<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/NCT02982434</url>
  </required_header>
  <id_info>
    <org_study_id>RSTD_021216</org_study_id>
    <nct_id>NCT02982434</nct_id>
  </id_info>
  <brief_title>The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation</brief_title>
  <official_title>Injection of the New Pharmaceutical Composition Containing Botulinum Toxin Into Epicardial Fat Pads to Treat Atrial Fibrillation After 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 double-blind study was to compare the efficacy of new&#xD;
      pharmaceutical composition containing botulinum toxin injection in epicardial fat pads for&#xD;
      preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial&#xD;
      fibrillation undergoing coronary artery bypass grafting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Freedom from any atrial tachyarrhythmias</measure>
    <time_frame>12 months</time_frame>
    <description>Recurrence of &gt;30 s of any atrial tachyarrhythmia, including atrial fibrillation and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of deaths</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU</measure>
    <time_frame>1 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>stroke or transient ischemic attack</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of myocardial infarction</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rehospitalization</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</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>All patients underwent conventional CABG surgery. After the main stage of the surgery new pharmaceutical composition containing botulinum toxin (50 U/1 mL) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right ganglionated plexi (GP); second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior pulmonary vein (PV) and left inferior PV (between the PVs and left atrial appendage (LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All patients underwent conventional cardiac surgery. After the main stage of the surgery 0.9% normal saline (1 mL at each fat pad) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right GP; second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior PV and left inferior PV (between the PVs and LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pharmaceutical composition containing botulinum toxin</intervention_name>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.9% normal saline</intervention_name>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <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>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with paroxysmal AF (recurrent episodes for at least 2 years, with ≥ 6&#xD;
             episodes over the last 6 months)&#xD;
&#xD;
          -  At least one failed antiarrhythmic drug&#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 or atrial&#xD;
        fibrillation at the time of screening Planned maze procedure or pulmonary vein isolation&#xD;
        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>
    <email>E.Pokushalov@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>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>Alexander Romanov, MD, PhD</last_name>
      <phone>+73833327655</phone>
      <email>abromanov@mail.ru</email>
    </contact>
    <contact_backup>
      <last_name>Evgeny Pokushalov, MD, PhD</last_name>
      <phone>+73833327655</phone>
      <email>E.Pokushalov@gmail.com</email>
    </contact_backup>
  </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</last_name>
      <phone>7(3822) 55 35 96</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 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>atrial fibrillation</keyword>
  <keyword>botulinum toxin</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins</mesh_term>
  </intervention_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/NCT02982434
org study id: RSTD_021216
nct id: NCT02982434
lead sponsor: 
The aim of this prospective randomized double-blind study was to compare the efficacy of new
      pharmaceutical composition containing botulinum toxin injection in 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, Investigator)
measure: Freedom from any atrial tachyarrhythmias
time frame: 12 months
description: Recurrence of >30 s of any atrial tachyarrhythmia, including atrial fibrillation and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug
measure: number of deaths
time frame: 12 month
measure: time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU
time frame: 1 month
measure: incidence of congestive heart failure
time frame: 12 month
measure: incidence of sustained ventricular arrhythmias
time frame: 12 month
measure: stroke or transient ischemic attack
time frame: 12 month
measure: incidence of myocardial infarction
time frame: 12 month
measure: rehospitalization
time frame: 12 months
arm group label: Group 1
arm group type: Experimental
description: All patients underwent conventional CABG surgery. After the main stage of the surgery new pharmaceutical composition containing botulinum toxin (50 U/1 mL) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right ganglionated plexi (GP); second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior pulmonary vein (PV) and left inferior PV (between the PVs and left atrial appendage (LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP
arm group label: Group 2
arm group type: Active Comparator
description: All patients underwent conventional cardiac surgery. After the main stage of the surgery 0.9% normal saline (1 mL at each fat pad) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right GP; second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior PV and left inferior PV (between the PVs and LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP
intervention type: Drug
intervention name: Pharmaceutical composition containing botulinum toxin
arm group label: Group 1
intervention type: Drug
intervention name: 0.9% normal saline
arm group label: Group 2
intervention type: Procedure
intervention name: Coronary artery bypass grafting
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
email: E.Pokushalov@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
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
mesh term: Botulinum Toxins