<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/NCT02985684</url>
  </required_header>
  <id_info>
    <org_study_id>ASD 15-04</org_study_id>
    <nct_id>NCT02985684</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs</brief_title>
  <acronym>ASSURED</acronym>
  <official_title>GORE® CARDIOFORM ASD Occluder Clinical Study: A Study to Evaluate Safety and Efficacy in the Treatment of Transcatheter Closure of Ostium Secundum Atrial Septal Defects (ASDs) - The Gore ASSURED Clinical Study</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous&#xD;
      closure of ostium secundum atrial septal defects (ASDs)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multicenter, single-arm clinical study comparing outcomes with the&#xD;
      GORE® CARDIOFORM ASD Occluder to performance goals derived from clinical investigation&#xD;
      outcomes for devices indicated for ASD closure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 10, 2017</start_date>
  <completion_date type="Actual">September 29, 2022</completion_date>
  <primary_completion_date type="Actual">July 30, 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 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>
  </primary_outcome>
  <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 ASD Occluder&#xD;
Safety Success:&#xD;
Freedom from any Serious Adverse Event (SAE) related to the device or procedure as adjudicated by the Independent Data Review Board (IDRB) 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 (180 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 67 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 ASD Occluder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Procedure Success</measure>
    <time_frame>During procedure; median duration 67 minutes</time_frame>
    <description>Among subjects with attempted study device closure, the number of subjects with technical success and measured residual defect status of occluded, small, or moderate of the target ASD at conclusion of index procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With 30-day IDRB-adjudicated Device- or Procedure-related SAE</measure>
    <time_frame>30 days</time_frame>
    <description>Among subjects with attempted study device closure, the number of subjects experiencing one or more device- or procedure-related serious adverse events (SAEs) within 30 days post-index procedure as adjudicated by the Independent Data Review Board (IDRB)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measured Residual Target Defect Size</measure>
    <time_frame>6 months</time_frame>
    <description>Measured residual defect size (in millimeters) as determined by the Echo Core Lab at the 6-month evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Clinically Significant New Arrhythmia</measure>
    <time_frame>6 months</time_frame>
    <description>The number of subjects with any new arrhythmia (documented on ECG) requiring hospitalization, initiation of new long-term medical therapy (persisting &gt; 45 days), or any post-index procedure cardioversion or intervention (pacemaker, ablation, etc.) in subjects without prior history of arrhythmia, as adjudicated by the Independent Data Review Board</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Wire Frame Fracture</measure>
    <time_frame>6 months</time_frame>
    <description>Among subjects with technical success, the number of subjects with wire frame fracture as determined by fluoroscopy at the 6-month evaluation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Atrial Septal Defect</condition>
  <arm_group>
    <arm_group_label>Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ASD closure with the GORE® CARDIOFORM ASD Occluder</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GORE® CARDIOFORM ASD Occluder</intervention_name>
    <description>Percutaneous Atrial Septal Defect Closure</description>
    <arm_group_label>Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All responses must be Yes to be eligible:&#xD;
&#xD;
          1. Patient has an ostium secundum ASD with evidence of left-to-right shunt and right&#xD;
             ventricular volume overload.&#xD;
&#xD;
          2. Patient has a defect size 8-35 mm as measured directly by stop-flow balloon sizing.&#xD;
&#xD;
          3. Patient vasculature can accommodate the delivery system and procedural accessories.&#xD;
&#xD;
          4. Patient can accommodate TEE or intracardiac echocardiography (ICE) probe for implant&#xD;
             procedure.&#xD;
&#xD;
          5. Patient is judged by the implanting physician to have adequate septal rims to retain&#xD;
             the study device.&#xD;
&#xD;
          6. Patient (or legal guardian, if patient is a minor) will voluntarily sign a Patient&#xD;
             Informed Consent Form (ICF) specific to the study. The Patient ICF must be reviewed&#xD;
             and approved in a manner that complies with requirements of the hospital's&#xD;
             Institutional Review Board (IRB).&#xD;
&#xD;
          7. Patient (and legal guardian, if patient is a minor) is physically and mentally willing&#xD;
             to comply with all study follow-up requirements through 36 months, including routinely&#xD;
             scheduled diagnostic testing and physical examinations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        All responses must be No to be eligible:&#xD;
&#xD;
          1. Patient has significant known pre-existing electrophysiologic or structural&#xD;
             cardiovascular defect, or other comorbidities that could elevate morbidity or&#xD;
             mortality beyond what is common for ASD or would require surgical treatment within&#xD;
             three (3) years of device placement. Examples include, but are not limited to, large&#xD;
             ventricular septal defect, hypoplastic left heart syndrome, coarctation,&#xD;
             univentricular heart or tricuspid atresia, pulmonary hypertension, coronary artery&#xD;
             disease, valvular or myocardial dysfunction, and other congenital heart disease&#xD;
             requiring surgical repair.&#xD;
&#xD;
          2. Patient has systemic or inherited conditions that would significantly increase risk of&#xD;
             major morbidity and mortality during the term of the study. Examples include&#xD;
             endocarditis, cancer, degenerative neuromuscular disorder, cardiomyopathy, and any&#xD;
             condition expected to result in significant deterioration of health within three (3)&#xD;
             years of the index procedure.&#xD;
&#xD;
          3. Patient has anatomy where the size or position of the occluder would interfere with&#xD;
             other intracardiac or intravasculature structures, such as cardiac valves or pulmonary&#xD;
             veins.&#xD;
&#xD;
          4. Patient has active endocarditis, other infections producing bacteremia, or has known&#xD;
