<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/NCT02246790</url>
  </required_header>
  <id_info>
    <org_study_id>LABARFA</org_study_id>
    <nct_id>NCT02246790</nct_id>
  </id_info>
  <brief_title>Surgical Ablation of Long-standing Persistent AF During CABG</brief_title>
  <acronym>LABARFA</acronym>
  <official_title>Surgical Ablation of Long-standing Persistent Atrial Fibrillation During CABG Through Continuous Subcutaneous Monitoring</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>
      Purpose. Comparison of outcomes in patients underwent CABG combined with left atrial and&#xD;
      biatrial radiofrequency ablation of long-standing persistent atrial fibrillation.&#xD;
&#xD;
      Hypothesis of the study - patients with long-standing persistent atrial fibrillation and&#xD;
      coronary artery disease after CABG in combination with biatrial RFA have a better outcomes&#xD;
      for the freedom of AF compared with patients undergoing left atrial RFA during CABG.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single blinded prospective randomized study involving 116 patients with&#xD;
      long-standing persistent AF and coronary artery disease. 116 patients are required to have a&#xD;
      80% chance of detecting, as significant at the 5% level, an increase in the primary outcome&#xD;
      (freedom fro AF) measure by 12% in the biatrial group over left atrial group. Patients are&#xD;
      divided into two groups, group I - biatrial + CABG (58 patients), and group II - left atrial&#xD;
      + CABG (58 patients). Randomization is conducted by using accidental sampling before&#xD;
      operation. The blinding process is applied to a patient, who is informed about received&#xD;
      coronary artery bypass grafting, but don't know about kind of surgical ablation. Subcutaneous&#xD;
      cardiac monitor is implanted to all patients for cardiac rhythm monitoring.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>Phase 3</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>Freedom from atrial fibrillation</measure>
    <time_frame>up to 36 months</time_frame>
    <description>Freedom from AF. All cases of AF after surgical intervention.&#xD;
Atrial fibrillation is defined as atrial fibrillation paroxysm lasting at least 60 seconds. Patients with AF&gt;0.5% were classified as non-responders.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular events</measure>
    <time_frame>Within three years after surgery</time_frame>
    <description>All cases of stroke, cardiac infarction, thromboembolism, bleeding and death</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">116</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Biatrial radiofrequency ablation and CABG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Biatrial radiofrequency ablation during CABG</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Left atrial radiofrequency ablation and CABG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Left atrial radiofrequency ablation during CABG</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biatrial radiofrequency ablation and CABG</intervention_name>
    <description>Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant biatrial RFA during CPB.</description>
    <arm_group_label>Biatrial radiofrequency ablation and CABG</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Left atrial radiofrequency ablation and CABG</intervention_name>
    <description>Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant left atrial RFA during CPB.</description>
    <arm_group_label>Left atrial radiofrequency ablation and CABG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  American College of Cardiology (ACC)/ American Heart Association (AHA) Indications for&#xD;
             CABG&#xD;
&#xD;
          -  At least 2 ECG-verified (12-channel ECG, Holter telemetry) long-term persistent AF&#xD;
             within last 12 months&#xD;
&#xD;
          -  The patient's consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intolerance of antiarrhythmic drugs&#xD;
&#xD;
          -  Heart valve disease requiring invasive treatment&#xD;
&#xD;
          -  Left atria more than 6.5 cm&#xD;
&#xD;
          -  Prior cardiac surgery&#xD;
&#xD;
          -  Active pacemaker treatment&#xD;
&#xD;
          -  Active anti-arrhythmic treatment (AAD) class I and III&#xD;
&#xD;
          -  Contraindication to oral anticoagulant/heparin treatment&#xD;
&#xD;
          -  Ejection fraction less than 30 % (EF &lt; 30 %) assessed by transthoracic&#xD;
             echocardiography&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sardor Rakhmonov</last_name>
    <phone>+79231278557</phone>
    <email>sardor5507@mail.ru</email>
  </overall_contact>
  <location>
    <facility>
      <name>Meshalkin State Research Institute of Circulation Pathology</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630055</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sardor Rakhmonov</last_name>
      <phone>+79231278557</phone>
      <email>sardor5507@mail.ru</email>
    </contact>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>November 12, 2015</last_update_submitted>
  <last_update_submitted_qc>November 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Meshalkin Research Institute of Pathology of Circulation</investigator_affiliation>
    <investigator_full_name>Alexander Romanov</investigator_full_name>
    <investigator_title>Meshalkin Research Institute of Pathology of Circulation</investigator_title>
  </responsible_party>
  <keyword>ablation, CABG</keyword>
  <keyword>Long-standing persistent Atrial Fibrillation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <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/NCT02246790
org study id: LABARFA
nct id: NCT02246790
lead sponsor: 
has dmc: No
Purpose. Comparison of outcomes in patients underwent CABG combined with left atrial and
      biatrial radiofrequency ablation of long-standing persistent atrial fibrillation.

      Hypothesis of the study - patients with long-standing persistent atrial fibrillation and
      coronary artery disease after CABG in combination with biatrial RFA have a better outcomes
      for the freedom of AF compared with patients undergoing left atrial RFA during CABG.
This is a single blinded prospective randomized study involving 116 patients with
      long-standing persistent AF and coronary artery disease. 116 patients are required to have a
      80% chance of detecting, as significant at the 5% level, an increase in the primary outcome
      (freedom fro AF) measure by 12% in the biatrial group over left atrial group. Patients are
      divided into two groups, group I - biatrial + CABG (58 patients), and group II - left atrial
      + CABG (58 patients). Randomization is conducted by using accidental sampling before
      operation. The blinding process is applied to a patient, who is informed about received
      coronary artery bypass grafting, but don't know about kind of surgical ablation. Subcutaneous
      cardiac monitor is implanted to all patients for cardiac rhythm monitoring.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Freedom from atrial fibrillation
time frame: up to 36 months
description: Freedom from AF. All cases of AF after surgical intervention.
Atrial fibrillation is defined as atrial fibrillation paroxysm lasting at least 60 seconds. Patients with AF>0.5% were classified as non-responders.
measure: Cardiovascular events
time frame: Within three years after surgery
description: All cases of stroke, cardiac infarction, thromboembolism, bleeding and death
arm group label: Biatrial radiofrequency ablation and CABG
arm group type: Active Comparator
description: Biatrial radiofrequency ablation during CABG
arm group label: Left atrial radiofrequency ablation and CABG
arm group type: Active Comparator
description: Left atrial radiofrequency ablation during CABG
intervention type: Procedure
intervention name: Biatrial radiofrequency ablation and CABG
description: Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant biatrial RFA during CPB.
arm group label: Biatrial radiofrequency ablation and CABG
intervention type: Procedure
intervention name: Left atrial radiofrequency ablation and CABG
description: Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant left atrial RFA during CPB.
arm group label: Left atrial radiofrequency ablation and CABG
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Sardor Rakhmonov
phone: +79231278557
email: sardor5507@mail.ru
facility: 
status: Recruiting
contact: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: Meshalkin Research Institute of Pathology of Circulation
investigator full name: Alexander Romanov
investigator title: Meshalkin Research Institute of Pathology of Circulation
mesh term: Coronary Artery Disease
mesh term: Atrial Fibrillation