<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/NCT02246803</url>
  </required_header>
  <id_info>
    <org_study_id>AF-Progress</org_study_id>
    <nct_id>NCT02246803</nct_id>
  </id_info>
  <brief_title>The Assessment of Progression of Paroxysmal AF After CABG</brief_title>
  <official_title>The Assessment of Progression of Paroxysmal Atrial Fibrillation in Patients After Coronary Artery Bypass Grafting 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>
      The aim of this study is a comparative evaluation of progression of paroxysmal atrial&#xD;
      fibrillation in patients with coronary artery disease after isolated CABG and CABG combined&#xD;
      with pulmonary vein isolation.&#xD;
&#xD;
      Hypothesis of the study - patients with paroxysmal atrial fibrillation and coronary artery&#xD;
      disease after CABG in combination with isolation of the pulmonary veins have a better&#xD;
      outcomes for the progression of AF compared with patients undergoing isolated CABG.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single blinded prospective randomized study involving 72 patients with paroxysmal&#xD;
      AF and coronary artery disease. 72 patients are required to have a 80% chance of detecting,&#xD;
      as significant at the 5% level, an increase in the primary outcome measure by 10% in the CABG&#xD;
      + pulmonary veins isolation group over isolated CABG group. Patients are divided into two&#xD;
      groups, group I - isolated CABG (36 patients), and group II - CABG and pulmonary veins&#xD;
      isolation (36 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 pulmonary vein isolation. 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>January 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>Progression of atrial fibrillation</measure>
    <time_frame>up to 36 months</time_frame>
    <description>Combined indicator consist of recurrence of AF, increased frequency of AF, progression to persistent AF.&#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>Hospitalization due to atrial fibrillation after surgery</measure>
    <time_frame>Within three years after surgery</time_frame>
    <description>All cases of hospitalization due to atrial fibrillation after surgery</description>
  </secondary_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">72</enrollment>
  <condition>Paroxysmal Atrial Fibrillation, Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>CABG+pulmonary vein isolation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CABG+pulmonary vein isolation procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Isolated CABG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Isolated CABG procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CABG+Pulmonary vein isolation procedure</intervention_name>
    <description>Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion. Concomitant pulmonary vein isolation in CBP prior to occlusion and CABG</description>
    <arm_group_label>CABG+pulmonary vein isolation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Isolated CABG</intervention_name>
    <description>Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion.</description>
    <arm_group_label>Isolated CABG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American College of Cardiology (ACC)/ American Heart Association (AHA) -Indications&#xD;
             for CABG&#xD;
&#xD;
          -  At least 2 ECG-verified (12-channel ECG, Holter telemetry) symptomatic paroxysmal&#xD;
             atrial fibrillation episodes 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>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Julia Kareva</last_name>
    <phone>+79069952839</phone>
    <email>julia11108@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>Julia Kareva, PhD</last_name>
      <phone>+79069952839</phone>
      <email>julia11108@mail.ru</email>
    </contact>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>September 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>September 21, 2015</last_update_submitted>
  <last_update_submitted_qc>September 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 23, 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>paroxysmal atrial fibrillation, CABG, pulmonary vein isolation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</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/NCT02246803
org study id: AF-Progress
nct id: NCT02246803
lead sponsor: 
has dmc: No
The aim of this study is a comparative evaluation of progression of paroxysmal atrial
      fibrillation in patients with coronary artery disease after isolated CABG and CABG combined
      with pulmonary vein isolation.

      Hypothesis of the study - patients with paroxysmal atrial fibrillation and coronary artery
      disease after CABG in combination with isolation of the pulmonary veins have a better
      outcomes for the progression of AF compared with patients undergoing isolated CABG.
This is a single blinded prospective randomized study involving 72 patients with paroxysmal
      AF and coronary artery disease. 72 patients are required to have a 80% chance of detecting,
      as significant at the 5% level, an increase in the primary outcome measure by 10% in the CABG
      + pulmonary veins isolation group over isolated CABG group. Patients are divided into two
      groups, group I - isolated CABG (36 patients), and group II - CABG and pulmonary veins
      isolation (36 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 pulmonary vein isolation. 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: Progression of atrial fibrillation
time frame: up to 36 months
description: Combined indicator consist of recurrence of AF, increased frequency of AF, progression to persistent AF.
Atrial fibrillation is defined as atrial fibrillation paroxysm lasting at least 60 seconds. Patients with AF>0.5% were classified as non-responders.
measure: Hospitalization due to atrial fibrillation after surgery
time frame: Within three years after surgery
description: All cases of hospitalization due to atrial fibrillation after surgery
measure: Cardiovascular events
time frame: Within three years after surgery
description: All cases of stroke, cardiac infarction, thromboembolism, bleeding and death
arm group label: CABG+pulmonary vein isolation
arm group type: Active Comparator
description: CABG+pulmonary vein isolation procedure
arm group label: Isolated CABG
arm group type: Active Comparator
description: Isolated CABG procedure
intervention type: Procedure
intervention name: CABG+Pulmonary vein isolation procedure
description: Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion. Concomitant pulmonary vein isolation in CBP prior to occlusion and CABG
arm group label: CABG+pulmonary vein isolation
intervention type: Procedure
intervention name: Isolated CABG
description: Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion.
arm group label: Isolated CABG
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Julia Kareva
phone: +79069952839
email: julia11108@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: Atrial Fibrillation
mesh term: Coronary Artery Disease