             sepsis within one month of planned implantation, or any other infection that cannot be&#xD;
             treated successfully prior to device placement.&#xD;
&#xD;
          5. Patient has known intracardiac thrombi.&#xD;
&#xD;
          6. Patient has an uncontrolled arrhythmia with evidence of arrhythmia control failure&#xD;
             within the past 90 days (e.g., supraventricular tachycardia while under rate control&#xD;
             or atrial fibrillation while under rhythm control) or requires electrophysiology study&#xD;
             or concomitant intervention with device placement.&#xD;
&#xD;
          7. Patient is awaiting a procedure that requires trans-septal left atrial access within 6&#xD;
             months of implant procedure.&#xD;
&#xD;
          8. Patient has a history of stroke resulting in a significant morbidity or disability.&#xD;
&#xD;
          9. Patient is pregnant or lactating at time of screening.&#xD;
&#xD;
         10. Patient has contraindication to antiplatelet and anticoagulant medications.&#xD;
&#xD;
         11. Patient has elevated pulmonary vascular resistance (PVR) which in the opinion of the&#xD;
             implanting physician precludes safe defect closure.&#xD;
&#xD;
         12. Patient has multiple defects based on screening imaging and stop-flow balloon sizing&#xD;
             that would require placement of more than one device.&#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>Robert Sommer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University of New York</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Matthew Gillespie, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Philadelphia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Phoenix Children's Hospital</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California-Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nicklaus Children's Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Healthcare at Egleston</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riley Hospital for Children</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Boston</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Michigan</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic - Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center/New York Presbyterian Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atrium Health</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital &amp; Regional Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <results_first_submitted>November 7, 2019</results_first_submitted>
  <results_first_submitted_qc>December 18, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 7, 2020</results_first_posted>
  <last_update_submitted>June 7, 2023</last_update_submitted>
  <last_update_submitted_qc>June 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2023</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 6, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT02985684/Prot_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 27, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/84/NCT02985684/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Device</title>
          <description>ASD closure with the GORE® CARDIOFORM ASD Occluder&#xD;
GORE® CARDIOFORM ASD Occluder: 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="125"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Missed Echocardiograph</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>6-Month Closure Success Evaluation</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="112"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Technical Failure (No Device)</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Device Removal</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All enrolled pivotal subjects</population>
      <group_list>
        <group group_id="B1">
          <title>Device</title>
          <description>ASD closure with the GORE® CARDIOFORM ASD Occluder&#xD;
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="125"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.3" lower_limit="2.9" upper_limit="84.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </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>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="125"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="148" lower_limit="85" upper_limit="191"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.5" lower_limit="12.0" upper_limit="105.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hypercholesterolemia</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Current</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Previous/Never</title>
                  <measurement_list>
                    <measurement group_id="B1" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hypertension</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Current</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Previous/Never</title>
                  <measurement_list>
                    <measurement group_id="B1" value="119"/>
                  </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>
              <category_list>
                <category>
                  <title>Current</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Previous/Never</title>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Nicotene Use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Within past year</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;1 year ago</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="B1" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Headaches or Migraines</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <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="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stop Flow Balloon Defect Size</title>
          <units>mm</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17" lower_limit="8" upper_limit="30"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Septal Length</title>
          <units>mm</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39" lower_limit="21" upper_limit="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Anterior-Superior Aortic Rim Length</title>
          <units>mm</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4" lower_limit="0" upper_limit="27"/>
                  </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 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>Pivotal subjects with technical success and 6-month clinical residual defect status evaluation</population>
        <group_list>
          <group group_id="O1">
            <title>Device</title>
            <description>ASD closure with the GORE® CARDIOFORM ASD Occluder&#xD;
