<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/NCT02234102</url>
  </required_header>
  <id_info>
    <org_study_id>AF 34/2014 version 02</org_study_id>
    <nct_id>NCT02234102</nct_id>
  </id_info>
  <brief_title>Eagle AF (Atrial Fibrillation) - Endoscopically Guided Laser Ablation of Persistent Atrial Fibrillation</brief_title>
  <official_title>Eagle AF - Endoscopically Guided Laser Ablation of Persistent Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Dr. med. Bernd Lemke</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Märkische Kliniken GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to compare the results of pulmonary vein isolation (PVI) with a single&#xD;
      technology approach in patients suffering from paroxysmal atrial fibrillation (PAF) with&#xD;
      patients who have persistent AF of less than 3 months. Many studies have shown that&#xD;
      electrical reconnection of the pulmonary veins following the index procedure can occur in up&#xD;
      to 40% of targeted veins leading to a recurrence of PAF. Endoscopically guided laser ablation&#xD;
      utilising the HeartLight system (CardioFocus Inc., USA) has been shown to be safe and&#xD;
      effective and has also shown promising rates of durable isolation compared to point by point&#xD;
      radio frequency techniques. However, the impact of employing this technique for patients with&#xD;
      persistent AF has not yet been reported. The study hypothesis is that there will be no&#xD;
      statistically significant difference between the results of PVI in the two groups of&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Documented recurrence of AF or any tachyarrhythmia lasting &gt; 30 seconds</measure>
    <time_frame>Between day 90 and 365 after index procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of electrical cardioversions needed</measure>
    <time_frame>365 days after index procedure</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Persistent Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Paroxysmal Atrial Fibrillation (PAF)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endoscopically guided laser ablation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Persistent Atrial Fibrillation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endoscopically guided laser ablation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endoscopically guided laser ablation HeartLight system</intervention_name>
    <arm_group_label>Paroxysmal Atrial Fibrillation (PAF)</arm_group_label>
    <arm_group_label>Persistent Atrial Fibrillation</arm_group_label>
    <other_name>HeartLight system</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  failure of at least one specific class I or III antiarrhythmic drug (AAD)&#xD;
&#xD;
          -  left atrial size &lt; 50 mm&#xD;
&#xD;
          -  left ventricular ejection fraction &gt; 45%&#xD;
&#xD;
          -  others&#xD;
&#xD;
          -  specific for PAF: diagnosed with self-terminating episodes for no longer than 7 days&#xD;
&#xD;
          -  specific for persistent AF: diagnosed with episodes of &gt; 7 days and &lt; 90 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  AF secondary to a reversible cause of non-cardiac origin&#xD;
&#xD;
          -  uncontrollable hypertension&#xD;
&#xD;
          -  left atrial thrombus&#xD;
&#xD;
          -  others&#xD;
&#xD;
          -  specific for PAF: more than 1 electrical cardioversion in the year prior to enrollment&#xD;
&#xD;
          -  specific for persistent AF more than 4 electrical cardioversions in the year prior to&#xD;
             enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bernd Lemke, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinikum Lüdenscheid Klinik f. Innere Medizin III</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bernd Lemke, Prof. Dr.</last_name>
    <phone>+49 2351 4665551</phone>
    <email>Bernd.Lemke@klinikum-luedenscheid.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Markus Zarse, PD Dr.</last_name>
    <phone>+49 2351 4666299</phone>
    <email>Markus.Zarse@klinikum-luedenscheid.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>St.Vinzenz-Hospital GmbH</name>
      <address>
        <city>Köln</city>
        <state>NRW</state>
        <zip>50733</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dinh Quang Nguyen, Dr.</last_name>
      <phone>+49 22177124059</phone>
      <email>DinhQuang.Nguyen@cellitinnen.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Märkische Kliniken GmbH, Klinik für Innere Medizin III</name>
      <address>
        <city>Lüdenscheid</city>
        <state>NRW</state>
        <zip>58515</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Markus Zarse, PD Dr.</last_name>
      <phone>+49 2351 4666299</phone>
      <email>Markus.Zarse@klinikum-luedenscheid.de</email>
    </contact>
    <investigator>
      <last_name>Markus Zarse, PD Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vivantes Netzwerk für Gesundheit GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>13407</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Niels Christian Ewertsen, Dr.</last_name>
      <phone>+49 30130225167</phone>
      <email>Niels-Christian.Ewertsen@vivantes.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>August 20, 2015</last_update_submitted>
  <last_update_submitted_qc>August 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Märkische Kliniken GmbH</investigator_affiliation>
    <investigator_full_name>Prof. Dr. med. Bernd Lemke</investigator_full_name>
    <investigator_title>Klinikdirektor der Klinik für Innere Medizin III</investigator_title>
  </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/NCT02234102
org study id: AF 34/2014 version 02
nct id: NCT02234102
lead sponsor: 
has dmc: No
The study aims to compare the results of pulmonary vein isolation (PVI) with a single
      technology approach in patients suffering from paroxysmal atrial fibrillation (PAF) with
      patients who have persistent AF of less than 3 months. Many studies have shown that
      electrical reconnection of the pulmonary veins following the index procedure can occur in up
      to 40% of targeted veins leading to a recurrence of PAF. Endoscopically guided laser ablation
      utilising the HeartLight system (CardioFocus Inc., USA) has been shown to be safe and
      effective and has also shown promising rates of durable isolation compared to point by point
      radio frequency techniques. However, the impact of employing this technique for patients with
      persistent AF has not yet been reported. The study hypothesis is that there will be no
      statistically significant difference between the results of PVI in the two groups of
      patients.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Documented recurrence of AF or any tachyarrhythmia lasting > 30 seconds
time frame: Between day 90 and 365 after index procedure
measure: Number of electrical cardioversions needed
time frame: 365 days after index procedure
arm group label: Paroxysmal Atrial Fibrillation (PAF)
arm group type: Active Comparator
description: Endoscopically guided laser ablation
arm group label: Persistent Atrial Fibrillation
arm group type: Active Comparator
description: Endoscopically guided laser ablation
intervention type: Device
intervention name: Endoscopically guided laser ablation HeartLight system
arm group label: Paroxysmal Atrial Fibrillation (PAF)
arm group label: Persistent Atrial Fibrillation
other name: HeartLight system
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Bernd Lemke, Prof. Dr.
role: Principal Investigator
affiliation: Klinikum Lüdenscheid Klinik f. Innere Medizin III
last name: Bernd Lemke, Prof. Dr.
phone: +49 2351 4665551
email: Bernd.Lemke@klinikum-luedenscheid.de
last name: Markus Zarse, PD Dr.
phone: +49 2351 4666299
email: Markus.Zarse@klinikum-luedenscheid.de
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: Märkische Kliniken GmbH
investigator full name: Prof. Dr. med. Bernd Lemke
investigator title: Klinikdirektor der Klinik für Innere Medizin III
mesh term: Atrial Fibrillation