<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/NCT01687166</url>
  </required_header>
  <id_info>
    <org_study_id>CDM00048665</org_study_id>
    <nct_id>NCT01687166</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation</brief_title>
  <acronym>ZERO-AF</acronym>
  <official_title>Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to establish the safety and effectiveness of the Blazer&#xD;
      Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory,&#xD;
      recurrent, symptomatic, paroxysmal atrial fibrillation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ZERO-AF trial is a prospective, multicenter, single blind, 1:1 randomized study. The&#xD;
      trial is designed to demonstrate that the safety and effectiveness of the Blazer®&#xD;
      Open-Irrigated Ablation Catheter are non-inferior to the safety and effectiveness of the&#xD;
      control catheters, for the treatment drug refractory, recurrent, symptomatic, paroxysmal&#xD;
      atrial fibrillation. The control catheters are open-irrigated radiofrequency ablation&#xD;
      catheters that are approved in the United States for the treatment of drug refractory&#xD;
      recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible&#xD;
      three-dimensional electroanatomic mapping systems.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Procedure-related Complication Free Rate</measure>
    <time_frame>12 Months</time_frame>
    <description>The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group serious adverse event rate is non-inferior to that of the control group.&#xD;
The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group rate of significant pulmonary vein stenosis (≥70% reduction in diameter from baseline) and atrio-esophageal fistulas is non-inferior to that of the control group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chronic Success Rate</measure>
    <time_frame>Within 12 months of the index procedure</time_frame>
    <description>The primary effectiveness of the Blazer OI catheter will be evaluated by demonstrating that the proportion of subjects free from failure* in the investigational group is non-inferior to those in the control group.&#xD;
*failure is defined as a randomized subject being an acute procedural failure, having more than one repeat procedure during the 90 day blanking period or having a documented symptomatic atrial fibrillation, atrial tachycardia, atrial fibrillation between 91 days and 12 months post-procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute Success</measure>
    <time_frame>Acute- During Index Procedure, 20 minutes after confirmation of Pulmonary Vein Isolation</time_frame>
    <description>Demonstration that the investigational group acute procedural success rate is non-inferior to that of the control group. Acute procedural success is defined as a subject that successfully had all clinically relevant veins electrically isolated, by demonstration of entrance block at a minimum and no evidence of exit conduction with the randomized investigational or control catheter only.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">398</enrollment>
  <condition>Paroxysmal Atrial Fibrillation (PAF)</condition>
  <arm_group>
    <arm_group_label>Blazer Open-Irrigated Ablation Catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FDA Approved Open-Irrigated Ablation Catheter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blazer Open-Irrigated Ablation Catheter (Boston Scientific)</intervention_name>
    <arm_group_label>Blazer Open-Irrigated Ablation Catheter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FDA Approved Open-Irrigated Ablation Catheter</intervention_name>
    <arm_group_label>FDA Approved Open-Irrigated Ablation Catheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of recurrent symptomatic PAF with ≥2 episodes reported within the 365 days&#xD;
             prior to enrollment&#xD;
&#xD;
             o PAF is AF episodes that last ≥30 seconds in duration and terminate within 7 days.&#xD;
&#xD;
          -  At least 1 episode of PAF documented by Holter monitor, rhythm strip, trans-telephonic&#xD;
             monitor (TTM), or 12-lead ECG in the 365 days prior to enrollment&#xD;
&#xD;
          -  Refractory to at least one Beta Blocker, Calcium Channel Blocker, Class I OR Class III&#xD;
             anti-arrhythmic drug (AAD)&#xD;
&#xD;
          -  Age 18 or above, or of legal age to give informed consent specific to state and&#xD;
             national law&#xD;
&#xD;
          -  Competent and willing to provide written informed consent to participate in the study&#xD;
             and agree to comply with follow-up visits and evaluation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have any of the following heart conditions within 90 days prior to enrollment:&#xD;
&#xD;
               -  New York Heart Association (NYHA) Class III or IV&#xD;
&#xD;
               -  Left ventricular ejection fraction (LVEF) &lt;35%&#xD;
&#xD;
               -  Left atrial (LA) diameter &gt;5.5 cm&#xD;
&#xD;
               -  Unstable angina or ongoing myocardial ischemia&#xD;
&#xD;
               -  Transmural myocardial infarction (MI)&#xD;
&#xD;
          -  Congenital structural heart disease that increases the risk of ablation or precludes&#xD;
             catheter placement&#xD;
&#xD;
          -  Undergone any left atrial catheter or surgical ablation&#xD;
&#xD;
          -  Have had a coronary intervention, cardiac surgery, or other cardiac ablation within 90&#xD;
             days prior to enrollment&#xD;
&#xD;
          -  Had &gt;1 AF episode lasting greater than 7 days, with no episodes having lasted greater&#xD;
             than 30 days, within the past year&#xD;
&#xD;
          -  Subjects regularly prescribed amiodarone therapy during the 120 days prior to&#xD;
             enrollment&#xD;
&#xD;
          -  Contraindication to anticoagulation therapy&#xD;
&#xD;
          -  Creatinine &gt;2.5mg/dl or creatinine clearance &lt;30mL/min within 90 days (3 months) prior&#xD;
             to enrollment&#xD;
&#xD;
          -  Prosthetic mitral or tricuspid heart valves&#xD;
&#xD;
          -  Confirmed cardiac thrombus within 30 days (1 month) prior to enrollment&#xD;
&#xD;
          -  Implanted pacemaker, ICD, or CRT leads within 180 days (6 months) prior to enrollment&#xD;
&#xD;
          -  History of CVA, TIA or PE within 180 days (6 months) prior to enrollment&#xD;
&#xD;
          -  Left atrial appendage closure device&#xD;
&#xD;
          -  Any other significant uncontrolled or unstable medical condition (e.g. sepsis, acute&#xD;
