<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/NCT02238392</url>
  </required_header>
  <id_info>
    <org_study_id>1/2014</org_study_id>
    <nct_id>NCT02238392</nct_id>
  </id_info>
  <brief_title>Adenosine vs AF Termination for Paroxysmal AF Ablation</brief_title>
  <official_title>Arrhythmia Inducibility Versus Elimination of Dormant PV Conduction as a Procedural Endpoint of Catheter Ablation for Paroxysmal Atrial Fibrillation: a Prospective Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johannes Gutenberg University Mainz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johannes Gutenberg University Mainz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates impact of adenosine versus AF inducibility and subsequent termination&#xD;
      on the acute and long-term outcome of paroxysmal AF ablation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite intensive efforts to increase single procedure success rates of pulmonary vein&#xD;
      isolation (PVI) for paroxysmal atrial fibrillation (AF), an arrhythmia-free surveillance has&#xD;
      not raised beyond 80%. This prospective, randomized study investigates the efficacy of two&#xD;
      different procedural endpoints in terms of single-procedure arrhythmia-free outcome.&#xD;
&#xD;
      A total number of 152 patients undergoing de-novo catheter ablation for paroxysmal AF will be&#xD;
      randomized to two different treatment arms. In group-A patients, PVI will be performed with&#xD;
      the patient either in spontaneous or induced AF. If AF will not terminate with PVI, ablation&#xD;
      will be continued by targeting extra-PV AF sources with the desired endpoint of termination&#xD;
      to sinus rhythm (SR). The ablation procedure in group-B patients consists of PVI exclusively,&#xD;
      regardless to the underlying rhythm. In this group, all isolated PVs will be challenged to&#xD;
      adenosine administration in the attempt to reveal and ablate dormant conduction. The primary&#xD;
      endpoint is arrhythmia-free survival during a follow-up of 1 year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Arrhythmia-free survival</measure>
    <time_frame>1 year</time_frame>
    <description>arrhythmia-free outcome during 1 year after the procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence if PV conduction after ablation in PVs with abolished dormant conduction</measure>
    <time_frame>1 year</time_frame>
    <description>PV conduction recurrences after elimination of dormant conduction. This endpoint will be evaluated during repeat procedures for recurrences of atrial fibrillation or atrial tachycardia.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Paroxysmal Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Adenosine testing after PVI and elimination of dormant conduction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B - Termination of AF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Termination of atrial fibrillation by catheter ablation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Adenosine test</intervention_name>
    <description>Testing dormant conduction after PVI</description>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Termination of AF</intervention_name>
    <description>Testing AF iducibility and ermination of</description>
    <arm_group_label>Group B - Termination of AF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with paroxysmal AF&#xD;
&#xD;
          -  de-novo AF ablation&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  persistent AF&#xD;
&#xD;
          -  previous cardioversion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Rostock, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Mainz, Dept. of Cardiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Mainz, Department of Medicine II</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 10, 2014</last_update_submitted>
  <last_update_submitted_qc>September 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johannes Gutenberg University Mainz</investigator_affiliation>
    <investigator_full_name>Thomas Rostock</investigator_full_name>
    <investigator_title>Thomas Rostock, MD</investigator_title>
  </responsible_party>
  <keyword>paroxysmal atrial fibrillation</keyword>
  <keyword>pulmonary vein isolation</keyword>
  <keyword>adenosine</keyword>
  <keyword>AF terminatin</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>Adenosine</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/NCT02238392
org study id: 1/2014
nct id: NCT02238392
lead sponsor: 
has dmc: No
This study investigates impact of adenosine versus AF inducibility and subsequent termination
      on the acute and long-term outcome of paroxysmal AF ablation.
Despite intensive efforts to increase single procedure success rates of pulmonary vein
      isolation (PVI) for paroxysmal atrial fibrillation (AF), an arrhythmia-free surveillance has
      not raised beyond 80%. This prospective, randomized study investigates the efficacy of two
      different procedural endpoints in terms of single-procedure arrhythmia-free outcome.

      A total number of 152 patients undergoing de-novo catheter ablation for paroxysmal AF will be
      randomized to two different treatment arms. In group-A patients, PVI will be performed with
      the patient either in spontaneous or induced AF. If AF will not terminate with PVI, ablation
      will be continued by targeting extra-PV AF sources with the desired endpoint of termination
      to sinus rhythm (SR). The ablation procedure in group-B patients consists of PVI exclusively,
      regardless to the underlying rhythm. In this group, all isolated PVs will be challenged to
      adenosine administration in the attempt to reveal and ablate dormant conduction. The primary
      endpoint is arrhythmia-free survival during a follow-up of 1 year.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Arrhythmia-free survival
time frame: 1 year
description: arrhythmia-free outcome during 1 year after the procedure
measure: Recurrence if PV conduction after ablation in PVs with abolished dormant conduction
time frame: 1 year
description: PV conduction recurrences after elimination of dormant conduction. This endpoint will be evaluated during repeat procedures for recurrences of atrial fibrillation or atrial tachycardia.
arm group label: Group A
arm group type: Active Comparator
description: Adenosine testing after PVI and elimination of dormant conduction
arm group label: Group B - Termination of AF
arm group type: Active Comparator
description: Termination of atrial fibrillation by catheter ablation
intervention type: Procedure
intervention name: Adenosine test
description: Testing dormant conduction after PVI
arm group label: Group A
intervention type: Procedure
intervention name: Termination of AF
description: Testing AF iducibility and ermination of
arm group label: Group B - Termination of AF
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Rostock, MD
role: Principal Investigator
affiliation: University Hospital Mainz, Dept. of Cardiology
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Johannes Gutenberg University Mainz
investigator full name: Thomas Rostock
investigator title: Thomas Rostock, MD
mesh term: Atrial Fibrillation
mesh term: Adenosine