<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/NCT03764592</url>
  </required_header>
  <id_info>
    <org_study_id>PACIFICReri2</org_study_id>
    <nct_id>NCT03764592</nct_id>
  </id_info>
  <brief_title>VF Mapping in Brugada and Early Repolarization Syndromes</brief_title>
  <official_title>Mapping of Ventricular Fibrillation (VF) Substrates and VF Arrhythmogenic Sources/Reentrant Circuits in Patients With Brugada and Early Repolarization Syndromes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pacific Rim Electrophysiology Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Bordeaux</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>
      To determine the values and limitations of ECGI in guiding ablation and risk stratification&#xD;
      in patients with BrS and Early Repolarization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will study symptomatic BrS and ERs syndrome (N=25) and asymptomatic&#xD;
      patients (N=25) age between 16-70 years old to determine values and limitations of&#xD;
      non-invasive mapping using electrocardiographic imaging (ECGI) in identifying VF substrates&#xD;
      as target sites for catheter ablations in patients with Brugada (BrS) and Early&#xD;
      repolarization syndromes (ERS) and also determine the mechanisms of VF in BrS and ERs&#xD;
      syndromes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 23, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2024</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>VF death</measure>
    <time_frame>3 years</time_frame>
    <description>ventricular fibrillation</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Brugada Syndrome</condition>
  <condition>Early Repolarization Syndrome</condition>
  <arm_group>
    <arm_group_label>VF BrS/ERS patients</arm_group_label>
    <description>Only patients that diagnosed with BrS or ERS based on ECG criteria</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>radiofrequency ablation</intervention_name>
    <description>Symptomatic patients whose substrates were identified will undergo catheter ablation; asymptomatic patients will be followed without undergoing catheter ablation.</description>
    <arm_group_label>VF BrS/ERS patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Brugada marker or early repolarization marker on ECG.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients presenting with the type1 BrS ECG or ER ECG signature pattern, with/without a&#xD;
        sodium channel blocker. Patients with the following one of these symptoms or arrhythmias&#xD;
        will be considered as symptomatic patients: 1) aborted cardiac arrest cases, 2) documented&#xD;
        VF episodes, 3) agonal respiration during sleep with difficulty to arouse, 4) syncope of&#xD;
        unknown origin, or 5) seizure suspected of arrhythmic origin.•&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who refuse informed consent and to participate to the best ability in the study.&#xD;
&#xD;
        Patients who have structural heart disease or concomitant medical illness.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Koonlawee Nademanee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chulalongkorn University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carla Drew, BS</last_name>
    <phone>13104302613</phone>
    <email>carla@pacificrimep.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Koonlawee Nademanee, MD</last_name>
    <phone>66870708787</phone>
    <email>wee@pacificrimep.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Bumrungrad International Hospital</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Koonlawee Nademanee, MD</last_name>
    </contact>
    <investigator>
      <last_name>Koonlawee Nademanee, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Pacific Rim Electrophysiology Research Institute Data Coordinating Center</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Koonlawee Nademanee, MD</last_name>
      <phone>66870708787</phone>
      <email>koonlawee@pacificrimep.com</email>
    </contact>
    <investigator>
      <last_name>Koonlawee Nademanee, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <results_reference>
    <citation>Nademanee K, Raju H, de Noronha SV, Papadakis M, Robinson L, Rothery S, Makita N, Kowase S, Boonmee N, Vitayakritsirikul V, Ratanarapee S, Sharma S, van der Wal AC, Christiansen M, Tan HL, Wilde AA, Nogami A, Sheppard MN, Veerakul G, Behr ER. Fibrosis, Connexin-43, and Conduction Abnormalities in the Brugada Syndrome. J Am Coll Cardiol. 2015 Nov 3;66(18):1976-1986. doi: 10.1016/j.jacc.2015.08.862.</citation>
    <PMID>26516000</PMID>
  </results_reference>
  <results_reference>
    <citation>Nademanee K, Hocini M, Haissaguerre M. Epicardial substrate ablation for Brugada syndrome. Heart Rhythm. 2017 Mar;14(3):457-461. doi: 10.1016/j.hrthm.2016.12.001. Epub 2016 Dec 12. No abstract available.</citation>
    <PMID>27979714</PMID>
  </results_reference>
  <results_reference>
    <citation>Nademanee K, Veerakul G, Chandanamattha P, Chaothawee L, Ariyachaipanich A, Jirasirirojanakorn K, Likittanasombat K, Bhuripanyo K, Ngarmukos T. Prevention of ventricular fibrillation episodes in Brugada syndrome by catheter ablation over the anterior right ventricular outflow tract epicardium. Circulation. 2011 Mar 29;123(12):1270-9. doi: 10.1161/CIRCULATIONAHA.110.972612. Epub 2011 Mar 14.</citation>
    <PMID>21403098</PMID>
  </results_reference>
  <results_reference>
    <citation>Veerakul G, Nademanee K. Will we be able to cure brugada syndrome? Heart Rhythm. 2016 Nov;13(11):2159-2160. doi: 10.1016/j.hrthm.2016.08.025. Epub 2016 Aug 17. No abstract available.</citation>
    <PMID>27544747</PMID>
  </results_reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>October 6, 2022</last_update_submitted>
  <last_update_submitted_qc>October 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pacific Rim Electrophysiology Research Institute</investigator_affiliation>
    <investigator_full_name>Koonlawee Nademanee, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brugada Syndrome</mesh_term>
    <mesh_term>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/NCT03764592
org study id: PACIFICReri2
nct id: NCT03764592
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To determine the values and limitations of ECGI in guiding ablation and risk stratification
      in patients with BrS and Early Repolarization.