             metabolic illness, end stage COPD)&#xD;
&#xD;
          -  Enrolled in any concurrent clinical trial without documented pre-approval from BSC&#xD;
&#xD;
          -  Women who are pregnant or plan to become pregnant within the course of their&#xD;
             participation in the investigation&#xD;
&#xD;
          -  Life expectancy ≤ 2 years (730 days) per physician opinion&#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>Andrea Natale, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Cardiac Arrhythmia Institute at St. David's Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunstville Hospital</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sequoia Hospital</name>
      <address>
        <city>Redwood City</city>
        <state>California</state>
        <zip>94062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent's Medical Center</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Hospital</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</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>Georgia Health Sciences University</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Union Memorial Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Caritas St. Elizabeth's Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109-5853</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>Jersey Shore University Medical Center</name>
      <address>
        <city>Neptune</city>
        <state>New Jersey</state>
        <zip>07754</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mt. Sinai Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strong Memorial Hospital of the University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina Medical Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Cardiac Arrhythmia Research Foundation</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trinity Mother of Frances Health System</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</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>Heart Care Partners</name>
      <address>
        <city>Brisbane</city>
        <state>Queensland</state>
        <zip>QL 4120 QLD</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>SA 5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Na Homolce Hospital</name>
      <address>
        <city>Prague</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU of Bordeaux</name>
      <address>
        <city>Pessac</city>
        <state>Gironde</state>
        <zip>33600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité University Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Staedtisches Klinikum Karlsruhe</name>
      <address>
        <city>Karlsruhe</city>
        <zip>76133</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospital de Santa Cruz</name>
      <address>
        <city>Carnaxide</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Y Provincial</name>
      <address>
        <city>Barcelona</city>
        <zip>8036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica Universitaria de Navarra</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Golden Jubilee National Hospital</name>
      <address>
        <city>Glasgow</city>
        <zip>G81 4DY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <results_first_submitted>February 15, 2018</results_first_submitted>
  <results_first_submitted_qc>June 15, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">June 18, 2018</results_first_posted>
  <last_update_submitted>October 24, 2018</last_update_submitted>
  <last_update_submitted_qc>October 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Paroxysmal Atrial Fibrillation</keyword>
  <keyword>Cardiac Arrhythmias</keyword>
  <keyword>Heart Disease</keyword>
  <keyword>Cardiovascular Disease</keyword>
  <keyword>Radiofrequency Ablation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acifluorfen</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Blazer Open-Irrigated Ablation Catheter</title>
          <description>Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system&#xD;
Blazer Open-Irrigated Ablation Catheter (Boston Scientific)</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.&#xD;
FDA Approved Open-Irrigated Ablation Catheter</description>
        </group>
        <group group_id="P3">
          <title>Blazer Open-Irrigated Ablation Catheter Roll-In</title>
          <description>Blazer Open-Irrigated Ablation Catheter Roll-In Subjects (Not randomized)</description>
        </group>
        <group group_id="P4">
          <title>Control Roll-In</title>
          <description>Non-Randomized Subjects treated with an FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.&#xD;
FDA Approved Open-Irrigated Ablation Catheter</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="167"/>
                <participants group_id="P2" count="172"/>
                <participants group_id="P3" count="56"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="139"/>
                <participants group_id="P2" count="145"/>
                <participants group_id="P3" count="42"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="27"/>
                <participants group_id="P3" count="14"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Attempt subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not meet eligibility criteria</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Equipment/Device Availability</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject moved out of state</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Patient unable to be compliant</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician choice to use different device</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Insurance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Blazer Open-Irrigated Ablation Catheter</title>
          <description>Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system&#xD;
Blazer Open-Irrigated Ablation Catheter (Boston Scientific)</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.&#xD;
FDA Approved Open-Irrigated Ablation Catheter</description>
        </group>
        <group group_id="B3">
          <title>Blazer Open-Irrigated Ablation Catheter Roll-In</title>
          <description>Blazer Open-Irrigated Ablation Catheter Roll-In Subjects (Not randomized)</description>
        </group>
        <group group_id="B4">
          <title>Control Roll-In</title>
          <description>Non-Randomized Subjects treated with an FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.&#xD;
FDA Approved Open-Irrigated Ablation Catheter</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="167"/>
