<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/NCT02253134</url>
  </required_header>
  <id_info>
    <org_study_id>SYNARR-FLASH STUDY - ITHO04</org_study_id>
    <nct_id>NCT02253134</nct_id>
  </id_info>
  <brief_title>Monitoring of Syncopes and/or Sustained Palpitations of Suspected Arrhythmic Origin With External Loop-Recorder (SpiderFLASH)</brief_title>
  <acronym>ITHO04</acronym>
  <official_title>Monitoring of Syncopes and/or Sustained Palpitations of Suspected Arrhythmic Origin With External Loop-Recorder (SpiderFLASH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LivaNova</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LivaNova</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the diagnostic yield (at 1 month post enrollment) of&#xD;
      an external loop recorder (SpiderFlash-T) in patients with syncope or palpitations of&#xD;
      suspected arrhythmic origin, within 30 days before enrollment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diagnostic yield (primary outcome) definition = Number of patients with conclusive diagnosis&#xD;
      (as per investigators' decision) over the total number of patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2010</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Evaluate the mean value of the diagnostic yield in one month</measure>
    <time_frame>1 month</time_frame>
    <description>number of pts with a conclusive diagnosis (per investigators' decision) over the total number of patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic yield of the ELR stratified by each kind of diagnosed event, by week and by event occurred post enrollment</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence rate stratified by syncope /palpitation, by week and by type of events occurred post enrollment</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of arrhythmic vs non arrhythmic findings stratified by kind of index events (syncope /palpitations)</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">395</enrollment>
  <condition>Syncope</condition>
  <condition>Palpitations</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients that present unexplained Syncope and/or palpitations events of a suspected&#xD;
        arrhythmic origin&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Syncope and/or palpitations events occurred in the last 30 days&#xD;
&#xD;
          -  Events likely of arrhythmic origin&#xD;
&#xD;
          -  No conclusive diagnosis established yet&#xD;
&#xD;
          -  High probability of episodes recurrence (presence of at least one previous event in&#xD;
             the last 12 months)&#xD;
&#xD;
          -  Patient has signed the consent to participate to the study and/or to data treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to understand the purpose of the study or refusal to cooperate&#xD;
&#xD;
          -  Expected low compliance with the recording technique.&#xD;
&#xD;
          -  Logistical impossibility to deliver the ELR within 30 days after the index event (or&#xD;
             after discharge from ER and/or hospitalization and/or clinic visit)&#xD;
&#xD;
          -  Already included in other competitor clinical study&#xD;
&#xD;
          -  Under guardianship&#xD;
&#xD;
          -  Age less than 18&#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>Emanuela T Locati</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliera Niguarda Ca' Granda - Milano</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Gasthuisberg Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az. Sanit. Locale N. 4 Chiavarese</name>
      <address>
        <city>Lavagna</city>
        <zip>16033</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Niguarda Ca Granda</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Santa Marta</name>
      <address>
        <city>Lisboa</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Universitari Dexeus</name>
      <address>
        <city>Barcelona</city>
        <zip>08028</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Bellvitge</name>
      <address>
        <city>Barcelona</city>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Basurto</name>
      <address>
        <city>Bilbao</city>
        <zip>48013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik für Kardiologie Inselspital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Italy</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>July 10, 2013</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>September 30, 2014</last_update_submitted>
  <last_update_submitted_qc>September 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Syncopal events</keyword>
  <keyword>Palpitation events</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syncope</mesh_term>
  </condition_browse>
  <!-- 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/NCT02253134
org study id: SYNARR-FLASH STUDY - ITHO04
nct id: NCT02253134
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the diagnostic yield (at 1 month post enrollment) of
      an external loop recorder (SpiderFlash-T) in patients with syncope or palpitations of
      suspected arrhythmic origin, within 30 days before enrollment.
Diagnostic yield (primary outcome) definition = Number of patients with conclusive diagnosis
      (as per investigators' decision) over the total number of patients
time perspective: Prospective
measure: Evaluate the mean value of the diagnostic yield in one month
time frame: 1 month
description: number of pts with a conclusive diagnosis (per investigators' decision) over the total number of patients
measure: Diagnostic yield of the ELR stratified by each kind of diagnosed event, by week and by event occurred post enrollment
time frame: 1 month
measure: Recurrence rate stratified by syncope /palpitation, by week and by type of events occurred post enrollment
time frame: 1 month
measure: Analysis of arrhythmic vs non arrhythmic findings stratified by kind of index events (syncope /palpitations)
time frame: 1 month
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emanuela T Locati
role: Principal Investigator
affiliation: Azienda Ospedaliera Niguarda Ca' Granda - Milano
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Italy
country: Portugal
country: Spain
country: Switzerland
responsible party type: Sponsor
mesh term: Syncope