The investigators will study symptomatic BrS and ERs syndrome (N=25) and asymptomatic
      patients (N=25) age between 16-70 years old to determine values and limitations of
      non-invasive mapping using electrocardiographic imaging (ECGI) in identifying VF substrates
      as target sites for catheter ablations in patients with Brugada (BrS) and Early
      repolarization syndromes (ERS) and also determine the mechanisms of VF in BrS and ERs
      syndromes.
observational model: Cohort
time perspective: Prospective
measure: VF death
time frame: 3 years
description: ventricular fibrillation
arm group label: VF BrS/ERS patients
description: Only patients that diagnosed with BrS or ERS based on ECG criteria
intervention type: Other
intervention name: radiofrequency ablation
description: Symptomatic patients whose substrates were identified will undergo catheter ablation; asymptomatic patients will be followed without undergoing catheter ablation.
arm group label: VF BrS/ERS patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 70 Years
healthy volunteers: No
last name: Koonlawee Nademanee, MD
role: Principal Investigator
affiliation: Chulalongkorn University
last name: Carla Drew, BS
phone: 13104302613
email: carla@pacificrimep.com
last name: Koonlawee Nademanee, MD
phone: 66870708787
email: wee@pacificrimep.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Thailand
citation: Nademanee K, Raju H, de Noronha SV, Papadakis M, Robinson L, Rothery S, Makita N, Kowase S, Boonmee N, Vitayakritsirikul V, Ratanarapee S, Sharma S, van der Wal AC, Christiansen M, Tan HL, Wilde AA, Nogami A, Sheppard MN, Veerakul G, Behr ER. Fibrosis, Connexin-43, and Conduction Abnormalities in the Brugada Syndrome. J Am Coll Cardiol. 2015 Nov 3;66(18):1976-1986. doi: 10.1016/j.jacc.2015.08.862.
PMID: 26516000
citation: Nademanee K, Hocini M, Haissaguerre M. Epicardial substrate ablation for Brugada syndrome. Heart Rhythm. 2017 Mar;14(3):457-461. doi: 10.1016/j.hrthm.2016.12.001. Epub 2016 Dec 12. No abstract available.
PMID: 27979714
citation: Nademanee K, Veerakul G, Chandanamattha P, Chaothawee L, Ariyachaipanich A, Jirasirirojanakorn K, Likittanasombat K, Bhuripanyo K, Ngarmukos T. Prevention of ventricular fibrillation episodes in Brugada syndrome by catheter ablation over the anterior right ventricular outflow tract epicardium. Circulation. 2011 Mar 29;123(12):1270-9. doi: 10.1161/CIRCULATIONAHA.110.972612. Epub 2011 Mar 14.
PMID: 21403098
citation: Veerakul G, Nademanee K. Will we be able to cure brugada syndrome? Heart Rhythm. 2016 Nov;13(11):2159-2160. doi: 10.1016/j.hrthm.2016.08.025. Epub 2016 Aug 17. No abstract available.
PMID: 27544747
responsible party type: Principal Investigator
investigator affiliation: Pacific Rim Electrophysiology Research Institute
investigator full name: Koonlawee Nademanee, MD
investigator title: Principal Investigator
mesh term: Brugada Syndrome
mesh term: Syndrome
sharing ipd: No