<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/NCT01711983</url>
  </required_header>
  <id_info>
    <org_study_id>GSO 10-09</org_study_id>
    <nct_id>NCT01711983</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects</brief_title>
  <official_title>GORE® Septal Occluder Clinical Study: A Study to Evaluate Safety and Efficacy in the Treatment of Transcatheter Closure of Ostium Secundum Atrial Septal Defects (ASDs)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>W.L.Gore &amp; Associates</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>W.L.Gore &amp; Associates</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and&#xD;
      efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum&#xD;
      atrial septal defects (ASDs). The data obtained in this study will evaluate this next&#xD;
      generation device as compared to outcomes of prior studies conducted with the GORE® HELEX®&#xD;
      Septal Occluder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ostium secundum atrial septal defects present as a persistent communication between the atria&#xD;
      and are a common congenital cardiac anomaly accounting for approximately 10% of all&#xD;
      congenital heart disease. They are one of the most common congenital heart defects to present&#xD;
      in adulthood. Untreated, ASDs produce right heart volume overload and progressive impairment&#xD;
      over time, including reduced aerobic capacity, atrial dysrhythmias, congestive heart failure,&#xD;
      pulmonary hypertension, and potential paradoxical embolism. In the U.S. alone it is estimated&#xD;
      that approximately 10,000 new patients per year can be expected to have an ASD. Successful&#xD;
      surgical repair of ASD has been performed for 50 years with continued improvement in&#xD;
      technique and outcomes. King and Mills reported the first transcatheter closure of ASD in&#xD;
      1976, but the delivery system was quite large and impractical, especially for younger&#xD;
      patients. With time, improvements in design concepts and materials discoveries have led to&#xD;
      improved results in transcatheter closure systems. Several devices are now available&#xD;
      commercially for transcatheter ASD closure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">November 26, 2018</completion_date>
  <primary_completion_date type="Actual">November 26, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Subjects With 6-Month Composite Clinical Success</measure>
    <time_frame>6 months</time_frame>
    <description>Among subjects with attempted study device closure, the number of subjects who satisfy all of the following components:&#xD;
Technical Success: Successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder&#xD;
Safety Success:&#xD;
Freedom from any Serious Adverse Event (SAE) through 30 days post-procedure&#xD;
Freedom from device events (post-procedure embolization, device removal, or other device reintervention) from completion of the implant procedure through 6 months (195 days) post-procedure&#xD;
Closure Success: A clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Technical Success</measure>
    <time_frame>During procedure; median duration 68 minutes</time_frame>
    <description>Among subjects with attempted study device closure, the number of subjects with successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Procedure Success</measure>
    <time_frame>During procedure; median duration 68 minutes</time_frame>
    <description>Among subjects with attempted study device closure, the number of subjects with technical success and less than or equal to 2 mm residual shunt of the target ASD at conclusion of the index procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With 30-day SAE</measure>
    <time_frame>30 days</time_frame>
    <description>Among subjects with attempted study device closure, the number of subjects experiencing one or more serious adverse events (SAEs) within 30 days post-index procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With 6-Month Closure Success</measure>
    <time_frame>6 months</time_frame>
    <description>Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With 12-Month Closure Success</measure>
    <time_frame>12 months</time_frame>
    <description>Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 12-month evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With 36-Month Closure Success</measure>
    <time_frame>36 months</time_frame>
    <description>Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 36-month evaluation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Septal Defect, Atrial</condition>
  <arm_group>
    <arm_group_label>Test Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ASD closure with the GORE® CARDIOFORM Septal Occluder</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GORE® CARDIOFORM Septal Occluder</intervention_name>
    <description>Percutaneous Atrial Septal Defect Closure</description>
    <arm_group_label>Test Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASD less than or equal to 17 mm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Conditions that would confound treatment of ASD or complicate distinguishing onset of&#xD;
             adverse events.&#xD;
&#xD;
          -  Unable to accommodate device delivery catheter.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>D. Scott Lim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia, Children's Hospital Heart Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Virginia, Children's Hospital Heart Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <results_first_submitted>June 29, 2020</results_first_submitted>
  <results_first_submitted_qc>August 10, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 21, 2020</results_first_posted>
  <last_update_submitted>August 10, 2020</last_update_submitted>
  <last_update_submitted_qc>August 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Septal Defects</mesh_term>
    <mesh_term>Heart Septal Defects, Atrial</mesh_term>
    <mesh_term>Foramen Ovale, Patent</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 22, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT01711983/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Test Device</title>
          <description>ASD closure with the GORE® CARDIOFORM Septal Occluder&#xD;
Percutaneous Atrial Septal Defect Closure</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>6-Month Clinical Success Evaluation</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="400"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="368"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Missed Echocardiograph</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>6-Month Closure Evaluation</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="368"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="342"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Technical Failure (No Test Device)</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>36-Month Closure Evaluation</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="342"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="278"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Test Device Removal</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missed Echocardiograph</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Test Device</title>
