<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/NCT01694563</url>
  </required_header>
  <id_info>
    <org_study_id>CP2011-1</org_study_id>
    <nct_id>NCT01694563</nct_id>
    <nct_alias>NCT01174745</nct_alias>
  </id_info>
  <brief_title>ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation</brief_title>
  <acronym>ABLATE-PAS</acronym>
  <official_title>AtriCure Synergy Ablation Lesions for Non-Paroxysmal Forms of Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this post-approval study is to evaluate the clinical outcomes in a&#xD;
      cohort of patients with non-paroxysmal forms of atrial fibrillation (persistent or&#xD;
      long-standing persistent) treated during commercial use of the AtriCure Synergy Ablation&#xD;
      System by physicians performed the Maze IV procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective, open label, multi-center, observational, single arm registry is designed to&#xD;
      monitor the AtriCure Synergy Ablation System continued safety and efficacy during the&#xD;
      peri-procedural and long-term phase during commercial use in patients being treated for&#xD;
      non-paroxysmal forms of atrial fibrillation who are undergoing a concomitant open, on-pump&#xD;
      cardiac surgical procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Actual">March 21, 2018</completion_date>
  <primary_completion_date type="Actual">October 23, 2017</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>
    <masking_description>open label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The Number of Participants Free From Atrial Fibrillation (AF), Atrial Flutter or Atrial Tachycardia While Off Class I and Class III Antiarrhythmic Drugs for at Least 4 Weeks.</measure>
    <time_frame>36 months post-operatively</time_frame>
    <description>The number of participants free from atrial fibrillation (AF), i.e., episodes lasting &gt;30 continuous seconds duration of either AF, atrial flutter or atrial tachycardia while off Class I and III antiarrythmic drugs for at least 4 weeks as determined by core last assessment of a 48 hour Holter, Zio Patch or Pacemaker Implantation (PPM) interrogation recording performed at a minimum of 36 months postoperatively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Outcome</measure>
    <time_frame>12, 24, and 36 months post-operatively</time_frame>
    <description>The proportion of patients free from AF, regardless of AAD usage (i.e. no episodes lasting &gt; 30 continuous seconds duration of either Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia), as determined by an independent core lab assessment of 48-hour Holter, Zio™ Patch or PPM interrogation recording performed at a minimum of 12,24, and 36 months post-operatively.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">365</enrollment>
  <condition>Persistent Atrial Fibrillation</condition>
  <condition>Longstanding Persistent Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Atrial Fibrillation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients with non-paroxysmal atrial fibrillation (persistent or longstanding persistent)who are scheduled to undergo elective concomitant open, on-pump cardiac surgical procedure and the Maze IV ablation procedure. This single arm registry is designed to monitor the AtriCure Synergy Ablation System for continued safety and efficacy during the peri-procedural and long term phase during commercial use.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Synergy Ablation System</intervention_name>
    <description>Patient will undergo an elective open cardiac surgical procedure to be performed on cardiopulmonary bypass for one or more of the following:&#xD;
Coronary Artery Bypass Grafting (CABG)&#xD;
Mitral valve repair or replacement&#xD;
Aortic valve repair or replacement&#xD;
Tricuspid valve repair or replacement The aim of the treatment is a complete bi-atrial Maze IV procedure which includes pulmonary vein isolation coupled with lesions made on both the left and right atria.</description>
    <arm_group_label>Atrial Fibrillation</arm_group_label>
    <other_name>Isolator Synergy Handpieces</other_name>
    <other_name>Isolator Synergy Clamp</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; or equal to 18 years of age&#xD;
&#xD;
          -  History of non-paroxysmal form of Atrial Fibrillation (AF) as defined by the Heart&#xD;
             Rhythm Society/European Heart Rhythm Association/European Cardiac Arrhythmia Society&#xD;
             Consensus Statement:&#xD;
&#xD;
               -  Persistent AF shall be defined as continuous AF that is sustained beyond seven&#xD;
                  days. Episodes of AF in which a decision is made to electrically or&#xD;
                  pharmacologically cardiovert the patient after greater than or equal to 48 hours&#xD;
                  of AF but prior to 7 days, should also be classified as persistent AF episodes.&#xD;
&#xD;
               -  Longstanding persistent AF shall be defined as continuous AF of greater than 12&#xD;
                  months duration. The performance of a successful cardioversion (sinus rhythm &gt;30&#xD;
                  seconds) within 12 months of an ablation procedure with documented early&#xD;
                  recurrence of AF with 30 days should not alter the classification of AF as&#xD;
                  longstanding persistent.&#xD;
&#xD;
          -  Subject is scheduled to undergo elective open cardiac surgical procedure(s) to be&#xD;
             performed on cardiopulmonary bypass for one or more of the following: Coronary Artery&#xD;
             Bypass Grafting, Mitral valve repair or replacement, Aortic valve repair or&#xD;
             replacement, Tricuspid valve repair or replacement. In conjunction with these&#xD;
             procedure patent foramen ovale (PFO) or atrial septal defect (ASD) repair are allowed.&#xD;
&#xD;
          -  The patient (or their legally authorized representative) agrees to participate in this&#xD;
             study by singing the Institutional Review Board (IRB) approved informed consent form.&#xD;
&#xD;
          -  Willing and able to return for scheduled follow up visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stand along AF without indication(s) for concomitant cardiac surgery.&#xD;
&#xD;
          -  Need for emergent cardiac surgery (i.e., cardiogenic shock).&#xD;
&#xD;
          -  Preoperative need for an intra-aortic balloon pump or intravenous inotropes.&#xD;
&#xD;
          -  Pregnancy or desire to get pregnant for the duration of the study concomitant surgical&#xD;
