<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/NCT01724437</url>
  </required_header>
  <id_info>
    <org_study_id>PV3503</org_study_id>
    <nct_id>NCT01724437</nct_id>
  </id_info>
  <brief_title>Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation</brief_title>
  <official_title>Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsklinikum Hamburg-Eppendorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsklinikum Hamburg-Eppendorf</source>
  <brief_summary>
    <textblock>
      to assess the near-term (12 months) efficacy of pulmonary vein isolation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study was to assess the near-term (12 months) efficacy of pulmonary vein&#xD;
      isolation using a standard approach compared to application of an additional acute procedural&#xD;
      endpoint of unexcitability along the ablation line.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2009</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2010</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>
    <masking_description>Open Label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>time to AF and AT recurrence</measure>
    <time_frame>12 months</time_frame>
    <description>recurrence of AF as assessed by 3 day holter monitoring, assessment of AT recurrence using 3 day holter monitoring</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>procedure duration</measure>
    <time_frame>completed (15 months)</time_frame>
    <description>time needed to complete the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>procedure safety</measure>
    <time_frame>up to three days after the procedure</time_frame>
    <description>complication such as groin hematoma, stroke and pericardial bleed prolonging the hospital stay will be assessed</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Paroxysmal Atrial Fibrillation</condition>
  <condition>Catheter Ablation Strategies</condition>
  <arm_group>
    <arm_group_label>Loss of pace capture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pulmonary vein isolation: Ablation along the ablation line is continued until loss of pace capture along the ablation line is achieved&#xD;
catheter based pulmonary vein isolation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pulmonary vein isolation: Ablation is discontinued when electrical isolation of the pulmonary veins is achieved.&#xD;
catheter based pulmonary vein isolation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>catheter based pulmonary vein isolation</intervention_name>
    <description>catheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice</description>
    <arm_group_label>Conventional</arm_group_label>
    <arm_group_label>Loss of pace capture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  paroxysmal atrial fibrillation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  structural heart disease&#xD;
&#xD;
          -  intracardiac thrombus&#xD;
&#xD;
          -  reversible causes of atrial fibrillation&#xD;
&#xD;
          -  inability to take warfarin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephan Willems</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitäres Herzzentrum Hamburg GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Hamburg</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 4, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>August 27, 2022</last_update_submitted>
  <last_update_submitted_qc>August 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT01724437
org study id: PV3503
nct id: NCT01724437
lead sponsor: 
to assess the near-term (12 months) efficacy of pulmonary vein isolation.
The aim of the study was to assess the near-term (12 months) efficacy of pulmonary vein
      isolation using a standard approach compared to application of an additional acute procedural
      endpoint of unexcitability along the ablation line.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Open Label
measure: time to AF and AT recurrence
time frame: 12 months
description: recurrence of AF as assessed by 3 day holter monitoring, assessment of AT recurrence using 3 day holter monitoring
measure: procedure duration
time frame: completed (15 months)
description: time needed to complete the procedure
measure: procedure safety
time frame: up to three days after the procedure
description: complication such as groin hematoma, stroke and pericardial bleed prolonging the hospital stay will be assessed
arm group label: Loss of pace capture
arm group type: Active Comparator
description: Pulmonary vein isolation: Ablation along the ablation line is continued until loss of pace capture along the ablation line is achieved
catheter based pulmonary vein isolation
arm group label: Conventional
arm group type: Active Comparator
description: Pulmonary vein isolation: Ablation is discontinued when electrical isolation of the pulmonary veins is achieved.
catheter based pulmonary vein isolation
intervention type: Device
intervention name: catheter based pulmonary vein isolation
description: catheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice
arm group label: Conventional
arm group label: Loss of pace capture
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stephan Willems
role: Principal Investigator
affiliation: Universitäres Herzzentrum Hamburg GmbH
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Atrial Fibrillation