          <description>ASD closure with the GORE® CARDIOFORM Septal Occluder</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="400"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="400"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.9" lower_limit="1.3" upper_limit="79.6"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="400"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="234"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="400"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="319"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="400"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="286"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="400"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="400"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="400"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="122.0" lower_limit="40.5" upper_limit="188.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="400"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.0" lower_limit="9.0" upper_limit="133.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hypertension</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="400"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Current</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Previous/Never</title>
                  <measurement_list>
                    <measurement group_id="B1" value="382"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes Mellitus</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="400"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Current</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Previous/Never</title>
                  <measurement_list>
                    <measurement group_id="B1" value="387"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cigarette Smoking</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="400"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Current</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Previous</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="B1" value="385"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Headaches</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="400"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Current</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Previous/Never</title>
                  <measurement_list>
                    <measurement group_id="B1" value="385"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Migraines</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="400"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Current</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Previous/Never</title>
                  <measurement_list>
                    <measurement group_id="B1" value="385"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cardiac Arrhythmia History</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="400"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Current</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Previous/Never</title>
                  <measurement_list>
                    <measurement group_id="B1" value="387"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stop Flow Balloon Defect Size</title>
          <population>Enrolled subjects with non-missing measurement</population>
          <units>mm</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="393"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.0" lower_limit="4.5" upper_limit="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Multiple Fenestrations</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="400"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Atrial Septal Aneurysm</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="400"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Septal Length</title>
          <population>Enrolled subjects with non-missing measurement</population>
          <units>mm</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="396"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.0" lower_limit="6.0" upper_limit="64.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Anterior-Superior Aortic Rim Length</title>
          <population>Enrolled subjects with non-missing measurement</population>
          <units>mm</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="396"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.0" lower_limit="0.0" upper_limit="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects With 6-Month Composite Clinical Success</title>
        <description>Among subjects with attempted study device closure, the number of subjects who satisfy all of the following components:&#xD;
Technical Success: Successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder&#xD;
Safety Success:&#xD;
Freedom from any Serious Adverse Event (SAE) through 30 days post-procedure&#xD;
Freedom from device events (post-procedure embolization, device removal, or other device reintervention) from completion of the implant procedure through 6 months (195 days) post-procedure&#xD;
Closure Success: A clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation</description>
        <time_frame>6 months</time_frame>
        <population>All enrolled subjects with 6-month clinical success evaluation</population>
        <group_list>
          <group group_id="O1">
            <title>Test Device</title>
            <description>ASD closure with the GORE® CARDIOFORM Septal Occluder</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With 6-Month Composite Clinical Success</title>
          <description>Among subjects with attempted study device closure, the number of subjects who satisfy all of the following components:&#xD;
Technical Success: Successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder&#xD;
Safety Success:&#xD;
Freedom from any Serious Adverse Event (SAE) through 30 days post-procedure&#xD;
Freedom from device events (post-procedure embolization, device removal, or other device reintervention) from completion of the implant procedure through 6 months (195 days) post-procedure&#xD;
Closure Success: A clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation</description>
          <population>All enrolled subjects with 6-month clinical success evaluation</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="368"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="332"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Test null hypothesis of inferiority of test device (test) compared to historical device (control).&#xD;
H0: Pc - Pt ≥ Δ vs H1: Pc - Pt &lt; Δ, where Pt and Pc are true proportions of 6-month clinical success for test and control, respectively, and Δ is the non-inferiority margin.&#xD;
Given Nc = 253, then Nt = 135 test subjects provides 86% power to reject H0 with 95% confidence if Δ = 0.10 and Pc = Pt = 0.866 under H0.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority margin based on 1) the lower 95% confidence bound (= 0.82) for estimated 6-month composite Clinical Success for the historical device (219/253=0.866), and 2) a worst-case analysis of 6-month composite Clinical Success for the historical device (0.81, assuming the 18 subjects with missing echo evaluations were failures).</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>A priori 1-sided alpha = 0.05.</p_value_desc>
            <method>2-sample binomial proportions test</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>-0.0366</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>0.007</ci_upper_limit>
            <estimate_desc>Difference is control - test. Confidence interval is the upper one-sided 95% Wald confidence interval.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Technical Success</title>
        <description>Among subjects with attempted study device closure, the number of subjects with successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder</description>
        <time_frame>During procedure; median duration 68 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Device</title>
            <description>ASD closure with the GORE® CARDIOFORM Septal Occluder</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Technical Success</title>
          <description>Among subjects with attempted study device closure, the number of subjects with successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="400"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="374"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Procedure Success</title>
        <description>Among subjects with attempted study device closure, the number of subjects with technical success and less than or equal to 2 mm residual shunt of the target ASD at conclusion of the index procedure.</description>
        <time_frame>During procedure; median duration 68 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Device</title>
            <description>ASD closure with the GORE® CARDIOFORM Septal Occluder</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Procedure Success</title>
          <description>Among subjects with attempted study device closure, the number of subjects with technical success and less than or equal to 2 mm residual shunt of the target ASD at conclusion of the index procedure.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="400"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="364"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With 30-day SAE</title>
        <description>Among subjects with attempted study device closure, the number of subjects experiencing one or more serious adverse events (SAEs) within 30 days post-index procedure</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test Device</title>
            <description>ASD closure with the GORE® CARDIOFORM Septal Occluder</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With 30-day SAE</title>
          <description>Among subjects with attempted study device closure, the number of subjects experiencing one or more serious adverse events (SAEs) within 30 days post-index procedure</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="400"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With 6-Month Closure Success</title>
        <description>Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation.</description>
        <time_frame>6 months</time_frame>
        <population>Enrolled subjects with technical success and 6-month clinical residual defect status evaluation</population>
        <group_list>
          <group group_id="O1">
            <title>Test Device</title>
            <description>ASD closure with the GORE® CARDIOFORM Septal Occluder</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With 6-Month Closure Success</title>
          <description>Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation.</description>
          <population>Enrolled subjects with technical success and 6-month clinical residual defect status evaluation</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="342"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="338"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With 12-Month Closure Success</title>
        <description>Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 12-month evaluation.</description>
        <time_frame>12 months</time_frame>
        <population>Enrolled subjects with technical success and 12-month clinical residual defect status evaluation</population>
        <group_list>
          <group group_id="O1">
            <title>Test Device</title>
            <description>ASD closure with the GORE® CARDIOFORM Septal Occluder</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With 12-Month Closure Success</title>
          <description>Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 12-month evaluation.</description>
          <population>Enrolled subjects with technical success and 12-month clinical residual defect status evaluation</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="340"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="337"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With 36-Month Closure Success</title>
        <description>Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 36-month evaluation.</description>
        <time_frame>36 months</time_frame>
        <population>Enrolled subjects with technical success and 36-month clinical residual defect status evaluation</population>
        <group_list>
          <group group_id="O1">
            <title>Test Device</title>
            <description>ASD closure with the GORE® CARDIOFORM Septal Occluder</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With 36-Month Closure Success</title>
          <description>Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 36-month evaluation.</description>
          <population>Enrolled subjects with technical success and 36-month clinical residual defect status evaluation</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="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="277"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 years (1,155 days: 1,095 days + 60-day window)</time_frame>
      <desc>SAEs follow definition of SAE from ISO 14155.</desc>
      <group_list>
        <group group_id="E1">
          <title>Test Device</title>
          <description>ASD closure with the GORE® CARDIOFORM Septal Occluder</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 21.1</default_vocab>
        <default_assessment>Non-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="0" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Atrial thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Atrioventricular block first degree</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial septal defect</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Frenulum breve</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Hydrocele</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Cerumen impaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Middle ear effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Medical device site thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Amyloidosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Croup infectious</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Streptococcal sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Foreign body in gastrointestinal tract</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Post concussion syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute lymphocytic leukaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhagic ovarian cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Penile adhesion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Adenoidal hypertrophy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Bronchial hyperreactivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Pharyngeal hypertrophy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Tonsillar hypertrophy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Upper airway obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Caesarean section</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA Version 21.1</default_vocab>
        <default_assessment>Non-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="260" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Increased tendency to bruise</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Atrioventricular block first degree</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Atrioventricular block second degree</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Cardiac septal hypertrophy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Dilatation atrial</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Extrasystoles</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Left ventricular dilatation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Left ventricular dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Left ventricular hypertrophy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Nodal rhythm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="17" subjects_affected="16" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Postural orthostatic tachycardia syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Pulmonary valve stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Sinus node dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Supraventricular extrasystoles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Tachyarrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Tricuspid