<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/NCT04405258</url>
  </required_header>
  <id_info>
    <org_study_id>947</org_study_id>
    <nct_id>NCT04405258</nct_id>
  </id_info>
  <brief_title>Left Atrial Posterior Wall Additional Isolation for Persistent Atrial Fibrillation Trial</brief_title>
  <acronym>LEAP-AF</acronym>
  <official_title>Randomized Clinical Trial of Additional Left Atrial Posterior Wall Isolation for Persistent Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute for Clinical Effectiveness, Japan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute for Clinical Effectiveness, Japan</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>
      The purpose for this study is to determine whether left posterior wall isolation (PWI) in&#xD;
      addition to pulmonary vein isolation (PVI) is effective as ablation strategy for persistent&#xD;
      atrial fibrillation (AF).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PVI is cornerstone of AF ablation. However, clinical outcome of only PVI in patients with&#xD;
      persistent AF is insufficient due to AF substrate extending to left atrium. Strategy of&#xD;
      catheter ablation for persistent AF is not established despite attempts of numerous left&#xD;
      atrial substrate modifications. Additional PWI on PVI is one of expected effective strategies&#xD;
      for persistent AF, because PW originated from common tissue of PV and is considered to play a&#xD;
      part in AF trigger and maintenance. However, this strategy is also not established in the&#xD;
      recent international consensus statement. Following two reasons are considered. One is the&#xD;
      procedural difficulty in creating durable PWI, and another is the existence of patients who&#xD;
      can recover by only PVI. The latest technology, ablation index, can create durable PVI, and&#xD;
      may create durable PWI. Several reports suggested that PVI only strategy was sufficient in&#xD;
      the patients with persistent AF who could maintain sinus rhythm after pharmacological or&#xD;
      electrical cardioversion. Therefore, we planed this randomized clinical trial that compared&#xD;
      between PVI alone and additional PWI on PVI using ablation index in the patients with&#xD;
      persistent AF without pharmacological sinus rhythm conversion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
  <phase>Phase 4</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence of atrial tachyarrhythmia after 90-day blanking period of catheter ablation</measure>
    <time_frame>18 months</time_frame>
    <description>Recurrence of atrial tachyarrhythmia is defined atrial arrhythmia that needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of catheter ablation</measure>
    <time_frame>18 months</time_frame>
    <description>Recurrence of atrial fibrillation or atrial tachycardia needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of atrial fibrillation or atrial tachycardia within 90-day after catheter ablation</measure>
    <time_frame>90 days</time_frame>
    <description>Recurrence of atrial fibrillation or atrial tachycardia needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Repeated ablation of atrial tachyarrhythmia</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of repeated ablation</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial Fibrillation Quality of Life Questionnaire</measure>
    <time_frame>18 months</time_frame>
    <description>Atrial Fibrillation Quality of Life Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications of ablation procedure</measure>
    <time_frame>1 month</time_frame>
    <description>Complications of ablation procedure includes death, cardiac tamponade, pericardial effusion, systemic embolism, symptomatic strokes, hematoma, A-V shunt, pericarditis, phrenic nerve paralysis, A-V block, procedure-related infections, heart failure, atrio-esophageal fistula, esophageal vagus nerve injury</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">268</enrollment>
  <condition>Persistent Atrial Fibrillation</condition>
  <condition>Catheter Ablation</condition>
  <condition>Pulmonary Vein Isolation</condition>
  <condition>Posterior Wall Isolation</condition>
  <arm_group>
    <arm_group_label>PVI alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PVI and PWI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pulmonary vein isolation</intervention_name>
    <description>Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation</description>
    <arm_group_label>PVI alone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Left posterior wall isolation</intervention_name>
    <description>Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation</description>
    <arm_group_label>PVI and PWI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for first catheter ablation of persistent atrial fibrillation&#xD;
&#xD;
          -  Patients without conversion to sinus rhythm within 30 days after antiarrhythmic drug&#xD;
             administration&#xD;
&#xD;
          -  Patients with persisting duration of atrial fibrillation less than 3 years&#xD;
&#xD;
          -  Patients with left atrial diameter less than 50mm&#xD;
&#xD;
          -  Patients who can be followed up for 18 months&#xD;
&#xD;
          -  Patients with written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who can not be received adequate anticoagulation therapy&#xD;
&#xD;
          -  Patients with history of myocardial infarction within 6 months&#xD;
&#xD;
          -  Patients with history of open heart surgery&#xD;
&#xD;
          -  Patients scheduled for open heart surgery&#xD;
&#xD;
          -  Patients with severe valvular heart disease&#xD;
&#xD;
          -  Patients during pregnancy&#xD;
&#xD;
          -  Patients with expected life expectancy less than 1 year due to malignancy or&#xD;
             non-cardiovascular disease&#xD;
&#xD;