            <count group_id="B2" value="172"/>
            <count group_id="B3" value="56"/>
            <count group_id="B4" value="3"/>
            <count group_id="B5" value="398"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60" spread="11"/>
                    <measurement group_id="B2" value="59" spread="10"/>
                    <measurement group_id="B3" value="62" spread="10"/>
                    <measurement group_id="B4" value="61" spread="10"/>
                    <measurement group_id="B5" value="60" spread="11"/>
                  </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="62"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="143"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="41"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="255"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Sweden</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                    <measurement group_id="B2" value="112"/>
                    <measurement group_id="B3" value="46"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="267"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Portugal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="173" spread="9"/>
                    <measurement group_id="B2" value="174" spread="9"/>
                    <measurement group_id="B3" value="175" spread="11"/>
                    <measurement group_id="B4" value="175" spread="11"/>
                    <measurement group_id="B5" value="174" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89" spread="19"/>
                    <measurement group_id="B2" value="90" spread="22"/>
                    <measurement group_id="B3" value="94" spread="21"/>
                    <measurement group_id="B4" value="79" spread="15"/>
                    <measurement group_id="B5" value="90" spread="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Resting Heart Rate</title>
          <units>bpm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71" spread="19"/>
                    <measurement group_id="B2" value="67" spread="15"/>
                    <measurement group_id="B3" value="68" spread="17"/>
                    <measurement group_id="B4" value="68" spread="7"/>
                    <measurement group_id="B5" value="69" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>New York Heart Assessment (NYHA) Class</title>
          <description>NYHA Class at enrollment based upon the following definitions:&#xD;
Class I - Subjects with heart disease who are able to remain at a comfortable state while performing ordinary physical activity Class II - Subjects who are comfortable at rest or with mild exertion but experience symptoms with more strenuous activity Class III - Subjects who are comfortable at rest but experience symptoms with mild activity Class IV - Subjects who are symptomatic at rest and are unable to carry out any physical activity</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>II</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non Heart Failure (HF)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Assessed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Procedure-related Complication Free Rate</title>
        <description>The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group serious adverse event rate is non-inferior to that of the control group.&#xD;
The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group rate of significant pulmonary vein stenosis (≥70% reduction in diameter from baseline) and atrio-esophageal fistulas is non-inferior to that of the control group.</description>
        <time_frame>12 Months</time_frame>
        <population>Outcome Measures were not assessed for the non-randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Blazer Open-Irrigated Ablation Catheter</title>
            <description>Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system&#xD;
Blazer Open-Irrigated Ablation Catheter (Boston Scientific)</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.&#xD;
FDA Approved Open-Irrigated Ablation Catheter</description>
          </group>
        </group_list>
        <measure>
          <title>Procedure-related Complication Free Rate</title>
          <description>The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group serious adverse event rate is non-inferior to that of the control group.&#xD;
The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group rate of significant pulmonary vein stenosis (≥70% reduction in diameter from baseline) and atrio-esophageal fistulas is non-inferior to that of the control group.</description>
          <population>Outcome Measures were not assessed for the non-randomized participants.</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="157"/>
                <count group_id="O2" value="164"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140"/>
                    <measurement group_id="O2" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Chronic Success Rate</title>
        <description>The primary effectiveness of the Blazer OI catheter will be evaluated by demonstrating that the proportion of subjects free from failure* in the investigational group is non-inferior to those in the control group.&#xD;
*failure is defined as a randomized subject being an acute procedural failure, having more than one repeat procedure during the 90 day blanking period or having a documented symptomatic atrial fibrillation, atrial tachycardia, atrial fibrillation between 91 days and 12 months post-procedure.</description>
        <time_frame>Within 12 months of the index procedure</time_frame>
        <population>Outcome Measures were not assessed for the non-randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Blazer Open-Irrigated Ablation Catheter</title>
            <description>Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system&#xD;
Blazer Open-Irrigated Ablation Catheter (Boston Scientific)</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.&#xD;
FDA Approved Open-Irrigated Ablation Catheter</description>
          </group>
        </group_list>
        <measure>
          <title>Chronic Success Rate</title>
          <description>The primary effectiveness of the Blazer OI catheter will be evaluated by demonstrating that the proportion of subjects free from failure* in the investigational group is non-inferior to those in the control group.&#xD;
*failure is defined as a randomized subject being an acute procedural failure, having more than one repeat procedure during the 90 day blanking period or having a documented symptomatic atrial fibrillation, atrial tachycardia, atrial fibrillation between 91 days and 12 months post-procedure.</description>