             procedure through the thirty six (36) month follow up period).&#xD;
&#xD;
          -  Enrolled in another clinical trial that could confound the results of this study.&#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>Patrick McCarthy, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Chief, Division of Cardiac Surgery, Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama-Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scottsdale Healthcare Clinical Research Institute</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC University Hospital</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ronald Reagan UCLA Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sharp Memorial Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>West Hollywood</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hartford Hospital</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lee Memorial Hospital</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida Cardiothoracic Surgery</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bayfront Medical Center</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Hospital</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33709</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James A. Haley Veteran's Hospital/Cardiothoracic Surgery</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pepin Heart Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Memorial Hospital</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SIU- Memorial Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Francis Heart Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inidiana Heart Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46290</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Maine</state>
        <zip>04102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veteran Affairs Boston Healthcare System</name>
      <address>
        <city>West Roxbury</city>
        <state>Massachusetts</state>
        <zip>02132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum Health</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sparrow Clinical Research Institute</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Beaumont Hospital</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Munson Medical Center</name>
      <address>
        <city>Traverse City</city>
        <state>Michigan</state>
        <zip>49684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United Heart &amp; Vascular/Abbott Northwestern Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Missouri Baptist Medical Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Heart</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Regional Medical Center</name>
      <address>
        <city>Paterson</city>
        <state>New Jersey</state>
        <zip>07503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mission Hospital/Asheville Heart</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Medical Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Triad Cardiac and Thoracic Surgeons/Cone Health</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altru Health System</name>
      <address>
        <city>Grand Forks</city>
        <state>North Dakota</state>
        <zip>58201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Good Samaritan Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals of Cleveland</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toledo Hospital</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Heart Hospital</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pinnacle Health Hospitals</name>
      <address>
        <city>Harrisburg</city>
        <state>Pennsylvania</state>
        <zip>17101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania (HUP)</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny General Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Memorial Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern University Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mark's Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara Norfolk General Hospital</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aspirus Wausau Hospital</name>
      <address>
        <city>Wausau</city>
        <state>Wisconsin</state>
        <zip>54401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <results_first_submitted>October 29, 2018</results_first_submitted>
  <results_first_submitted_qc>September 12, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 13, 2019</results_first_posted>
  <last_update_submitted>September 25, 2019</last_update_submitted>
  <last_update_submitted_qc>September 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial Fibrillation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 23, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT01694563/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were enrolled from: September 2012 thru October 2017</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Atrial Fibrillation</title>
          <description>Subjects enrolled exhibited the following types of Atrial fibrillation: Non-Paroxysmal, Persistent, and Long-Standing Persistent</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="365"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="278"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="87"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Atrial Fibrillation</title>
          <description>Patients with non-paroxysmal atrial fibrillation (persistent or longstanding persistent)who are scheduled to undergo elective concomitant open, on-pump cardiac surgical procedure and the Maze IV ablation procedure. This single arm registry is designed to monitor the AtriCure Synergy Ablation System for continued safety and efficacy during the peri-procedural and long term phase during commercial use.&#xD;
Synergy Ablation System: Patient will undergo an elective open cardiac surgical procedure to be performed on cardiopulmonary bypass for one or more of the following:&#xD;
Coronary Artery Bypass Grafting (CABG)&#xD;
Mitral valve repair or replacement&#xD;
Aortic valve repair or replacement&#xD;
Tricuspid valve repair or replacement The aim of the treatment is a complete bi-atrial Maze IV procedure which includes pulmonary vein isolation coupled with lesions made on both the left and right atria.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="365"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.8" lower_limit="36.7" upper_limit="87.7"/>
                  </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="148"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="217"/>
