to evaluate the time from onset of first physician's evaluation of
      asyntomatic ECG events lead to medical treatment in ordinary clinical practice for syncope
      patients with ILR patients and compare it between patients followed with RM or conventionally
      with annual in-hospital visits.
observational model: Cohort
time perspective: Prospective
measure: Time to medical treatment
time frame: through study completion, an average of 1 year
description: Time from onset of first physician's evaluation of asyntomatic ECG events lead to medical treatment in ordinary clinical practice for syncope patients with ILR patients and compare it between patients followed with RM or conventionally with annual in-hospital visits.
arm group label: ILR Group followed with RM
description: Patients with unexplained syncope underwent ILR monitoring and followed with RM
arm group label: ILR Group followed with in-hospital visits
description: Patients with unexplained syncope underwent ILR monitoring and followed with in-hospital visits
intervention type: Other
intervention name: Remote Monitoring
description: Remote Monitoring Follow-up
arm group label: ILR Group followed with RM
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: N/A
last name: Vincenzo Russo, MD PhD
phone: 0817062355
email: vincenzo.russo@unicampania.it
last name: Vincenzo Russo
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Campania "Luigi Vanvitelli"
investigator full name: Vincenzo Russo
investigator title: Principal Investigator
mesh term: Syncope
sharing ipd: Undecided