<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/NCT03836092</url>
  </required_header>
  <id_info>
    <org_study_id>PACIFICRERI3</org_study_id>
    <nct_id>NCT03836092</nct_id>
  </id_info>
  <brief_title>ECGI in Patients With Persistent Atrial Fibrillation</brief_title>
  <official_title>Identification of AF Triggers, Initiators and Perpetuators by Electro Cardio-Graphic Imaging (ECGI) in Patients With Persistent Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pacific Rim Electrophysiology Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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 persistent atrial fibrillation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patient population will include symptomatic persistent AF patients (N=50). The total of&#xD;
      fifty patients will be studied to determine:&#xD;
&#xD;
        -  The values and limitations of ECGI in identifying atrial fibrillation (AF) triggers, AF&#xD;
           initiators and AF perpetuators as targets sites for catheter ablations in patients with&#xD;
           persistent AF.&#xD;
&#xD;
        -  The mechanisms of residual atrial tachycardia/flutter (Res-AT/AFl) after AF substrate&#xD;
           ablations by targeting complex fractionated atrial electrograms (CFAE).&#xD;
&#xD;
        -  If there is a relationship between primary CFAE sites and driver sites or other distinct&#xD;
           patterns from the ECGI mapping system.&#xD;
&#xD;
        -  The rate of AF termination to sinus rhythm after ablation at target sites identified by&#xD;
           ECGI&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 23, 2018</start_date>
  <completion_date type="Actual">April 1, 2022</completion_date>
  <primary_completion_date type="Actual">January 1, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Freedom from Atrial Fibrillation</measure>
    <time_frame>1 year</time_frame>
    <description>termination via ablation from atrial fibrillation during follow up period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>termination via ablation from atrial fibrillation during procedure</measure>
    <time_frame>over 6 months</time_frame>
    <description>Termination of AF to NSR during procedure</description>
  </secondary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Atrial Fibrillation</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radiofrequency ablation</intervention_name>
    <description>RF applications were delivered with a maximal temperature of 43°C at the catheter tip (SmartTouch Navistar Thermocool catheter) and at the power between 25-50 watts. The primary end points during RF ablation were either complete elimination of areas with CFAE or conversion of AF to normal sinus rhythm (SR). When areas with CFAE were completely eliminated but the atrial arrhythmias persisted (organized atrial flutter or atrial tachycardia), they were subsequently mapped and ablated (occasionally in conjunction with ibutilide, 1 - 2 mgs intravenously over 10 minutes).</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patient population will include symptomatic persistent AF patients (N=50). The total of&#xD;
        fifty patients will be studied.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients are diagnosed as persistent AF. Persistent AF was defined as continuous AF&#xD;
             from 7 days to 12 months and long- lasting AF beyond twelve months.&#xD;
&#xD;
          -  Patients who are symptomatic&#xD;
&#xD;
          -  Patients who are willing to sign consent and be followed post procedure in an out-&#xD;
             patient arrhythmia clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18 years or over 85 years of age.&#xD;
&#xD;
          -  Patients with chronic alcoholism.&#xD;
&#xD;
          -  Recent myocardial infarction within one month of the study.&#xD;
&#xD;
          -  Significant debilitating diseases or a terminal disease.&#xD;
&#xD;
          -  Patients with documented left atrial thrombus.&#xD;
&#xD;
          -  Medical or mental conditions precluding a long-term follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bumrungrad International Hospital</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <results_reference>
    <citation>Nademanee K, McKenzie J, Kosar E, Schwab M, Sunsaneewitayakul B, Vasavakul T, Khunnawat C, Ngarmukos T. A new approach for catheter ablation of atrial fibrillation: mapping of the electrophysiologic substrate. J Am Coll Cardiol. 2004 Jun 2;43(11):2044-53. doi: 10.1016/j.jacc.2003.12.054.</citation>
    <PMID>15172410</PMID>
  </results_reference>
  <results_reference>
    <citation>Haissaguerre M, Hocini M, Denis A, Shah AJ, Komatsu Y, Yamashita S, Daly M, Amraoui S, Zellerhoff S, Picat MQ, Quotb A, Jesel L, Lim H, Ploux S, Bordachar P, Attuel G, Meillet V, Ritter P, Derval N, Sacher F, Bernus O, Cochet H, Jais P, Dubois R. Driver domains in persistent atrial fibrillation. Circulation. 2014 Aug 12;130(7):530-8. doi: 10.1161/CIRCULATIONAHA.113.005421. Epub 2014 Jul 15.</citation>
    <PMID>25028391</PMID>
  </results_reference>
  <results_reference>
    <citation>Conti S, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P, Verma A. Effect of Different Cutpoints for Defining Success Post-Catheter Ablation for Persistent Atrial Fibrillation: A Substudy of the STAR AF II Trial. JACC Clin Electrophysiol. 2017 May;3(5):522-523. doi: 10.1016/j.jacep.2016.12.006. Epub 2017 May 15. No abstract available.</citation>
    <PMID>29759610</PMID>
  </results_reference>
  <results_reference>
    <citation>Oketani N, Seitz J, Salazar M, Pisapia A, Kalifa J, Smit JJ, Nademanee K. Ablation of complex fractionated electrograms is useful for catheter ablation of persistent atrial fibrillation: Protagonist point of view. Heart Rhythm. 2016 Oct;13(10):2098-100. doi: 10.1016/j.hrthm.2016.06.036. Epub 2016 Jul 1. No abstract available.</citation>
    <PMID>27374307</PMID>
  </results_reference>
  <results_reference>
    <citation>Nademanee K, Amnueypol M, Lee F, Drew CM, Suwannasri W, Schwab MC, Veerakul G. Benefits and risks of catheter ablation in elderly patients with atrial fibrillation. Heart Rhythm. 2015 Jan;12(1):44-51. doi: 10.1016/j.hrthm.2014.09.049. Epub 2014 Oct 11.</citation>
    <PMID>25257091</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>April 9, 2022</last_update_submitted>
  <last_update_submitted_qc>April 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 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>Atrial Fibrillation</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/NCT03836092
org study id: PACIFICRERI3
nct id: NCT03836092
lead sponsor: 
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 persistent atrial fibrillation.
The patient population will include symptomatic persistent AF patients (N=50). The total of
      fifty patients will be studied to determine:

        -  The values and limitations of ECGI in identifying atrial fibrillation (AF) triggers, AF
           initiators and AF perpetuators as targets sites for catheter ablations in patients with
           persistent AF.

        -  The mechanisms of residual atrial tachycardia/flutter (Res-AT/AFl) after AF substrate
           ablations by targeting complex fractionated atrial electrograms (CFAE).

        -  If there is a relationship between primary CFAE sites and driver sites or other distinct
           patterns from the ECGI mapping system.

        -  The rate of AF termination to sinus rhythm after ablation at target sites identified by
           ECGI
observational model: Cohort
time perspective: Prospective
measure: Freedom from Atrial Fibrillation
time frame: 1 year
description: termination via ablation from atrial fibrillation during follow up period
measure: termination via ablation from atrial fibrillation during procedure
time frame: over 6 months
description: Termination of AF to NSR during procedure
intervention type: Procedure
intervention name: Radiofrequency ablation
description: RF applications were delivered with a maximal temperature of 43°C at the catheter tip (SmartTouch Navistar Thermocool catheter) and at the power between 25-50 watts. The primary end points during RF ablation were either complete elimination of areas with CFAE or conversion of AF to normal sinus rhythm (SR). When areas with CFAE were completely eliminated but the atrial arrhythmias persisted (organized atrial flutter or atrial tachycardia), they were subsequently mapped and ablated (occasionally in conjunction with ibutilide, 1 - 2 mgs intravenously over 10 minutes).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Thailand
citation: Nademanee K, McKenzie J, Kosar E, Schwab M, Sunsaneewitayakul B, Vasavakul T, Khunnawat C, Ngarmukos T. A new approach for catheter ablation of atrial fibrillation: mapping of the electrophysiologic substrate. J Am Coll Cardiol. 2004 Jun 2;43(11):2044-53. doi: 10.1016/j.jacc.2003.12.054.
PMID: 15172410
citation: Haissaguerre M, Hocini M, Denis A, Shah AJ, Komatsu Y, Yamashita S, Daly M, Amraoui S, Zellerhoff S, Picat MQ, Quotb A, Jesel L, Lim H, Ploux S, Bordachar P, Attuel G, Meillet V, Ritter P, Derval N, Sacher F, Bernus O, Cochet H, Jais P, Dubois R. Driver domains in persistent atrial fibrillation. Circulation. 2014 Aug 12;130(7):530-8. doi: 10.1161/CIRCULATIONAHA.113.005421. Epub 2014 Jul 15.
PMID: 25028391
citation: Conti S, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P, Verma A. Effect of Different Cutpoints for Defining Success Post-Catheter Ablation for Persistent Atrial Fibrillation: A Substudy of the STAR AF II Trial. JACC Clin Electrophysiol. 2017 May;3(5):522-523. doi: 10.1016/j.jacep.2016.12.006. Epub 2017 May 15. No abstract available.
PMID: 29759610
citation: Oketani N, Seitz J, Salazar M, Pisapia A, Kalifa J, Smit JJ, Nademanee K. Ablation of complex fractionated electrograms is useful for catheter ablation of persistent atrial fibrillation: Protagonist point of view. Heart Rhythm. 2016 Oct;13(10):2098-100. doi: 10.1016/j.hrthm.2016.06.036. Epub 2016 Jul 1. No abstract available.
PMID: 27374307
citation: Nademanee K, Amnueypol M, Lee F, Drew CM, Suwannasri W, Schwab MC, Veerakul G. Benefits and risks of catheter ablation in elderly patients with atrial fibrillation. Heart Rhythm. 2015 Jan;12(1):44-51. doi: 10.1016/j.hrthm.2014.09.049. Epub 2014 Oct 11.
PMID: 25257091
responsible party type: Principal Investigator
investigator affiliation: Pacific Rim Electrophysiology Research Institute
investigator full name: Koonlawee Nademanee, MD
investigator title: Principal Investigator
mesh term: Atrial Fibrillation
sharing ipd: No