<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/NCT03294278</url>
  </required_header>
  <id_info>
    <org_study_id>IRCCSDonato Brugada-randomized</org_study_id>
    <nct_id>NCT03294278</nct_id>
  </id_info>
  <brief_title>Epicardial Ablation in Brugada Syndrome to Prevent Sudden Death</brief_title>
  <official_title>Epicardial Ablation in Brugada Syndrome in the Prevention of Sudden Cardiac Death. A Randomized Prospective Follow-up Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Policlinico S. Donato</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Policlinico S. Donato</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>
      A total of 150 patients will be randomized to perform catheter ablation or not in a 2:1&#xD;
      fashion in selected patients with Brugada-related symptoms (Ablation+ICD arm 105 patients vs&#xD;
      ICD only 45 patients).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main purpose of this trial is to develop evidence-based curative treatment with optimal&#xD;
      net benefit for patients with Brugada syndrome. As recent non-randomized pilot studies and&#xD;
      scarce case reports documented the potential benefit of epicardial ablation, patients in this&#xD;
      trial will be randomized to epicardial catheter ablation of the regions exhibiting abnormally&#xD;
      prolonged and fragmented electrograms in the right ventricular outflow tract plus continued&#xD;
      implanted cardioverter defibrillator therapy (ablation arm) or continued implanted&#xD;
      cardioverter defibrillator therapy (control arm).&#xD;
&#xD;
      Survival from any ventricular arrhythmia (VA) recurrence will be considered as primary&#xD;
      endpoint.&#xD;
&#xD;
      A projected 150 patients will be enrolled and randomized to receive ablation or not in a 2:1&#xD;
      fashion (Ablation+ICD arm 105 patients vs ICD only 45 patients).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 10, 2017</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival from any VA recurrence will be considered as primary endpoint</measure>
    <time_frame>2 years after ablation</time_frame>
    <description>NO ventricular arrhythmia recurrence</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Ventricular Arrhythmias and Cardiac Arrest</condition>
  <arm_group>
    <arm_group_label>Ablation plus ICD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Epicardial ablation by radio-frequency</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ICD alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Implantation of ICD</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ablation plus ICD</intervention_name>
    <description>Defibrillator, radio-frequency catheter ablation</description>
    <arm_group_label>Ablation plus ICD</arm_group_label>
    <arm_group_label>ICD alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients affected by Brugada Syndrome diagnosed according to 2013 HRS/EHRA/APHRS&#xD;
&#xD;
          -  Consensus document criteria&#xD;
&#xD;
          -  The patient received at least 1 appropriate ICD shock.&#xD;
&#xD;
          -  Documentation of any previous ventricular arrhythmia (VA) in the form of VT,&#xD;
             non-sustained VT, non-sustained VF, RVOT PVC with a daily burden &gt;10000;&#xD;
&#xD;
          -  Age ≥ 18;&#xD;
&#xD;
          -  Willingness to attend follow-up examinations;&#xD;
&#xD;
          -  Written informed consent for participation in the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A patient who does not meet inclusion criteria;&#xD;
&#xD;
          -  Pregnancy or breast-feeding (which would exclude an ablation procedure);&#xD;
&#xD;
          -  Contraindications to general anesthesia or epicardial ablation;&#xD;
&#xD;
          -  Life expectancy &lt; 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlo Pappone, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Policlinico San Donato Milan, Italy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carlo Pappone, MD</last_name>
    <phone>+39 02 52774260</phone>
    <email>carlo.pappone@af-ablation.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>IRCCS Policlinico S. Donato</name>
      <address>
        <city>San Donato Milanese</city>
        <state>Milano</state>
        <zip>20097</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carlo Pappone, MD, PhD</last_name>
      <phone>00390252774260</phone>
      <email>carlo.pappone@af-ablation.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>May 16, 2021</last_update_submitted>
  <last_update_submitted_qc>May 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Policlinico S. Donato</investigator_affiliation>
    <investigator_full_name>Carlo Pappone</investigator_full_name>
    <investigator_title>Chief of Arrhythmology Department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brugada Syndrome</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/NCT03294278
org study id: IRCCSDonato Brugada-randomized
nct id: NCT03294278
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A total of 150 patients will be randomized to perform catheter ablation or not in a 2:1
      fashion in selected patients with Brugada-related symptoms (Ablation+ICD arm 105 patients vs
      ICD only 45 patients).
The main purpose of this trial is to develop evidence-based curative treatment with optimal
      net benefit for patients with Brugada syndrome. As recent non-randomized pilot studies and
      scarce case reports documented the potential benefit of epicardial ablation, patients in this
      trial will be randomized to epicardial catheter ablation of the regions exhibiting abnormally
      prolonged and fragmented electrograms in the right ventricular outflow tract plus continued
      implanted cardioverter defibrillator therapy (ablation arm) or continued implanted
      cardioverter defibrillator therapy (control arm).

      Survival from any ventricular arrhythmia (VA) recurrence will be considered as primary
      endpoint.

      A projected 150 patients will be enrolled and randomized to receive ablation or not in a 2:1
      fashion (Ablation+ICD arm 105 patients vs ICD only 45 patients).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Survival from any VA recurrence will be considered as primary endpoint
time frame: 2 years after ablation
description: NO ventricular arrhythmia recurrence
arm group label: Ablation plus ICD
arm group type: Active Comparator
description: Epicardial ablation by radio-frequency
arm group label: ICD alone
arm group type: Active Comparator
description: Implantation of ICD
intervention type: Other
intervention name: ablation plus ICD
description: Defibrillator, radio-frequency catheter ablation
arm group label: Ablation plus ICD
arm group label: ICD alone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Carlo Pappone, MD
role: Principal Investigator
affiliation: IRCCS Policlinico San Donato Milan, Italy
last name: Carlo Pappone, MD
phone: +39 02 52774260
email: carlo.pappone@af-ablation.org
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Policlinico S. Donato
investigator full name: Carlo Pappone
investigator title: Chief of Arrhythmology Department
mesh term: Brugada Syndrome
sharing ipd: No