<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/NCT03837574</url>
  </required_header>
  <id_info>
    <org_study_id>CNIL2029070</org_study_id>
    <nct_id>NCT03837574</nct_id>
  </id_info>
  <brief_title>French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator</brief_title>
  <acronym>DAI-T4F</acronym>
  <official_title>French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Paris Sudden Death Expertise Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Paris Sudden Death Expertise Center</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>
      National french registry of patients with tetralogy of Fallot and implantable cardioverter&#xD;
      defibrillator.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inclusion criteria:&#xD;
&#xD;
        -  patient with tetralogy of Fallot &gt; 18 years&#xD;
&#xD;
        -  implantable cardioverter defibrillator (ICD)&#xD;
&#xD;
        -  primary or secondary prevention&#xD;
&#xD;
      All french centers performing ICD implantation are annually contacted to include all patients&#xD;
      with tetralogy of Fallot and ICD.&#xD;
&#xD;
      Retrospective inclusion of cases before 2010 and prospective inclusion after 2010 with&#xD;
      prospective follow up and annual update.&#xD;
&#xD;
      All events are centrally adjudicated with collection of all baseline ECG and reviewing of&#xD;
      endocavitary EGM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2010</start_date>
  <completion_date type="Anticipated">December 31, 2030</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>20 Years</target_duration>
  <primary_outcome>
    <measure>Ventricular arrhythmias</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Rate of appropriate ICD therapies for ventricular tachycardia and fast ventricular tachycardia / ventricular fibrillation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complications of ICD</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Rate of complications of ICD including inappropriate therapies, infection, lead or generator dysfunction</description>
  </primary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Tetralogy of Fallot</condition>
  <condition>Implantable Defibrillator User</condition>
  <condition>Congenital Heart Disease</condition>
  <condition>Sudden Cardiac Death</condition>
  <condition>Ventricular Arrythmia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients with tetralogy of Fallot and implantablle cardioverter defibrillator in&#xD;
        France&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  tetralogy of Fallot&#xD;
&#xD;
          -  implantable cardioverter defibrillator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 years&#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>Victor Waldmann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Paris Sudden Death Expertise Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Victor Waldmann, MD</last_name>
    <phone>+33676098007</phone>
    <email>vicrtor.waldmann@inserm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Paris Sudden Death Expertise Center</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Victor Waldmann</last_name>
      <phone>+33676098007</phone>
      <email>victor.waldmann@inserm.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>February 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 9, 2019</last_update_submitted>
  <last_update_submitted_qc>February 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Paris Sudden Death Expertise Center</investigator_affiliation>
    <investigator_full_name>Marijon</investigator_full_name>
    <investigator_title>Principal Investigator Dr Victor WALDMANN</investigator_title>
  </responsible_party>
  <keyword>tretalogy of fallot</keyword>
  <keyword>implantable cardioverter defibrillator</keyword>
  <keyword>congenital heart disease</keyword>
  <keyword>sudden cardiac death</keyword>
  <keyword>ventricular arrhythmia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
    <mesh_term>Heart Defects, Congenital</mesh_term>
    <mesh_term>Death, Sudden, Cardiac</mesh_term>
    <mesh_term>Tetralogy of Fallot</mesh_term>
    <mesh_term>Death</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/NCT03837574
org study id: CNIL2029070
nct id: NCT03837574
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
National french registry of patients with tetralogy of Fallot and implantable cardioverter
      defibrillator.
Inclusion criteria:

        -  patient with tetralogy of Fallot > 18 years

        -  implantable cardioverter defibrillator (ICD)

        -  primary or secondary prevention

      All french centers performing ICD implantation are annually contacted to include all patients
      with tetralogy of Fallot and ICD.

      Retrospective inclusion of cases before 2010 and prospective inclusion after 2010 with
      prospective follow up and annual update.

      All events are centrally adjudicated with collection of all baseline ECG and reviewing of
      endocavitary EGM.
observational model: Cohort
time perspective: Prospective
measure: Ventricular arrhythmias
time frame: through study completion, an average of 1 year
description: Rate of appropriate ICD therapies for ventricular tachycardia and fast ventricular tachycardia / ventricular fibrillation
measure: Complications of ICD
time frame: through study completion, an average of 1 year
description: Rate of complications of ICD including inappropriate therapies, infection, lead or generator dysfunction
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Victor Waldmann, MD
role: Principal Investigator
affiliation: Paris Sudden Death Expertise Center
last name: Victor Waldmann, MD
phone: +33676098007
email: vicrtor.waldmann@inserm.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Paris Sudden Death Expertise Center
investigator full name: Marijon
investigator title: Principal Investigator Dr Victor WALDMANN
mesh term: Heart Diseases
mesh term: Arrhythmias, Cardiac
mesh term: Heart Defects, Congenital
mesh term: Death, Sudden, Cardiac
mesh term: Tetralogy of Fallot
mesh term: Death
sharing ipd: No