<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/NCT01703247</url>
  </required_header>
  <id_info>
    <org_study_id>GP-LL-AF</org_study_id>
    <nct_id>NCT01703247</nct_id>
  </id_info>
  <brief_title>Ganglionated Plexi Ablation Combined With Pulmonary Vein Isolation</brief_title>
  <official_title>Ganglionated Plexi Ablation vs Linear Ablation in Patients Undergoing Pulmonary Vein Isolation for Persistent/Longstanding Persistent Atrial Fibrillation: A Randomized Comparison</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meshalkin Research Institute of Pathology of Circulation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meshalkin Research Institute of Pathology of Circulation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators have conducted a prospective, double-blind, randomized study to assess the&#xD;
      comparative safety and efficacy of two different ablation strategies, PVI plus linear lesions&#xD;
      (LL) versus PVI plus GP ablation, in patients with persistent or longstanding persistent AF.&#xD;
      Results were assessed after follow-up of at least 3 years with the use of an implanted&#xD;
      monitoring device (IMD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2008</start_date>
  <completion_date type="Actual">May 2009</completion_date>
  <primary_completion_date type="Actual">January 2009</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">264</enrollment>
  <condition>Persistent Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>PVI+LL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Circumferential PVI was accomplished and then additional ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the LA between the two superior PVs (roof). Finally, patients underwent cavo-tricuspid isthmus ablation in the right atrium.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PVI+GP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>To accomplish ganglionated plexi ablation, LA target sites were identified as the anatomic locations where vagal reflexes were evoked by transcatheter high-frequency stimulation (HFS). Rectangular electrical stimuli were delivered at a frequency of 20-50 Hz, output amplitude 15 V and pulse duration of 10 ms, for 5 sec (Stimulator B-53, Biotok Inc, Russia).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pulmonary vein isolation</intervention_name>
    <arm_group_label>PVI+GP</arm_group_label>
    <arm_group_label>PVI+LL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ganglionated plexi ablation</intervention_name>
    <arm_group_label>PVI+GP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Linear Lesion Ablation</intervention_name>
    <arm_group_label>PVI+LL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Persistent and longstanding persistent AF&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  congestive heart failure&#xD;
&#xD;
          -  LV ejection fraction &lt; 35%&#xD;
&#xD;
          -  left atrial diameter &gt; 60 mm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Evgeny Pokushalov, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>State Research Institute of Circulation Pathology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>State Research Institute of CIrculation Pathology</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630055</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <link>
    <url>http://www.meshalkin.ru/</url>
    <description>State Research Institute of Circulation Pathology Official Site</description>
  </link>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>October 9, 2012</last_update_submitted>
  <last_update_submitted_qc>October 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Arrhythmias</keyword>
  <keyword>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/NCT01703247
org study id: GP-LL-AF
nct id: NCT01703247
lead sponsor: 
has dmc: No
The investigators have conducted a prospective, double-blind, randomized study to assess the
      comparative safety and efficacy of two different ablation strategies, PVI plus linear lesions
      (LL) versus PVI plus GP ablation, in patients with persistent or longstanding persistent AF.
      Results were assessed after follow-up of at least 3 years with the use of an implanted
      monitoring device (IMD).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia
time frame: 3 years
arm group label: PVI+LL
arm group type: Active Comparator
description: Circumferential PVI was accomplished and then additional ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the LA between the two superior PVs (roof). Finally, patients underwent cavo-tricuspid isthmus ablation in the right atrium.
arm group label: PVI+GP
arm group type: Active Comparator
description: To accomplish ganglionated plexi ablation, LA target sites were identified as the anatomic locations where vagal reflexes were evoked by transcatheter high-frequency stimulation (HFS). Rectangular electrical stimuli were delivered at a frequency of 20-50 Hz, output amplitude 15 V and pulse duration of 10 ms, for 5 sec (Stimulator B-53, Biotok Inc, Russia).
intervention type: Procedure
intervention name: Pulmonary vein isolation
arm group label: PVI+GP
arm group label: PVI+LL
intervention type: Procedure
intervention name: Ganglionated plexi ablation
arm group label: PVI+GP
intervention type: Procedure
intervention name: Linear Lesion Ablation
arm group label: PVI+LL
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Evgeny Pokushalov, MD, PhD
role: Principal Investigator
affiliation: State Research Institute of Circulation Pathology
facility: 
country: Russian Federation
url: http://www.meshalkin.ru/
description: State Research Institute of Circulation Pathology Official Site
responsible party type: Sponsor
mesh term: Atrial Fibrillation