                  </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="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="331"/>
                  </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="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="365"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of Arrhythmia</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="365"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Number of Participants Free From Atrial Fibrillation (AF), Atrial Flutter or Atrial Tachycardia While Off Class I and Class III Antiarrhythmic Drugs for at Least 4 Weeks.</title>
        <description>The number of participants free from atrial fibrillation (AF), i.e., episodes lasting &gt;30 continuous seconds duration of either AF, atrial flutter or atrial tachycardia while off Class I and III antiarrythmic drugs for at least 4 weeks as determined by core last assessment of a 48 hour Holter, Zio Patch or Pacemaker Implantation (PPM) interrogation recording performed at a minimum of 36 months postoperatively.</description>
        <time_frame>36 months post-operatively</time_frame>
        <population>Freedom from AF and off antiarrhythmic drugs (AADs) at specific time points. The participants that met the endpoint are reflected in the Outcome Measure Data Table.</population>
        <group_list>
          <group group_id="O1">
            <title>36 Months Post-operatively</title>
            <description>The primary effectiveness outcome is defined as the proportion of patients free from AF (i.e. no episodes lasting &gt; 30 continuous seconds duration of either Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia) while off Class I and III antiarrhythmic drugs for at least 4 weeks as determined by an independent core lab assessment of 48 hour Holter, Zio™ Patch or PPM interrogation recording performed at a minimum of 36 months postoperatively.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Free From Atrial Fibrillation (AF), Atrial Flutter or Atrial Tachycardia While Off Class I and Class III Antiarrhythmic Drugs for at Least 4 Weeks.</title>
          <description>The number of participants free from atrial fibrillation (AF), i.e., episodes lasting &gt;30 continuous seconds duration of either AF, atrial flutter or atrial tachycardia while off Class I and III antiarrythmic drugs for at least 4 weeks as determined by core last assessment of a 48 hour Holter, Zio Patch or Pacemaker Implantation (PPM) interrogation recording performed at a minimum of 36 months postoperatively.</description>
          <population>Freedom from AF and off antiarrhythmic drugs (AADs) at specific time points. The participants that met the endpoint are reflected in the Outcome Measure Data Table.</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="232"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The primary effectiveness hypothesis for this study was to demonstrate a superiority success rate at 36-months follow-up in patients treated with the AtriCure Synergy Ablation System compared to a pre-established performance goal.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.05</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secondary Efficacy Outcome</title>
        <description>The proportion of patients free from AF, regardless of AAD usage (i.e. no episodes lasting &gt; 30 continuous seconds duration of either Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia), as determined by an independent core lab assessment of 48-hour Holter, Zio™ Patch or PPM interrogation recording performed at a minimum of 12,24, and 36 months post-operatively.</description>
        <time_frame>12, 24, and 36 months post-operatively</time_frame>
        <population>Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage. The participants that met the endpoint are reflected in the Outcome Measure Data Table.</population>
        <group_list>
          <group group_id="O1">
            <title>12 Months Post-operatively</title>
            <description>Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage.</description>
          </group>
          <group group_id="O2">
            <title>24 Months Post-operatively</title>
            <description>Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage.</description>
          </group>
          <group group_id="O3">
            <title>36 Months Post-operatively</title>
            <description>Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage.</description>
          </group>
        </group_list>
        <measure>
          <title>Secondary Efficacy Outcome</title>
          <description>The proportion of patients free from AF, regardless of AAD usage (i.e. no episodes lasting &gt; 30 continuous seconds duration of either Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia), as determined by an independent core lab assessment of 48-hour Holter, Zio™ Patch or PPM interrogation recording performed at a minimum of 12,24, and 36 months post-operatively.</description>
          <population>Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage. The participants that met the endpoint are reflected in the Outcome Measure Data Table.</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="271"/>
                <count group_id="O2" value="242"/>
                <count group_id="O3" value="228"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="216"/>
                    <measurement group_id="O2" value="187"/>
                    <measurement group_id="O3" value="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 12 months post-operatively.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Clopper-Pearson</param_type>
            <param_value>90</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>90% confidence interval calculated using the Clopper-Pearson method.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 24 months post-operatively.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Clopper-Pearson</param_type>
            <param_value>90</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>90% confidence interval calculated using the Clopper-Pearson method.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Secondary success was defined as freedom from AF regardless of antiarrhythmic drug usage at 36 months post-operatively.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Clopper-Pearson</param_type>
            <param_value>90</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <other_analysis_desc>90% confidence interval using the Clopper-Pearson method.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All adverse events were collected for 36 months.</time_frame>