          <population>Outcome Measures were not assessed for the non-randomized participants.</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="157"/>
                <count group_id="O2" value="164"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acute Success</title>
        <description>Demonstration that the investigational group acute procedural success rate is non-inferior to that of the control group. Acute procedural success is defined as a subject that successfully had all clinically relevant veins electrically isolated, by demonstration of entrance block at a minimum and no evidence of exit conduction with the randomized investigational or control catheter only.</description>
        <time_frame>Acute- During Index Procedure, 20 minutes after confirmation of Pulmonary Vein Isolation</time_frame>
        <population>Outcome Measures were not assessed for the non-randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Blazer Open-Irrigated Ablation Catheter</title>
            <description>Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system&#xD;
Blazer Open-Irrigated Ablation Catheter (Boston Scientific)</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.&#xD;
FDA Approved Open-Irrigated Ablation Catheter</description>
          </group>
        </group_list>
        <measure>
          <title>Acute Success</title>
          <description>Demonstration that the investigational group acute procedural success rate is non-inferior to that of the control group. Acute procedural success is defined as a subject that successfully had all clinically relevant veins electrically isolated, by demonstration of entrance block at a minimum and no evidence of exit conduction with the randomized investigational or control catheter only.</description>
          <population>Outcome Measures were not assessed for the non-randomized participants.</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="157"/>
                <count group_id="O2" value="164"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="155"/>
                    <measurement group_id="O2" value="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from enrollment to end of follow-up ~12Months.</time_frame>
      <desc>Adverse event data is reported for treatment and attempt subjects.</desc>
      <group_list>
        <group group_id="E1">
          <title>Blazer Open-Irrigated Ablation Catheter Randomized</title>
          <description>Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system&#xD;
Blazer Open-Irrigated Ablation Catheter (Boston Scientific)</description>
        </group>
        <group group_id="E2">
          <title>FDA Approved Open-Irrigated Ablation Catheter Randomized</title>
          <description>FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.&#xD;
FDA Approved Open-Irrigated Ablation Catheter</description>
        </group>
        <group group_id="E3">
          <title>Blazer Open-Irrigated Ablation Catheter Roll-In</title>
          <description>Roll-In Cases for Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system&#xD;
Blazer Open-Irrigated Ablation Catheter (Boston Scientific)</description>
        </group>
        <group group_id="E4">
          <title>FDA Approved Open-Irrigated Ablation Catheter Roll-In</title>
          <description>Roll-In Cases for FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.&#xD;
FDA Approved Open-Irrigated Ablation Catheter</description>
        </group>
      </group_list>
      <serious_events>
        <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="1" subjects_at_risk="159"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="66" subjects_at_risk="159"/>
                <counts group_id="E2" subjects_affected="65" subjects_at_risk="167"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia (Ablation Procedure)</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation (AF)</sub_title>
                <counts group_id="E1" events="18" subjects_affected="18" subjects_at_risk="159"/>
                <counts group_id="E2" events="28" subjects_affected="27" subjects_at_risk="167"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Atrial flutter (type 1 Isthmus Dependent)</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Atrial tachycardia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Atypical Atrial Flutter</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="159"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Atypical atrial flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cardiac tamponade/perforation</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="159"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident (CVA)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chest pain - Heart failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Heart failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Heart failure symptoms - Unspecified</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Multiple heart failure symptoms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Other SVT (AVRT, AVNRT, EAT etc.</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pericardial Effusion (Ablation Procedure)</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pericarditis (Ablation Procedure)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Premature atrial contractions (PAC)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pulmonary Vein Stenosis - Significant (&gt;70%)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pulmonary edema - Heart failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism (PE)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Endocrine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="159"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="167"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adverse medication reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Alcohol dependency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="159"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fluid volume overload( i.e. diuresis, electrolyte imbalance) (Ablation Procedure)</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Head, eyes, ears, nose, throat (HEENT)</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="167"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>IV infiltrate</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Multiple symptoms</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sanguineous drainage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Systemic infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="159"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="167"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychological</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Genitourinary</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Renal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Renal insufficiency - Heart failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pulmonary</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="159"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>AV Fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hematoma (Ablation Procedure)</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Rectus sheath hematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="104" subjects_at_risk="159"/>
                <counts group_id="E2" subjects_affected="95" subjects_at_risk="167"/>
                <counts group_id="E3" subjects_affected="33" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hematological</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>1st degree AV block</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="159"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>2nd degree AV block</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Angina</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Aortic root atheromatosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Arrhythmia (Ablation Procedure)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Arterial/Venous Thromboembolic Events</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation (AF)</sub_title>
                <counts group_id="E1" events="22" subjects_affected="22" subjects_at_risk="159"/>
                <counts group_id="E2" events="33" subjects_affected="32" subjects_at_risk="167"/>
                <counts group_id="E3" events="12" subjects_affected="12" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Atrial flutter (type 1 Isthmus Dependent)</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="167"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Atrial tachycardia</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="159"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Atypical Atrial Flutter</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Bradycardia with pauses</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Breathing difficulties</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Brugada syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="159"/>
                <counts group_id="E2" events="9" subjects_affected="6" subjects_at_risk="167"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Chest pain - Ischemic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cyst on ascending aorta</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Heart failure symptoms - Unspecified</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="159"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hypotension (Ablation Procedure)</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Intracardiac thrombus with no thromboembolic event</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Intraventricular conduction delay</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Junctional ectopic rhythm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Long QT</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Multiple heart failure symptoms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Nonsustained ventricular tachycardia (NSVT)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Other SVT (AVRT, AVNRT, EAT etc.</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="159"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="167"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pericardial Effusion (Ablation Procedure)</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pericardial effusion - Unrelated to procedure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pleuritis (Ablation Procedure)</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Premature atrial contractions (PAC)</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="159"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Premature ventricular contractions (PVC)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pulmonary Vein Stenosis - Mild or Moderate (&lt;70%)</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pulmonary Vein Stenosis - Significant (&gt;70%)</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Right bundle branch block</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sinus arrhythmia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="159"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="167"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="159"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Tachycardia (Ablation Procedure)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Thrombus (No embolism) (Ablation Procedure)</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Typical atrial flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia (VT)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Endocrine</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Visual Blurring/Disturbances (Ablation Procedure)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cirrhosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gastrointestinal</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="159"/>
                <counts group_id="E2" events="12" subjects_affected="9" subjects_at_risk="167"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Gastroparesis (Ablation Procedure)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Increased GERD</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal laboratory values</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Adverse medication reaction</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="159"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="167"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Allergic reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Allergic reaction (Ablation Procedure)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Anesthesia/Sedation related complication (Ablation Procedure)</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Difficulty sleeping</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="167"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Exacerbation of existing condition (Ablation Procedure)</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Fluid retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Head, eyes, ears, nose, throat (HEENT)</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="159"/>
                <counts group_id="E2" events="14" subjects_affected="12" subjects_at_risk="167"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hemorrhage (Ablation Procedure)</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Integumentary</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="159"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Physical trauma</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Lyme disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Non-toxic LLE cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Musculoskeletal</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="159"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="167"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neurological</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pain neuromuscular/non cardiovascular (Ablation Procedure)</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Peripheral neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Psychological</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Genitourinary</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="159"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="167"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Renal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Dyspnea on exertion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pulmonary</sub_title>
                <counts group_id="E1" events="14" subjects_affected="11" subjects_at_risk="159"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="167"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Vagal denervation symptoms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>AV Fistula</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Edema (Ablation Procedure)</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Groin bleed (Ablation Procedure)</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Hematoma (Ablation Procedure)</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="159"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="167"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Peripheral edema</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Peripheral edema - Heart failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Pseudoaneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Swollen groin</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="159"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="167"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trial Manager</name_or_title>
      <organization>Boston Scientific</organization>
      <phone>617-218-3849</phone>
      <email>weismanm@bsci.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/NCT01687166
org study id: CDM00048665
nct id: NCT01687166
lead sponsor: 
has dmc: No
The purpose of this study is to establish the safety and effectiveness of the Blazer
      Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory,
      recurrent, symptomatic, paroxysmal atrial fibrillation.
The ZERO-AF trial is a prospective, multicenter, single blind, 1:1 randomized study. The
      trial is designed to demonstrate that the safety and effectiveness of the Blazer®
      Open-Irrigated Ablation Catheter are non-inferior to the safety and effectiveness of the
      control catheters, for the treatment drug refractory, recurrent, symptomatic, paroxysmal
      atrial fibrillation. The control catheters are open-irrigated radiofrequency ablation
      catheters that are approved in the United States for the treatment of drug refractory
      recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible
      three-dimensional electroanatomic mapping systems.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Procedure-related Complication Free Rate
time frame: 12 Months
description: The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group serious adverse event rate is non-inferior to that of the control group.
The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group rate of significant pulmonary vein stenosis (≥70% reduction in diameter from baseline) and atrio-esophageal fistulas is non-inferior to that of the control group.
measure: Chronic Success Rate
time frame: Within 12 months of the index procedure
description: The primary effectiveness of the Blazer OI catheter will be evaluated by demonstrating that the proportion of subjects free from failure* in the investigational group is non-inferior to those in the control group.
*failure is defined as a randomized subject being an acute procedural failure, having more than one repeat procedure during the 90 day blanking period or having a documented symptomatic atrial fibrillation, atrial tachycardia, atrial fibrillation between 91 days and 12 months post-procedure.
measure: Acute Success
time frame: Acute- During Index Procedure, 20 minutes after confirmation of Pulmonary Vein Isolation
description: Demonstration that the investigational group acute procedural success rate is non-inferior to that of the control group. Acute procedural success is defined as a subject that successfully had all clinically relevant veins electrically isolated, by demonstration of entrance block at a minimum and no evidence of exit conduction with the randomized investigational or control catheter only.
arm group label: Blazer Open-Irrigated Ablation Catheter
arm group type: Experimental
description: Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system
arm group label: FDA Approved Open-Irrigated Ablation Catheter
arm group type: Active Comparator
description: FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.
intervention type: Device
intervention name: Blazer Open-Irrigated Ablation Catheter (Boston Scientific)
arm group label: Blazer Open-Irrigated Ablation Catheter
intervention type: Device
intervention name: FDA Approved Open-Irrigated Ablation Catheter
arm group label: FDA Approved Open-Irrigated Ablation Catheter
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrea Natale, M.D.
role: Principal Investigator
affiliation: Texas Cardiac Arrhythmia Institute at St. David's Medical Center
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country: Australia
country: Czechia
country: France
country: Germany
country: Portugal
country: Spain
country: Sweden
country: United Kingdom
country: United States
country: Czech Republic
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Acifluorfen
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