valve incompetence</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Williams syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Cerumen impaction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Ear discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Eustachian tube dysfunction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Tympanic membrane disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Tympanic membrane perforation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Thyroid disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Orbital cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Strabismus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Vitreous floaters</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Diarrhoea haemorrhagic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Tongue disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="26" subjects_affected="24" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Axillary pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Cardiac complication associated with device</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Decreased activity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Exercise tolerance decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Infusion site extravasation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Nodule</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="38" subjects_affected="31" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="18" subjects_affected="18" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Multiple allergies</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acarodermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Bacterial disease carrier</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Croup infectious</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Enterovirus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Gastrointestinal viral infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Hand-foot-and-mouth disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Impetigo</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Lyme disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Molluscum contagiosum</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Oral viral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Otitis media chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Rhinovirus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Rotavirus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Staphylococcal skin infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="27" subjects_affected="24" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Urethritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Viral rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Vulvovaginitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Anaesthetic complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Anaesthetic complication cardiac</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Anaesthetic complication pulmonary</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Cardiac procedure complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Corneal abrasion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis postoperative</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Delayed recovery from anaesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Forearm fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Incision site complication</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Incision site haematoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Incision site haemorrhage</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Incision site pain</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Incision site rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Ligament injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Post procedural fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Procedural headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Procedural nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Scapula fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Splinter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Superficial injury of eye</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Vascular pseudoaneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Cardiac murmur</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Chest X-ray abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Appetite disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Hyperphosphataemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Costochondritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Infrapatellar fat pad inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Juvenile idiopathic arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lipoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Pyogenic granuloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Skin papilloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Allodynia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Dysaesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Febrile convulsion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="45" subjects_affected="41" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Migraine with aura</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Migraine without aura</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Vocal cord paresis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device issue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Attention deficit/hyperactivity disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Hallucination, auditory</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Penile curvature</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Adenoidal hypertrophy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Apnoeic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Bronchomalacia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="17" subjects_affected="16" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Laryngeal oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Laryngospasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Snoring</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Stridor</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Tonsillar hypertrophy</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Tonsillar inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Dermatitis diaper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Mechanical urticaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Pityriasis rosea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Seborrhoeic dermatitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Knee operation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Air embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Angiopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Carotidynia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Labile hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
              <event>
                <sub_title>Vascular dissection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="400"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Bryan Randall</name_or_title>
      <organization>W. L. Gore &amp; Associates</organization>
      <phone>928-864-4832</phone>
      <email>BRandall@WLGore.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/NCT01711983
org study id: GSO 10-09
nct id: NCT01711983
lead sponsor: 
has dmc: Yes
The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and
      efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum
      atrial septal defects (ASDs). The data obtained in this study will evaluate this next
      generation device as compared to outcomes of prior studies conducted with the GORE® HELEX®
      Septal Occluder.
