<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/NCT02984371</url>
  </required_header>
  <id_info>
    <org_study_id>ASTR_0789</org_study_id>
    <nct_id>NCT02984371</nct_id>
  </id_info>
  <brief_title>Epicardial Fat Pads Ablation During Coronary Surgery</brief_title>
  <official_title>Ablation of the Epicardial Fat Pads to Treat Paroxysmal Atrial Fibrillation During Coronary Artery Bypass Grafting</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>
  <brief_summary>
    <textblock>
      The aim of this prospective randomized study was to assess the efficacy of ablation of the&#xD;
      ganglionated plexi localized in the epicardial fat pads for preventing recurrences of atrial&#xD;
      tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery&#xD;
      bypass grafting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2016</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>Recurrence of any atrial tachyarrhythmia, including atrial fibrillation and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug</measure>
    <time_frame>12 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>atrial fibrillation burden</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of congestive heart failure</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of sustained ventricular arrhythmias</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rehospitalization</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stroke or transient ischemic attack</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of Deaths</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">264</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Ischemic Heart Disease</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Coronary artery bypass grafting + epicardial ganglionated plexi ablation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Coronary artery bypass grafting</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Coronary artery bypass grafting</intervention_name>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Epicardial ganglionated plexi ablation</intervention_name>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>implantable loop recorder</intervention_name>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of paroxysmal atrial fibrillation (recurrent episodes for at least 1 years,&#xD;
             with 2 documented episodes over the last 6 months)&#xD;
&#xD;
          -  Indication for cardiac surgery (e.g. coronary artery bypass grafting, valve&#xD;
             repair/replacement) according to the American College of Cardiology/American Heart&#xD;
             Association (ACC/AHA) guidelines for cardiac surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Previous heart surgery or atrial fibrillation ablation procedure Emergency coronary artery&#xD;
        bypass grafting Unstable angina or heart failure Persistent atrial fibrillation Planned&#xD;
        maze procedure or pulmonary vein isolation Unwillingness to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Alexander Romanov, MD, PhD</last_name>
    <phone>+73833327655</phone>
    <email>abromanov@mail.ru</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Evgeny Pokushalov, MD, PhD</last_name>
    <phone>+73833327655</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630055</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Evgeny Pokushalov, MD, PhD</last_name>
      <phone>+79139254858</phone>
      <email>E.Pokushalov@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Evgeny Pokushalov, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alexander Romanov, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alexander Cherniavskiy, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cardiology Research Institute</name>
      <address>
        <city>Tomsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boris Kozlov, MD, PhD</last_name>
      <phone>+7(3822) 56 12 32</phone>
      <email>cardio@cardio-tomsk.ru</email>
    </contact>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>December 2, 2016</last_update_submitted>
  <last_update_submitted_qc>December 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>atrial fibrillation</keyword>
  <keyword>ganglionated plexi</keyword>
  <keyword>ischemic heart disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Artery Disease</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/NCT02984371
org study id: ASTR_0789
nct id: NCT02984371
lead sponsor: 
The aim of this prospective randomized study was to assess the efficacy of ablation of the
      ganglionated plexi localized in the epicardial fat pads for preventing recurrences of atrial
      tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery
      bypass grafting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Recurrence of any atrial tachyarrhythmia, including atrial fibrillation and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug
time frame: 12 month
measure: atrial fibrillation burden
time frame: 12 month
measure: incidence of congestive heart failure
time frame: 12 month
measure: incidence of sustained ventricular arrhythmias
time frame: 12 month
measure: rehospitalization
time frame: 12 month
measure: stroke or transient ischemic attack
time frame: 12 month
measure: number of Deaths
time frame: 12 month
arm group label: Group 1
arm group type: Experimental
description: Coronary artery bypass grafting + epicardial ganglionated plexi ablation
arm group label: Group 2
arm group type: Active Comparator
description: Coronary artery bypass grafting
intervention type: Procedure
intervention name: Coronary artery bypass grafting
arm group label: Group 1
arm group label: Group 2
intervention type: Procedure
intervention name: Epicardial ganglionated plexi ablation
arm group label: Group 1
intervention type: Procedure
intervention name: implantable loop recorder
arm group label: Group 1
arm group label: Group 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Alexander Romanov, MD, PhD
phone: +73833327655
email: abromanov@mail.ru
last name: Evgeny Pokushalov, MD, PhD
phone: +73833327655
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Heart Diseases
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease