<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/NCT01691573</url>
  </required_header>
  <id_info>
    <org_study_id>EU01</org_study_id>
    <nct_id>NCT01691573</nct_id>
  </id_info>
  <brief_title>European Pediatric Catheter Ablation Registry</brief_title>
  <acronym>EUROPA</acronym>
  <official_title>European Pediatric Catheter Ablation Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>A.O. Ospedale Papa Giovanni XXIII</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>A.O. Ospedale Papa Giovanni XXIII</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of the European Pediatric Catheter Ablation Registry is to collect data on&#xD;
      ablation procedures in the European pediatric population in order to improve the management&#xD;
      of this subset of patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Catheter ablation has revolutionized the management of cardiac arrhythmias in patients and&#xD;
      has become first-line therapy for managing many pediatric patients with atrioventricular&#xD;
      accessory pathway or atrioventricular nodal-mediated supraventricular tachycardia.&#xD;
&#xD;
      Cardiac ablation in children is not a standardized procedure as in adults as evidence gaps&#xD;
      still have to be filled. On a European perspective, lack of a dedicated scientific society&#xD;
      has limited so far the collection and sharing of data among the most experienced centers.&#xD;
&#xD;
      Actually there are no sufficient data available about the management of pediatric patients&#xD;
      undergoing ablation in clinical practice, in particular regarding indications, methodology&#xD;
      and clinical follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2012</start_date>
  <completion_date type="Anticipated">July 2016</completion_date>
  <primary_completion_date type="Anticipated">July 2016</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>To collect data on ablation procedures in the European pediatric population.</measure>
    <time_frame>After 12 months from the ablation procedure</time_frame>
    <description>Primary outcome will be a combination of efficacy (arrhythmia recurrency) and safety (procedural and late complications)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To describe and compare different ablation methodologies</measure>
    <time_frame>After 12 months from the ablation procedure</time_frame>
    <description>Rate of index arrhythmia recurrence and rate of complications will be compared for different ablation technology (electroanatomical mapping system vs standard mapping) and for different energy source(radiofrequency vs cryo)</description>
  </secondary_outcome>
  <condition>Cardiac Arrhythmias</condition>
  <eligibility>
    <study_pop>
      <textblock>
        European pediatric population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients scheduled to any kind of an ablation procedure;&#xD;
&#xD;
          -  Patient´s age between 0 and 18 years;&#xD;
&#xD;
          -  Legal guardians understand the nature of the procedure, are willing to comply with&#xD;
             study follow-up evaluations, and provide written informed consent prior to the&#xD;
             procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient unable to comply with follow-up schedule;&#xD;
&#xD;
          -  Patient has medical conditions that preclude protocol compliance or limit study&#xD;
             participation;&#xD;
&#xD;
          -  Legal guardian or patient unwilling or unable to provide informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francesco Cantù, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ospedale Manzoni, Via dell'Eremo 9/11 23900 Lecco, Italy.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Francesco Cantù, MD</last_name>
    <phone>0341 489 492</phone>
    <email>f.cantu@ospedale.lecco.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital Motol</name>
      <address>
        <city>Prague</city>
        <zip>150 00</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Jan Janousek, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Leipzig GmbH</name>
      <address>
        <city>Leipzig</city>
        <zip>04289</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Roman Gebauer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ospedali Riuniti di Bergamo</name>
      <address>
        <city>Bergamo</city>
        <state>BG</state>
        <zip>24128</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Paolo De Filippo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ospedali Manzoni</name>
      <address>
        <city>Lecco</city>
        <state>LE</state>
        <zip>23900</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Francesco Cantu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ospedale S. Raffaele</name>
      <address>
        <city>Milano</city>
        <state>MI</state>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Paolo Della Bella, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Leiden University Medical Center</name>
      <address>
        <city>Leiden</city>
        <zip>2300</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Nico Blom, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Czech Republic</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>September 24, 2012</last_update_submitted>
  <last_update_submitted_qc>September 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>A.O. Ospedale Papa Giovanni XXIII</investigator_affiliation>
    <investigator_full_name>Paolo De Filippo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>ablation</keyword>
  <keyword>procedure</keyword>
  <keyword>pediatric</keyword>
  <keyword>european</keyword>
  <keyword>cardiac</keyword>
  <keyword>arrhythmias</keyword>
  <keyword>registry</keyword>
  <keyword>observational</keyword>
  <keyword>prospective</keyword>
  <keyword>catheter</keyword>
  <keyword>cryoablation</keyword>
  <keyword>atrioventricular</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</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/NCT01691573
org study id: EU01
nct id: NCT01691573
lead sponsor: 
has dmc: No
The main objective of the European Pediatric Catheter Ablation Registry is to collect data on
      ablation procedures in the European pediatric population in order to improve the management
      of this subset of patients.
Catheter ablation has revolutionized the management of cardiac arrhythmias in patients and
      has become first-line therapy for managing many pediatric patients with atrioventricular
      accessory pathway or atrioventricular nodal-mediated supraventricular tachycardia.

      Cardiac ablation in children is not a standardized procedure as in adults as evidence gaps
      still have to be filled. On a European perspective, lack of a dedicated scientific society
      has limited so far the collection and sharing of data among the most experienced centers.

      Actually there are no sufficient data available about the management of pediatric patients
      undergoing ablation in clinical practice, in particular regarding indications, methodology
      and clinical follow-up.
observational model: Cohort
time perspective: Prospective
measure: To collect data on ablation procedures in the European pediatric population.
time frame: After 12 months from the ablation procedure
description: Primary outcome will be a combination of efficacy (arrhythmia recurrency) and safety (procedural and late complications)
measure: To describe and compare different ablation methodologies
time frame: After 12 months from the ablation procedure
description: Rate of index arrhythmia recurrence and rate of complications will be compared for different ablation technology (electroanatomical mapping system vs standard mapping) and for different energy source(radiofrequency vs cryo)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Francesco Cantù, MD
role: Principal Investigator
affiliation: Ospedale Manzoni, Via dell'Eremo 9/11 23900 Lecco, Italy.
last name: Francesco Cantù, MD
phone: 0341 489 492
email: f.cantu@ospedale.lecco.it
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
country: Czech Republic
country: Germany
country: Italy
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: A.O. Ospedale Papa Giovanni XXIII
investigator full name: Paolo De Filippo
investigator title: Principal Investigator
mesh term: Arrhythmias, Cardiac