Ostium secundum atrial septal defects present as a persistent communication between the atria
      and are a common congenital cardiac anomaly accounting for approximately 10% of all
      congenital heart disease. They are one of the most common congenital heart defects to present
      in adulthood. Untreated, ASDs produce right heart volume overload and progressive impairment
      over time, including reduced aerobic capacity, atrial dysrhythmias, congestive heart failure,
      pulmonary hypertension, and potential paradoxical embolism. In the U.S. alone it is estimated
      that approximately 10,000 new patients per year can be expected to have an ASD. Successful
      surgical repair of ASD has been performed for 50 years with continued improvement in
      technique and outcomes. King and Mills reported the first transcatheter closure of ASD in
      1976, but the delivery system was quite large and impractical, especially for younger
      patients. With time, improvements in design concepts and materials discoveries have led to
      improved results in transcatheter closure systems. Several devices are now available
      commercially for transcatheter ASD closure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Subjects With 6-Month Composite Clinical Success
time frame: 6 months
description: Among subjects with attempted study device closure, the number of subjects who satisfy all of the following components:
Technical Success: Successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder
Safety Success:
Freedom from any Serious Adverse Event (SAE) through 30 days post-procedure
Freedom from device events (post-procedure embolization, device removal, or other device reintervention) from completion of the implant procedure through 6 months (195 days) post-procedure
Closure Success: A clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation
measure: Number of Subjects With Technical Success
time frame: During procedure; median duration 68 minutes
description: Among subjects with attempted study device closure, the number of subjects with successful deployment and retention at conclusion of index procedure of a GORE® CARDIOFORM Septal Occluder
measure: Number of Subjects With Procedure Success
time frame: During procedure; median duration 68 minutes
description: Among subjects with attempted study device closure, the number of subjects with technical success and less than or equal to 2 mm residual shunt of the target ASD at conclusion of the index procedure.
measure: Number of Subjects With 30-day SAE
time frame: 30 days
description: Among subjects with attempted study device closure, the number of subjects experiencing one or more serious adverse events (SAEs) within 30 days post-index procedure
measure: Number of Subjects With 6-Month Closure Success
time frame: 6 months
description: Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 6-month evaluation.
measure: Number of Subjects With 12-Month Closure Success
time frame: 12 months
description: Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 12-month evaluation.
measure: Number of Subjects With 36-Month Closure Success
time frame: 36 months
description: Among subjects with technical success, the number of subjects with clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 36-month evaluation.
arm group label: Test Device
arm group type: Experimental
description: ASD closure with the GORE® CARDIOFORM Septal Occluder
intervention type: Device
intervention name: GORE® CARDIOFORM Septal Occluder
description: Percutaneous Atrial Septal Defect Closure
arm group label: Test Device
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: D. Scott Lim, MD
role: Principal Investigator
affiliation: University of Virginia, Children's Hospital Heart Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Septal Defects
mesh term: Heart Septal Defects, Atrial
mesh term: Foramen Ovale, Patent
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 