<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/NCT01661205</url>
  </required_header>
  <id_info>
    <org_study_id>CP2012-1</org_study_id>
    <nct_id>NCT01661205</nct_id>
  </id_info>
  <brief_title>Dual Epicardial Endocardial Persistent Atrial Fibrillation(AF) Study (Staged DEEP)</brief_title>
  <acronym>Staged DEEP</acronym>
  <official_title>Feasibility Trial of a Staged Epicardial &amp; Endocardial Approach for Treatment of Patients With Persistent or Long Standing Persistent Atrial Fibrillation With Radiofrequency Ablation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AtriCure, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AtriCure, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and technical feasibility of treating&#xD;
      subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation&#xD;
      in a minimally invasive thoracoscopic ablation procedure utilizing the AtriCure Bipolar&#xD;
      System, with mapping and additional lesion creation/ gap closure (as needed) provided by&#xD;
      currently approved catheter technology, when the epicardial and endocardial phases are&#xD;
      performed in a staged manner within 1-10 days apart, during the same hospitalization.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac&#xD;
      surgery using the AtriCure Bipolar System in conjunction with a catheter ablation procedure&#xD;
      performed approximately 1-10 days after, in treating atrial fibrillation, and how effective&#xD;
      is this staged procedure. The AtriCure Bipolar System will be used to perform the less&#xD;
      invasive cardiac surgery and a standard electrophysiology catheter, currently available, will&#xD;
      be used to perform the catheter ablation procedure. This surgical procedure is considered&#xD;
      less invasive because it is done through tiny surgical punctures on the sides of the chest&#xD;
      near the ribs instead of one large surgical incision of the breast bone to completely open&#xD;
      the chest and access the heart, and it also avoids the need for the heart-lung bypass&#xD;
      machine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer.</measure>
    <time_frame>30 days post-index procedure or hospital discharge</time_frame>
    <description>Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects With Absence of Atrial Fibrillation</measure>
    <time_frame>12 month follow-up</time_frame>
    <description>Absence of atrial fibrillation (AF) at twelve month follow-up based on continuous 14 day ECG monitoring, while off all Class I and III antiarrhythmic therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number Subjects With Serious Device or Procedure Related Adverse Event Rate</measure>
    <time_frame>12 month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Acute Procedure Success</measure>
    <time_frame>Day 0</time_frame>
    <description>Defined as subject meeting all of the following criteria upon completion of the index-EP procedure&#xD;
Isolation/block of all pulmonary veins (e.g. 4 of 4 veins);&#xD;
Bi-directional cavotricuspid isthmus block;&#xD;
Isolation of Box (i.e. no capture outside ablation lines connecting roof and floor lines between right-and-left pulmonary vein isolation lines);&#xD;
Superior Vena Cava (SVC) isolation, if encircling SVC lesion performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subject Without Atrial Fibrillation</measure>
    <time_frame>6 and 12 month follow-up</time_frame>
    <description>AF free with or without the need of antiarrhythmic drugs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Reinterventions</measure>
    <time_frame>12 month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Direct Current (DC) Cardioversion</measure>
    <time_frame>12 month follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores</measure>
    <time_frame>12 month follow-up</time_frame>
    <description>Change in Atrial Fibrillation Symptom Checklist Frequency and Severity Scores. This is reported as change from Baseline.&#xD;
This scale has 16 items to assess frequency of occurrence on a scale: Never; Rarely; Sometimes; Often; Always. These rating correspond to numerical values of: 1, 2, 3, 4, and 5, respectively. AF Frequency range from 0 to 80 . Higher scores indicating greater symptomatology.&#xD;
The same items are also used to assess severity on a scale: Mild; Moderate; Severe. Corresponding to 1, 2, and 3, respectively. AF Severity score range from 0 to 48. Higher scores indicating greater symptomatology.&#xD;
Negative change from baseline compared to 12-months represents an improvement in AF symptomatology .</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>AtriCure Bipolar System combined with a catheter ablation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ablation procedure staged catheter ablation</intervention_name>
    <description>AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart</description>
    <arm_group_label>AtriCure Bipolar System combined with a catheter ablation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 year&#xD;
&#xD;
          -  Patients with symptomatic persistent or longstanding persistent AF refractory to a&#xD;
             minimum of one Class I or III antiarrhythmic drug (AAD).&#xD;
&#xD;
          -  Patients with failed catheter ablation attempts are eligible if the patients are&#xD;
             symptomatic with persistent or longstanding persistent AF. (catheter ablation&#xD;
             procedure must be more than 3 months prior to index procedure)&#xD;
&#xD;
          -  Life expectancy of at least two years&#xD;
&#xD;
          -  Patient will and able to provide informed consent&#xD;
&#xD;
          -  Patient is willing and able to attend the scheduled follow-up visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior Cardiothoracic Surgery&#xD;
&#xD;
          -  Patient has NYHA (New York Heart Association) Class IV heart failure&#xD;
&#xD;
          -  Evidence of underlying structural heart disease requiring surgical treatment&#xD;
&#xD;
          -  Surgical procedure within the 30 days prior to the index procedure&#xD;
&#xD;
          -  Ejection fraction &lt; 30%&#xD;
&#xD;
          -  Measured left atrial diameter &gt; 6.0 cm&#xD;
&#xD;
          -  Renal Failure&#xD;
&#xD;
          -  Stroke within previous 6 months&#xD;
&#xD;
          -  Known carotid artery stenosis greater than 80%&#xD;
&#xD;
          -  Evidence of significant active infection or endocarditis&#xD;
&#xD;
          -  Pregnant woman or women desiring to become pregnant in the next 24 months&#xD;
&#xD;
          -  Presence of thrombus in the left atrium determined by echocardiography&#xD;
&#xD;
          -  History of blood dyscrasia&#xD;
&#xD;
          -  Contraindication to anticoagulation, based on Investigator's opinion&#xD;
&#xD;
          -  Mural thrombus or tumor&#xD;
&#xD;
          -  Moderate to Severe COPD&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stanford University Medical Center</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Springs Cardiology/Colorado Cardiac Alliance</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Heart Institute</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara Norfolk Hospital</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Brussel</name>
      <address>
        <city>Brussel</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academic Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Netherlands</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>July 11, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <results_first_submitted>February 7, 2017</results_first_submitted>
  <results_first_submitted_qc>April 7, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 17, 2017</results_first_posted>
  <last_update_submitted>April 7, 2017</last_update_submitted>
  <last_update_submitted_qc>April 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Persistent AF</keyword>
  <keyword>Longstanding Persistent AF</keyword>
  <keyword>Ablation</keyword>
  <keyword>catheter ablation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>First subject treated on September 11, 2012. A total of 31 subjects consented from 6 sites (4 USA and 2 Europe). One subject was exited from the study prior to intervention and was re-consented. Only 30 unique subjects were enrolled in the study. Twenty-six subjects treated from 5 sites.</recruitment_details>
      <pre_assignment_details>Five consented subjects were withdrew prior to treatment. Three did not meet the eligibility criteria, 1 subject was withdrawn by the investigator, and 1 subject withdrew consent.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>AtriCure Bipolar System Combined With a Catheter Ablation</title>
          <description>Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart&#xD;
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Number of Treated Subjects</population>
      <group_list>
        <group group_id="B1">
          <title>AtriCure Bipolar System Combined With a Catheter Ablation</title>
          <description>Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart&#xD;
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="26"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.7" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>inches</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71.0" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>Lbs.</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="220.9" spread="35.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.8" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer.</title>
        <description>Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms.</description>
        <time_frame>30 days post-index procedure or hospital discharge</time_frame>
        <population>Number of treated subjects. Although 26 subjects were anesthetized only 25 subjects underwent epicardial procedure per protocol. Physician decided not to treat one of the anesthetized subjects. Another case was aborted and converted to open chest cardioversion. Twenty-four patients underwent endocardial catheter procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>AtriCure Bipolar System Combined With a Catheter Ablation</title>
            <description>Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart&#xD;
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer.</title>
          <description>Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms.</description>
          <population>Number of treated subjects. Although 26 subjects were anesthetized only 25 subjects underwent epicardial procedure per protocol. Physician decided not to treat one of the anesthetized subjects. Another case was aborted and converted to open chest cardioversion. Twenty-four patients underwent endocardial catheter procedures.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects With Absence of Atrial Fibrillation</title>
        <description>Absence of atrial fibrillation (AF) at twelve month follow-up based on continuous 14 day ECG monitoring, while off all Class I and III antiarrhythmic therapy.</description>
        <time_frame>12 month follow-up</time_frame>
        <population>Subjects who are evaluable for primary efficacy endpoint, defined as all subjects in whom the minimally invasive staged epicardial/ endocardial ablation procedure is attempted and in whom the index-EP procedure and required post-procedure and 12 month follow-up efficacy endpoint assessment has been performed.</population>
        <group_list>
          <group group_id="O1">
            <title>AtriCure Bipolar System Combined With a Catheter Ablation</title>
            <description>Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart&#xD;
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Absence of Atrial Fibrillation</title>
          <description>Absence of atrial fibrillation (AF) at twelve month follow-up based on continuous 14 day ECG monitoring, while off all Class I and III antiarrhythmic therapy.</description>
          <population>Subjects who are evaluable for primary efficacy endpoint, defined as all subjects in whom the minimally invasive staged epicardial/ endocardial ablation procedure is attempted and in whom the index-EP procedure and required post-procedure and 12 month follow-up efficacy endpoint assessment has been performed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number Subjects With Serious Device or Procedure Related Adverse Event Rate</title>
        <time_frame>12 month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AtriCure Bipolar System Combined With a Catheter Ablation</title>
            <description>Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart&#xD;
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart</description>
          </group>
        </group_list>
        <measure>
          <title>Number Subjects With Serious Device or Procedure Related Adverse Event Rate</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Epicardial AF Procedure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Investigational Device</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Acute Procedure Success</title>
        <description>Defined as subject meeting all of the following criteria upon completion of the index-EP procedure&#xD;
Isolation/block of all pulmonary veins (e.g. 4 of 4 veins);&#xD;
Bi-directional cavotricuspid isthmus block;&#xD;
Isolation of Box (i.e. no capture outside ablation lines connecting roof and floor lines between right-and-left pulmonary vein isolation lines);&#xD;
Superior Vena Cava (SVC) isolation, if encircling SVC lesion performed.</description>
