<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/NCT04420078</url>
  </required_header>
  <id_info>
    <org_study_id>BRAVO Registry</org_study_id>
    <nct_id>NCT04420078</nct_id>
  </id_info>
  <brief_title>Brugada Ablation of VF Substrate Ongoing MultiCenter Registry</brief_title>
  <acronym>BRAVO</acronym>
  <official_title>Brugada Ablation of VF Substrate Ongoing MultiCenter Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pacific Rim Electrophysiology Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Tsukuba</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Amsterdam</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ogaki Municipal Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Taipei Veterans General Hospital, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pacific Rim Electrophysiology Research Institute</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>
      Current treatment of high-risk Brugada Syndrome (BrS) patients (pts) with recurrent VF is&#xD;
      limited. Catheter ablation (CA) has been performed for BrS but a large study with long-term&#xD;
      outcomes of CA in BrS ablation are lacking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Brugada syndrome (BrS) patients who undergo BRS substrate ablations from tertiary centers for&#xD;
      catheter ablations of complex arrhythmias from three continents - Asia, Europe and North&#xD;
      America - are registered in a common database. The investigators exclude patients who were&#xD;
      lost to follow up in the outpatient clinic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">May 1, 2022</completion_date>
  <primary_completion_date type="Actual">February 28, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Death</measure>
    <time_frame>3 years</time_frame>
    <description>Expiration, unrelated to procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ICD Therapy for VT/VF</measure>
    <time_frame>3 years</time_frame>
    <description>Electrical therapy delivered through device for termination of VF episodes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inappropriate ICD Therapy</measure>
    <time_frame>3 years</time_frame>
    <description>Caused by lead sensing or programming errors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Normalization of Brugada ECG pattern</measure>
    <time_frame>3 years</time_frame>
    <description>ECG pattern is normal sinus rhythm after catheter ablation</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">159</enrollment>
  <condition>Brugada Syndrome</condition>
  <arm_group>
    <arm_group_label>CA BrS</arm_group_label>
    <description>Symptomatic BrS patients who underwent catheter ablation of the BrS/VF substrate</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Catheter Ablation</intervention_name>
    <description>Ventricular fibrillation substrate</description>
    <arm_group_label>CA BrS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have positive Brugada ECG pattern and have underwent catheter ablation of VF&#xD;
        substrates prior to enrollment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptomatic Brugada Syndrome patients who had undergone catheter ablation of the&#xD;
             arrhythmogenic substrates.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who will not commit to regular follow up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pacific Rim Electrophysiology Research Institute, Chulalongkorn University</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>March 1, 2023</last_update_submitted>
  <last_update_submitted_qc>March 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
    <ipd_description>All data published will be deindentified</ipd_description>
  </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/NCT04420078
org study id: BRAVO Registry
nct id: NCT04420078
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Current treatment of high-risk Brugada Syndrome (BrS) patients (pts) with recurrent VF is
      limited. Catheter ablation (CA) has been performed for BrS but a large study with long-term
      outcomes of CA in BrS ablation are lacking.
Brugada syndrome (BrS) patients who undergo BRS substrate ablations from tertiary centers for
      catheter ablations of complex arrhythmias from three continents - Asia, Europe and North
      America - are registered in a common database. The investigators exclude patients who were
      lost to follow up in the outpatient clinic.
observational model: Cohort
time perspective: Retrospective
measure: Death
time frame: 3 years
description: Expiration, unrelated to procedure
measure: ICD Therapy for VT/VF
time frame: 3 years
description: Electrical therapy delivered through device for termination of VF episodes
measure: Inappropriate ICD Therapy
time frame: 3 years
description: Caused by lead sensing or programming errors
measure: Normalization of Brugada ECG pattern
time frame: 3 years
description: ECG pattern is normal sinus rhythm after catheter ablation
arm group label: CA BrS
description: Symptomatic BrS patients who underwent catheter ablation of the BrS/VF substrate
intervention type: Procedure
intervention name: Catheter Ablation
description: Ventricular fibrillation substrate
arm group label: CA BrS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Thailand
responsible party type: Sponsor
mesh term: Brugada Syndrome
sharing ipd: No
ipd description: All data published will be deindentified