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure</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>Pivotal 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="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112"/>
                  </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 equal or lesser proportion with 6-month closure success compared to a performance goal (PG).&#xD;
H0: P ≤ 0.88 vs H1: P &gt; 0.88, where P is the true proportion of subjects with 6-month closure success and 0.88 is the PG derived from clinical study outcomes for devices indicated for ASD closure.&#xD;
N=103 subjects provide ≥95% power to exclude PG with 95% confidence if P=0.98 under H1.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Acceptable performance: favorably exclude PG=0.88 with 95% confidence. Expected 6-month closure success proportion = 0.98. Acceptable performance margin = 0.10. PG = 0.98 - 0.10 = 0.88.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>A priori 1-sided alpha = 0.05. If test rejects H0, then test primary outcome 2 (clinical success) at 1-sided alpha = 0.05; otherwise testing stops with failure to reject both primary outcome null hypotheses.</p_value_desc>
            <method>Binomial test (exact)</method>
            <param_type>Binomial proportion</param_type>
            <param_value>1.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_lower_limit>0.974</ci_lower_limit>
            <estimate_desc>Exact 1-sided confidence interval lower bound from Clopper-Pearson method.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <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 ASD Occluder&#xD;
Safety Success:&#xD;
Freedom from any Serious Adverse Event (SAE) related to the device or procedure as adjudicated by the Independent Data Review Board (IDRB) 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 (180 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 pivotal subjects with 6-month clinical success evaluation</population>
        <group_list>
          <group group_id="O1">
            <title>Device</title>
            <description>ASD closure with the GORE® CARDIOFORM ASD Occluder&#xD;
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure</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 ASD Occluder&#xD;
Safety Success:&#xD;
Freedom from any Serious Adverse Event (SAE) related to the device or procedure as adjudicated by the Independent Data Review Board (IDRB) 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 (180 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 pivotal 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="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                  </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 equal or lesser proportion with 6-month clinical success compared to a performance goal (PG).&#xD;
H0: P ≤ 0.76 vs H1: P &gt; 0.76, where P is the true proportion of subjects with 6-month clinical success and 0.76 is the PG derived from clinical study outcomes for devices indicated for ASD closure.&#xD;
N=112 subjects provide 95% power to exclude PG with 95% confidence if P=0.88 under H1.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Acceptable performance: favorably exclude PG=0.76 with 95% confidence. Expected 6-month clinical success proportion = 0.88. Acceptable performance margin = 0.12. PG = 0.88 - 0.12 = 0.76.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>A priori 1-sided alpha = 0.05. If test of primary outcome 1 rejects H0, then test at 1-sided alpha = 0.05; otherwise no testing of this primary outcome and failure to reject null hypothesis.</p_value_desc>
            <method>Binomial test (exact)</method>
            <param_type>Binomial proportion</param_type>
            <param_value>0.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_lower_limit>0.843</ci_lower_limit>
            <estimate_desc>Exact 1-sided confidence interval lower bound from Clopper-Pearson method.</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 ASD Occluder</description>
        <time_frame>During procedure; median duration 67 minutes</time_frame>
        <population>All pivotal subjects enrolled</population>
        <group_list>
          <group group_id="O1">
            <title>Device</title>
            <description>ASD closure with the GORE® CARDIOFORM ASD Occluder&#xD;
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure</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 ASD Occluder</description>
          <population>All pivotal subjects enrolled</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="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120"/>
                  </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 measured residual defect status of occluded, small, or moderate of the target ASD at conclusion of index procedure</description>
        <time_frame>During procedure; median duration 67 minutes</time_frame>
        <population>All pivotal subjects enrolled</population>
        <group_list>
          <group group_id="O1">
            <title>Device</title>
            <description>ASD closure with the GORE® CARDIOFORM ASD Occluder&#xD;
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure</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 measured residual defect status of occluded, small, or moderate of the target ASD at conclusion of index procedure</description>
          <population>All pivotal subjects enrolled</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="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With 30-day IDRB-adjudicated Device- or Procedure-related SAE</title>
        <description>Among subjects with attempted study device closure, the number of subjects experiencing one or more device- or procedure-related serious adverse events (SAEs) within 30 days post-index procedure as adjudicated by the Independent Data Review Board (IDRB)</description>
        <time_frame>30 days</time_frame>
        <population>All enrolled pivotal subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Device</title>
            <description>ASD closure with the GORE® CARDIOFORM ASD Occluder&#xD;
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With 30-day IDRB-adjudicated Device- or Procedure-related SAE</title>
          <description>Among subjects with attempted study device closure, the number of subjects experiencing one or more device- or procedure-related serious adverse events (SAEs) within 30 days post-index procedure as adjudicated by the Independent Data Review Board (IDRB)</description>
          <population>All enrolled pivotal subjects</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="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Measured Residual Target Defect Size</title>
        <description>Measured residual defect size (in millimeters) as determined by the Echo Core Lab at the 6-month evaluation.</description>
        <time_frame>6 months</time_frame>