      <desc>An adverse event is any untoward medical occurrence (signs, symptoms, abnormal laboratory findings) in a patient regardless of relationship to the device or procedure. Each adverse event is considered to be either anticipated or unanticipated as described below. The site is required to report all adverse events that occur in the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Treatment Arm</title>
          <description>Patients with non-paroxysmal atrial fibrillation ………..</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="289" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Coagulopathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="20" subjects_affected="20" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Ventricular Tachycardia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Venous Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Aortic Valve Incompetence</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Arrythmia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="45" subjects_affected="45" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Atrial Flutter</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Atrial Rupture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Atrial Tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Atrioventricular Block</sub_title>
                <counts group_id="E1" events="24" subjects_affected="24" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" events="90" subjects_affected="90" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Cardiac Tamponade</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Cardiogenic Shock</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Cardiorenal Syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory Arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Complete Heart Block</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Coronary Artery Occlusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Coronary Artery Stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Heart Valve Incompetence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Ischaemic cardiomyopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Left ventricular dysfunction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Mitral Valve Disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Mitral Valve incompetence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Mitral Valve stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Nodal Rhythm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Right ventricular failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Sick sinus syndrome</sub_title>
                <counts group_id="E1" events="29" subjects_affected="29" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Tricuspid valve incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Ventricular asystole</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Ventricular dysfunction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Left ventricular outflow tract obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Abdominal mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Colonic pseudo obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Gastrointestinal hemorrhage</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Intra-abdominal haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Rectal hemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="20" subjects_affected="20" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Multi-organ failure</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Porcelain gallbladder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Central line infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Diverticlitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Empyema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Enterococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Graft infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Groin infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Implant site infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="36" subjects_affected="36" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="18" subjects_affected="18" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Abdominal wound dehiscence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Alcohol poisoning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Hepatic haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Nerve injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Post procedural thoracic complication</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Traffic accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Subdural haemotoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Tracheostomy malfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Vascular pseudoaneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Vena cava injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Venous injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Wound dehiscence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Electrolyte imbalance</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Hypoglycemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Decreased mobility</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Osterarthritis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Spinal column stenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Leukaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Hypergammaglobulinaemia benign monoclonal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Myelodysplastic syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Oesophageal cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Anoxic encephalopothy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Coratid artery stenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Cerebral hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Dementia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Diabetic neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Facial paresis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Hemianopia homonymous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Hypoxic-ischaemic encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Metabolic encephalopathy</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Alcohol abuse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Alcohol withdrawal syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Anorexia