        <time_frame>Day 0</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AtriCure Bipolar System Combined With a Catheter Ablation</title>
            <description>Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart&#xD;
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Acute Procedure Success</title>
          <description>Defined as subject meeting all of the following criteria upon completion of the index-EP procedure&#xD;
Isolation/block of all pulmonary veins (e.g. 4 of 4 veins);&#xD;
Bi-directional cavotricuspid isthmus block;&#xD;
Isolation of Box (i.e. no capture outside ablation lines connecting roof and floor lines between right-and-left pulmonary vein isolation lines);&#xD;
Superior Vena Cava (SVC) isolation, if encircling SVC lesion performed.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subject Without Atrial Fibrillation</title>
        <description>AF free with or without the need of antiarrhythmic drugs</description>
        <time_frame>6 and 12 month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AtriCure Bipolar System Combined With a Catheter Ablation</title>
            <description>Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart&#xD;
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subject Without Atrial Fibrillation</title>
          <description>AF free with or without the need of antiarrhythmic drugs</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6-Months Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-Months Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Reinterventions</title>
        <time_frame>12 month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AtriCure Bipolar System Combined With a Catheter Ablation</title>
            <description>Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart&#xD;
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Reinterventions</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Direct Current (DC) Cardioversion</title>
        <time_frame>12 month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AtriCure Bipolar System Combined With a Catheter Ablation</title>
            <description>Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart&#xD;
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Direct Current (DC) Cardioversion</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores</title>
        <description>Change in Atrial Fibrillation Symptom Checklist Frequency and Severity Scores. This is reported as change from Baseline.&#xD;
This scale has 16 items to assess frequency of occurrence on a scale: Never; Rarely; Sometimes; Often; Always. These rating correspond to numerical values of: 1, 2, 3, 4, and 5, respectively. AF Frequency range from 0 to 80 . Higher scores indicating greater symptomatology.&#xD;
The same items are also used to assess severity on a scale: Mild; Moderate; Severe. Corresponding to 1, 2, and 3, respectively. AF Severity score range from 0 to 48. Higher scores indicating greater symptomatology.&#xD;
Negative change from baseline compared to 12-months represents an improvement in AF symptomatology .</description>
        <time_frame>12 month follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>AtriCure Bipolar System Combined With a Catheter Ablation</title>
            <description>Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart&#xD;
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart</description>
          </group>
        </group_list>
        <measure>
          <title>Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores</title>
          <description>Change in Atrial Fibrillation Symptom Checklist Frequency and Severity Scores. This is reported as change from Baseline.&#xD;
This scale has 16 items to assess frequency of occurrence on a scale: Never; Rarely; Sometimes; Often; Always. These rating correspond to numerical values of: 1, 2, 3, 4, and 5, respectively. AF Frequency range from 0 to 80 . Higher scores indicating greater symptomatology.&#xD;
The same items are also used to assess severity on a scale: Mild; Moderate; Severe. Corresponding to 1, 2, and 3, respectively. AF Severity score range from 0 to 48. Higher scores indicating greater symptomatology.&#xD;
Negative change from baseline compared to 12-months represents an improvement in AF symptomatology .</description>
          <units>percentage of from baseline</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Checklist Frequency Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.3" spread="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Checklist Severity Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.6" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24-months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>AtriCure Bipolar System Combined With a Catheter Ablation</title>
          <description>Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart&#xD;
Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 12.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Atrial tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Cardiac tamponade</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Multi-organ failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Device lead damage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Procedural hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc degeneration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Convulsion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Unresponsive to stimuli</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Vocal cord paralysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Diaphragmatic paralysis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Ankle operation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Heart valve operation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 12.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diaphragmatic paralysis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Vice President, Clinical Operations</name_or_title>
      <organization>AtriCure, Inc.</organization>
      <phone>513-755-4562</phone>
      <email>SZink@AtriCure.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01661205
org study id: CP2012-1
nct id: NCT01661205
lead sponsor: 
has dmc: Yes
The purpose of this study is to assess the safety and technical feasibility of treating
      subjects with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation
      in a minimally invasive thoracoscopic ablation procedure utilizing the AtriCure Bipolar
      System, with mapping and additional lesion creation/ gap closure (as needed) provided by
      currently approved catheter technology, when the epicardial and endocardial phases are
      performed in a staged manner within 1-10 days apart, during the same hospitalization.
