<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/NCT01711047</url>
  </required_header>
  <id_info>
    <org_study_id>09/H0605/97</org_study_id>
    <nct_id>NCT01711047</nct_id>
  </id_info>
  <brief_title>Benefit of CFAE Ablation</brief_title>
  <acronym>BOCA</acronym>
  <official_title>A Study to Investigate the Benefit Of Complex Fractionated Atrial Electrogram (CFAE) Ablation in Addition to Circumferential Pulmonary Vein and Linear Ablations in the Treatment of Persistent Atrial Fibrillation. (BOCA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oxford University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oxford University Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The optimal strategy for catheter ablation of persistent atrial fibrillation is not clearly&#xD;
      defined. This study investigates if Complex Fractionated Atrial Electrogram (CFAE) ablation&#xD;
      in addition to pulmonary vein isolation and linear ablations improves single procedural&#xD;
      success rate over a 12 month follow up period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2010</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Single procedural success rate (free from AF off anti-arrhythmic drugs)</measure>
    <time_frame>12 MONTHS</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Multiple procedure success rate</measure>
    <time_frame>12 months after last ablation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>30 days of procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of AF termination</measure>
    <time_frame>Time 0</time_frame>
    <description>This information will be recorded immediately after the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>recurrence of atrial fibrillation or organised atrial tachycardia</measure>
    <time_frame>12 months after the last procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ablation time</measure>
    <time_frame>Time 0</time_frame>
    <description>This information will be recorded immediately after the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure time</measure>
    <time_frame>Time 0</time_frame>
    <description>This information will be recorded immediately after the procedure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Persistent Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>PVI + Linear ablation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm A: patients have PVI and roof and mitral isthmus lines</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PVI + linear ablation + CFAE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm B: patients have PVI + roof and mitral isthmus lines and CFAE ablation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radiofrequency catheter Ablation</intervention_name>
    <description>In this arm, catheter ablation would be performed in the left atrium and would include pulmonary vein isolation and linear ablations (roof and mitral isthmus lines)</description>
    <arm_group_label>PVI + Linear ablation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radiofrequency catheter ablation</intervention_name>
    <description>In this arm, catheter ablation would be performed in the left atrium, including pulmonary vein isolation, linear ablations (roof and mitral isthmus lines) and Complex Fractionated Atrial Electrograms (CFAE) ablation.</description>
    <arm_group_label>PVI + linear ablation + CFAE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  persistent atrial fibrillation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous catheter or surgical ablation for atrial fibrillation&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Royal Bournemouth Hospital</name>
      <address>
        <city>Bournemouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Radcliffe Hospital</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>October 11, 2017</last_update_submitted>
  <last_update_submitted_qc>October 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>catheter ablation</keyword>
  <keyword>atrial fibrillation</keyword>
  <keyword>pulmonary vein isolation</keyword>
  <keyword>linear ablation</keyword>
  <keyword>CFAE ablation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <!-- 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/NCT01711047
org study id: 09/H0605/97
nct id: NCT01711047
lead sponsor: 
collaborator: 
has dmc: Yes
The optimal strategy for catheter ablation of persistent atrial fibrillation is not clearly
      defined. This study investigates if Complex Fractionated Atrial Electrogram (CFAE) ablation
      in addition to pulmonary vein isolation and linear ablations improves single procedural
      success rate over a 12 month follow up period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Single procedural success rate (free from AF off anti-arrhythmic drugs)
time frame: 12 MONTHS
measure: Multiple procedure success rate
time frame: 12 months after last ablation
measure: Complication rate
time frame: 30 days of procedure
measure: Percentage of AF termination
time frame: Time 0
description: This information will be recorded immediately after the procedure.
measure: recurrence of atrial fibrillation or organised atrial tachycardia
time frame: 12 months after the last procedure
measure: Ablation time
time frame: Time 0
description: This information will be recorded immediately after the procedure.
measure: Procedure time
time frame: Time 0
description: This information will be recorded immediately after the procedure
arm group label: PVI + Linear ablation
arm group type: Active Comparator
description: Arm A: patients have PVI and roof and mitral isthmus lines
arm group label: PVI + linear ablation + CFAE
arm group type: Active Comparator
description: Arm B: patients have PVI + roof and mitral isthmus lines and CFAE ablation
intervention type: Procedure
intervention name: Radiofrequency catheter Ablation
description: In this arm, catheter ablation would be performed in the left atrium and would include pulmonary vein isolation and linear ablations (roof and mitral isthmus lines)
arm group label: PVI + Linear ablation
intervention type: Procedure
intervention name: Radiofrequency catheter ablation
description: In this arm, catheter ablation would be performed in the left atrium, including pulmonary vein isolation, linear ablations (roof and mitral isthmus lines) and Complex Fractionated Atrial Electrograms (CFAE) ablation.
arm group label: PVI + linear ablation + CFAE
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Atrial Fibrillation