nervosa</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="32" subjects_affected="32" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Renal tubular necrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ASPIRATION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>EPISTAXIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Haemothorax</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Mediastinal haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="40" subjects_affected="40" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Pulmonary congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Pulmonary vein stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Respiratory acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="65" subjects_affected="65" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Pharyngeal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Subcutaneous emphysema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Cardiac pacemaker revision</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Carotid endarterectomy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Hip arthroplasty</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Knee arthroplasty</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Mitral valve replacement</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Vertebroplasty</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Arterial insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Artery dissection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Femoral arterial stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" events="19" subjects_affected="19" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Shock haemorrhagic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA</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="271" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Aenemia</sub_title>
                <counts group_id="E1" events="22" subjects_affected="22" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="22" subjects_affected="22" subjects_at_risk="365"/>
              </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="48" subjects_affected="48" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="42" subjects_affected="38" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" events="59" subjects_affected="59" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" events="31" subjects_affected="31" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="28" subjects_affected="26" subjects_at_risk="365"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="21" subjects_affected="21" subjects_at_risk="365"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="30" subjects_affected="27" subjects_at_risk="365"/>
              </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 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>Nfii K. Ndikintum, PhD, MBA / VP, Clinical Affairs and Biometrics</name_or_title>
      <organization>Atricure Inc.</organization>
      <phone>513-644-8192</phone>
      <email>NNdikintum@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/NCT01694563
org study id: CP2011-1
nct id: NCT01694563
nct alias: NCT01174745
lead sponsor: 
has dmc: No
The primary objective of this post-approval study is to evaluate the clinical outcomes in a
      cohort of patients with non-paroxysmal forms of atrial fibrillation (persistent or
      long-standing persistent) treated during commercial use of the AtriCure Synergy Ablation
      System by physicians performed the Maze IV procedure.
This prospective, open label, multi-center, observational, single arm registry is designed to
      monitor the AtriCure Synergy Ablation System continued safety and efficacy during the
      peri-procedural and long-term phase during commercial use in patients being treated for
      non-paroxysmal forms of atrial fibrillation who are undergoing a concomitant open, on-pump
      cardiac surgical procedure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: open label
measure: The Number of Participants Free From Atrial Fibrillation (AF), Atrial Flutter or Atrial Tachycardia While Off Class I and Class III Antiarrhythmic Drugs for at Least 4 Weeks.
time frame: 36 months post-operatively
description: The number of participants free from atrial fibrillation (AF), i.e., episodes lasting >30 continuous seconds duration of either AF, atrial flutter or atrial tachycardia while off Class I and III antiarrythmic drugs for at least 4 weeks as determined by core last assessment of a 48 hour Holter, Zio Patch or Pacemaker Implantation (PPM) interrogation recording performed at a minimum of 36 months postoperatively.
measure: Secondary Efficacy Outcome
time frame: 12, 24, and 36 months post-operatively
description: The proportion of patients free from AF, regardless of AAD usage (i.e. no episodes lasting > 30 continuous seconds duration of either Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia), as determined by an independent core lab assessment of 48-hour Holter, Zio™ Patch or PPM interrogation recording performed at a minimum of 12,24, and 36 months post-operatively.
arm group label: Atrial Fibrillation
arm group type: Other
description: Patients with non-paroxysmal atrial fibrillation (persistent or longstanding persistent)who are scheduled to undergo elective concomitant open, on-pump cardiac surgical procedure and the Maze IV ablation procedure. This single arm registry is designed to monitor the AtriCure Synergy Ablation System for continued safety and efficacy during the peri-procedural and long term phase during commercial use.
intervention type: Device
intervention name: Synergy Ablation System
description: Patient will undergo an elective open cardiac surgical procedure to be performed on cardiopulmonary bypass for one or more of the following:
Coronary Artery Bypass Grafting (CABG)
Mitral valve repair or replacement
Aortic valve repair or replacement
Tricuspid valve repair or replacement The aim of the treatment is a complete bi-atrial Maze IV procedure which includes pulmonary vein isolation coupled with lesions made on both the left and right atria.
arm group label: Atrial Fibrillation
other name: Isolator Synergy Handpieces
other name: Isolator Synergy Clamp
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patrick McCarthy, MD
role: Study Chair
affiliation: Chief, Division of Cardiac Surgery, Northwestern University
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country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No
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