The purpose of this clinical investigation is to evaluate how safe a less invasive cardiac
      surgery using the AtriCure Bipolar System in conjunction with a catheter ablation procedure
      performed approximately 1-10 days after, in treating atrial fibrillation, and how effective
      is this staged procedure. The AtriCure Bipolar System will be used to perform the less
      invasive cardiac surgery and a standard electrophysiology catheter, currently available, will
      be used to perform the catheter ablation procedure. This surgical procedure is considered
      less invasive because it is done through tiny surgical punctures on the sides of the chest
      near the ribs instead of one large surgical incision of the breast bone to completely open
      the chest and access the heart, and it also avoids the need for the heart-lung bypass
      machine.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Patients With Pre-specified Safety Endpoints Occurring in the First 30 Days Post-index Procedure or Hospital Discharge, Whichever is Longer.
time frame: 30 days post-index procedure or hospital discharge
description: Pre-specified events include: Death; Myocardial Infarction; Stroke or TIA; Excess bleeding; Pulmonary vein stenosis; atrio-esophagael fistula; phrenic nerve paralysis; Pericardial effusion; Embolisms.
measure: Number of Subjects With Absence of Atrial Fibrillation
time frame: 12 month follow-up
description: Absence of atrial fibrillation (AF) at twelve month follow-up based on continuous 14 day ECG monitoring, while off all Class I and III antiarrhythmic therapy.
measure: Number Subjects With Serious Device or Procedure Related Adverse Event Rate
time frame: 12 month follow-up
measure: Number of Subjects With Acute Procedure Success
time frame: Day 0
description: Defined as subject meeting all of the following criteria upon completion of the index-EP procedure
Isolation/block of all pulmonary veins (e.g. 4 of 4 veins);
Bi-directional cavotricuspid isthmus block;
Isolation of Box (i.e. no capture outside ablation lines connecting roof and floor lines between right-and-left pulmonary vein isolation lines);
Superior Vena Cava (SVC) isolation, if encircling SVC lesion performed.
measure: Number of Subject Without Atrial Fibrillation
time frame: 6 and 12 month follow-up
description: AF free with or without the need of antiarrhythmic drugs
measure: Number of Subjects With Reinterventions
time frame: 12 month follow-up
measure: Number of Subjects With Direct Current (DC) Cardioversion
time frame: 12 month follow-up
measure: Change in AF Based on AF Symptoms Checklist Frequency and Severity Scores
time frame: 12 month follow-up
description: Change in Atrial Fibrillation Symptom Checklist Frequency and Severity Scores. This is reported as change from Baseline.
This scale has 16 items to assess frequency of occurrence on a scale: Never; Rarely; Sometimes; Often; Always. These rating correspond to numerical values of: 1, 2, 3, 4, and 5, respectively. AF Frequency range from 0 to 80 . Higher scores indicating greater symptomatology.
The same items are also used to assess severity on a scale: Mild; Moderate; Severe. Corresponding to 1, 2, and 3, respectively. AF Severity score range from 0 to 48. Higher scores indicating greater symptomatology.
Negative change from baseline compared to 12-months represents an improvement in AF symptomatology .
arm group label: AtriCure Bipolar System combined with a catheter ablation
arm group type: Experimental
description: Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart
intervention type: Device
intervention name: Ablation procedure staged catheter ablation
description: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart
arm group label: AtriCure Bipolar System combined with a catheter ablation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Netherlands
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 