          -  Patients considered unsuitable for study by the attending physician&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Keisuke Okawa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kagawa Prefectural Central Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Keisuke Okawa, MD</last_name>
    <phone>+81-87-811-3333</phone>
    <phone_ext>5555</phone_ext>
    <email>k-ookawa@chp-kagawa.jp</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Masahiko Takahashi, MD</last_name>
    <phone>+81-87-811-3333</phone>
    <phone_ext>5558</phone_ext>
    <email>ma-takahashi@chp-kagawa.jp</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kagawa Prefectural Central Hospital</name>
      <address>
        <city>Takamatsu</city>
        <state>Kagawa</state>
        <zip>760-8557</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Keisuke Okawa, MD</last_name>
      <phone>+81-87-811-3333</phone>
      <phone_ext>5555</phone_ext>
      <email>k-ookawa@chp-kagawa.jp</email>
    </contact>
    <contact_backup>
      <last_name>Masahiko Takahashi, MD</last_name>
      <phone>+81-87-811-3333</phone>
      <phone_ext>5558</phone_ext>
      <email>ma-takahashi@chp-kagawa.jp</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>April 1, 2023</last_update_submitted>
  <last_update_submitted_qc>April 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Persistent atrial fibrillation</keyword>
  <keyword>Catheter ablation</keyword>
  <keyword>Pulmonary vein isolation</keyword>
  <keyword>Posterior wall isolation</keyword>
  <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>
    <ipd_description>The data that support the findings of this study will be available from the data center upon reasonable request.</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/NCT04405258
org study id: 947
nct id: NCT04405258
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose for this study is to determine whether left posterior wall isolation (PWI) in
      addition to pulmonary vein isolation (PVI) is effective as ablation strategy for persistent
      atrial fibrillation (AF).
PVI is cornerstone of AF ablation. However, clinical outcome of only PVI in patients with
      persistent AF is insufficient due to AF substrate extending to left atrium. Strategy of
      catheter ablation for persistent AF is not established despite attempts of numerous left
      atrial substrate modifications. Additional PWI on PVI is one of expected effective strategies
      for persistent AF, because PW originated from common tissue of PV and is considered to play a
      part in AF trigger and maintenance. However, this strategy is also not established in the
      recent international consensus statement. Following two reasons are considered. One is the
      procedural difficulty in creating durable PWI, and another is the existence of patients who
      can recover by only PVI. The latest technology, ablation index, can create durable PVI, and
      may create durable PWI. Several reports suggested that PVI only strategy was sufficient in
      the patients with persistent AF who could maintain sinus rhythm after pharmacological or
      electrical cardioversion. Therefore, we planed this randomized clinical trial that compared
      between PVI alone and additional PWI on PVI using ablation index in the patients with
      persistent AF without pharmacological sinus rhythm conversion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Recurrence of atrial tachyarrhythmia after 90-day blanking period of catheter ablation
time frame: 18 months
description: Recurrence of atrial tachyarrhythmia is defined atrial arrhythmia that needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.
measure: Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of catheter ablation
time frame: 18 months
description: Recurrence of atrial fibrillation or atrial tachycardia needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.
measure: Recurrence of atrial fibrillation or atrial tachycardia within 90-day after catheter ablation
time frame: 90 days
description: Recurrence of atrial fibrillation or atrial tachycardia needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds.
measure: Repeated ablation of atrial tachyarrhythmia
time frame: 18 months
measure: Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of repeated ablation
time frame: 18 months
measure: Atrial Fibrillation Quality of Life Questionnaire
time frame: 18 months
description: Atrial Fibrillation Quality of Life Questionnaire
measure: Complications of ablation procedure
time frame: 1 month
description: Complications of ablation procedure includes death, cardiac tamponade, pericardial effusion, systemic embolism, symptomatic strokes, hematoma, A-V shunt, pericarditis, phrenic nerve paralysis, A-V block, procedure-related infections, heart failure, atrio-esophageal fistula, esophageal vagus nerve injury
arm group label: PVI alone
arm group type: Active Comparator
description: Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation
arm group label: PVI and PWI
arm group type: Active Comparator
description: Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation
intervention type: Procedure
intervention name: Pulmonary vein isolation
description: Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation
arm group label: PVI alone
intervention type: Procedure
intervention name: Left posterior wall isolation
description: Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation
arm group label: PVI and PWI
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Keisuke Okawa, MD
role: Principal Investigator
affiliation: Kagawa Prefectural Central Hospital
last name: Keisuke Okawa, MD
phone: +81-87-811-3333
phone ext: 5555
email: k-ookawa@chp-kagawa.jp
last name: Masahiko Takahashi, MD
phone: +81-87-811-3333
phone ext: 5558
email: ma-takahashi@chp-kagawa.jp
facility: 
status: Recruiting
contact: 
contact backup: 
country: Japan
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No
ipd description: The data that support the findings of this study will be available from the data center upon reasonable request.