<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/NCT01709682</url>
  </required_header>
  <id_info>
    <org_study_id>PAF-DT-RA</org_study_id>
    <nct_id>NCT01709682</nct_id>
  </id_info>
  <brief_title>A Comparison of the Drug Therapy Versus Re-Ablation</brief_title>
  <official_title>Progression of Atrial Fibrillation After a Failed Initial Ablation Procedure in Patients With Paroxysmal Atrial Fibrillation: A Randomized Comparison of the Drug Therapy Versus Re-Ablation</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 hypothesis of this study was that early re-ablation (test) was superior to AAD therapy&#xD;
      (control) in patients with previous failed PVI ablation for paroxysmal AF.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2007</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">January 2012</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>progression of AF (AF burden progression and persistent AF)</measure>
    <time_frame>3 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>recurrence of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of further ablation</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>predictors of AF progression</measure>
    <time_frame>3 years</time_frame>
    <description>AF burden by ILR monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complications</measure>
    <time_frame>3 years</time_frame>
    <description>tamponade&#xD;
pulmonary vein stenosis&#xD;
atrio-esophora fistula (for re-ablation arm)&#xD;
ventricular arrhythmia&#xD;
symptomatic bradycardia (for AAD arm)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">154</enrollment>
  <condition>Paroxysmal Atrial Fibrillation</condition>
  <condition>Failed First Radiofrequency Ablation Procedure</condition>
  <arm_group>
    <arm_group_label>AAD therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Recurrent episodes were pharmacologically managed by conventional AAD therapy (propafenone, flecainide, and/or sotalol as first-line drugs in patients without structural heart disease or amiodarone as a single drug or in combination in patients with structural heart disease or in case of first-line drug failure) according to AF management guidelines.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>re-ablation procedure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Reisolation of the PVs was performed by identifying the breakthrough site on the mapping catheter (NaviStar ThermoCool, Biosense-Webster Inc., Diamond Bar, CA). RF energy was delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation rate of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by &gt;80% or RF energy deliveries exceeded 40 s.&#xD;
The endpoint of ablation was complete PVI; this was confirmed when Lasso catheter mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from LA activity. Only in patients with induced left atrial flutter, additional RF ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the roof of the LA between the two superior PVs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anti-Arrhythmia Agents (propafenone, flecainide, and/or sotalol, or amiodarone)</intervention_name>
    <description>propafenone, flecainide, and/or sotalol as first-line drugs in patients without structural heart disease or amiodarone as a single drug or in combination in patients with structural heart disease or in case of first-line drug failure</description>
    <arm_group_label>AAD therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>re-ablation procedure</intervention_name>
    <description>Reisolation of the PVs was performed by identifying the breakthrough site on the mapping catheter (NaviStar ThermoCool, Biosense-Webster Inc., Diamond Bar, CA). RF energy was delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation rate of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by &gt;80% or RF energy deliveries exceeded 40 s. The endpoint of ablation was complete PVI; this was confirmed when Lasso catheter mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from LA activity.</description>
    <arm_group_label>re-ablation procedure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ILR implantation</intervention_name>
    <description>The Reveal XT was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check.&#xD;
Patients were provided with the Patient Assistant, a tool that allows each patient to store the ECG through the implanted device during symptoms; data were collected in order to analyze heart rhythm during symptomatic events.</description>
    <arm_group_label>AAD therapy</arm_group_label>
    <arm_group_label>re-ablation procedure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  history of symptomatic PAF&#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 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>October 16, 2012</last_update_submitted>
  <last_update_submitted_qc>October 16, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>atrial fibrillation</keyword>
  <keyword>arrhythmias</keyword>
  <keyword>anti-arrhythmic agents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amiodarone</mesh_term>
    <mesh_term>Sotalol</mesh_term>
    <mesh_term>Flecainide</mesh_term>
    <mesh_term>Propafenone</mesh_term>
    <mesh_term>Anti-Arrhythmia Agents</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/NCT01709682
org study id: PAF-DT-RA
nct id: NCT01709682
lead sponsor: 
has dmc: No
The hypothesis of this study was that early re-ablation (test) was superior to AAD therapy
      (control) in patients with previous failed PVI ablation for paroxysmal AF.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: progression of AF (AF burden progression and persistent AF)
time frame: 3 year
measure: recurrence of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia
time frame: 3 years
measure: number of further ablation
time frame: 3 years
measure: predictors of AF progression
time frame: 3 years
description: AF burden by ILR monitoring
measure: complications
time frame: 3 years
description: tamponade
pulmonary vein stenosis
atrio-esophora fistula (for re-ablation arm)
ventricular arrhythmia
symptomatic bradycardia (for AAD arm)
arm group label: AAD therapy
arm group type: Active Comparator
description: Recurrent episodes were pharmacologically managed by conventional AAD therapy (propafenone, flecainide, and/or sotalol as first-line drugs in patients without structural heart disease or amiodarone as a single drug or in combination in patients with structural heart disease or in case of first-line drug failure) according to AF management guidelines.
arm group label: re-ablation procedure
arm group type: Active Comparator
description: Reisolation of the PVs was performed by identifying the breakthrough site on the mapping catheter (NaviStar ThermoCool, Biosense-Webster Inc., Diamond Bar, CA). RF energy was delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation rate of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 s.
The endpoint of ablation was complete PVI; this was confirmed when Lasso catheter mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from LA activity. Only in patients with induced left atrial flutter, additional RF ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the roof of the LA between the two superior PVs.
intervention type: Drug
intervention name: Anti-Arrhythmia Agents (propafenone, flecainide, and/or sotalol, or amiodarone)
description: propafenone, flecainide, and/or sotalol as first-line drugs in patients without structural heart disease or amiodarone as a single drug or in combination in patients with structural heart disease or in case of first-line drug failure
arm group label: AAD therapy
intervention type: Procedure
intervention name: re-ablation procedure
description: Reisolation of the PVs was performed by identifying the breakthrough site on the mapping catheter (NaviStar ThermoCool, Biosense-Webster Inc., Diamond Bar, CA). RF energy was delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation rate of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 s. The endpoint of ablation was complete PVI; this was confirmed when Lasso catheter mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from LA activity.
arm group label: re-ablation procedure
intervention type: Procedure
intervention name: ILR implantation
description: The Reveal XT was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check.
Patients were provided with the Patient Assistant, a tool that allows each patient to store the ECG through the implanted device during symptoms; data were collected in order to analyze heart rhythm during symptomatic events.
arm group label: AAD therapy
arm group label: re-ablation procedure
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
mesh term: Amiodarone
mesh term: Sotalol
mesh term: Flecainide
mesh term: Propafenone
mesh term: Anti-Arrhythmia Agents