        <population>Pivotal subjects with technical success and 6-month measured residual defect status evaluation</population>
        <group_list>
          <group group_id="O1">
            <title>Device</title>
            <description>ASD closure with the GORE® CARDIOFORM ASD Occluder&#xD;
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure</description>
          </group>
        </group_list>
        <measure>
          <title>Measured Residual Target Defect Size</title>
          <description>Measured residual defect size (in millimeters) as determined by the Echo Core Lab at the 6-month evaluation.</description>
          <population>Pivotal subjects with technical success and 6-month measured residual defect status evaluation</population>
          <units>mm</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Clinically Significant New Arrhythmia</title>
        <description>The number of subjects with any new arrhythmia (documented on ECG) requiring hospitalization, initiation of new long-term medical therapy (persisting &gt; 45 days), or any post-index procedure cardioversion or intervention (pacemaker, ablation, etc.) in subjects without prior history of arrhythmia, as adjudicated by the Independent Data Review Board</description>
        <time_frame>6 months</time_frame>
        <population>All pivotal subjects enrolled -- prior history of arrhythmia reported on the medical history form does not preclude assessment for, and finding of, clinically significant new arrhythmia from adjudication by the Independent Data Review Board</population>
        <group_list>
          <group group_id="O1">
            <title>Device</title>
            <description>ASD closure with the GORE® CARDIOFORM ASD Occluder&#xD;
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Clinically Significant New Arrhythmia</title>
          <description>The number of subjects with any new arrhythmia (documented on ECG) requiring hospitalization, initiation of new long-term medical therapy (persisting &gt; 45 days), or any post-index procedure cardioversion or intervention (pacemaker, ablation, etc.) in subjects without prior history of arrhythmia, as adjudicated by the Independent Data Review Board</description>
          <population>All pivotal subjects enrolled -- prior history of arrhythmia reported on the medical history form does not preclude assessment for, and finding of, clinically significant new arrhythmia from adjudication by the Independent Data Review Board</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="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Wire Frame Fracture</title>
        <description>Among subjects with technical success, the number of subjects with wire frame fracture as determined by fluoroscopy at the 6-month evaluation.</description>
        <time_frame>6 months</time_frame>
        <population>Pivotal subjects with technical success and 6-month fluoroscopy evaluation</population>
        <group_list>
          <group group_id="O1">
            <title>Device</title>
            <description>ASD closure with the GORE® CARDIOFORM ASD Occluder&#xD;
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Wire Frame Fracture</title>
          <description>Among subjects with technical success, the number of subjects with wire frame fracture as determined by fluoroscopy at the 6-month evaluation.</description>
          <population>Pivotal subjects with technical success and 6-month fluoroscopy 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="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months (180 days)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Device</title>
          <description>ASD closure with the GORE® CARDIOFORM ASD Occluder&#xD;
GORE® CARDIOFORM ASD Occluder: Percutaneous Atrial Septal Defect Closure</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Device embolisation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Migraine with aura</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Thrombosis in device</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA Version 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="57" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhagic anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Atrial tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Tricuspid valve incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Enlarged uvula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter site haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Croup infectious</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Hand-foot-and-mouth disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Trichomoniasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Foreign body in gastrointestinal tract</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Incision site haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Incision site haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Electrocardiogram ST segment elevation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Heart rate decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Costochondritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Cystitis haemorrhagic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Endometriosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Laryngospasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Pharyngeal exudate</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Perioral dermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </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/NCT02985684
org study id: ASD 15-04
nct id: NCT02985684
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous
      closure of ostium secundum atrial septal defects (ASDs)
This is a prospective, multicenter, single-arm clinical study comparing outcomes with the
      GORE® CARDIOFORM ASD Occluder to performance goals derived from clinical investigation
      outcomes for devices indicated for ASD closure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
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 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 ASD Occluder
Safety Success:
Freedom from any Serious Adverse Event (SAE) related to the device or procedure as adjudicated by the Independent Data Review Board (IDRB) 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 (180 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 67 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 ASD Occluder
measure: Number of Subjects With Procedure Success
time frame: During procedure; median duration 67 minutes
description: Among subjects with attempted study device closure, the number of subjects with technical success and measured residual defect status of occluded, small, or moderate of the target ASD at conclusion of index procedure
measure: Number of Subjects With 30-day IDRB-adjudicated Device- or Procedure-related SAE
time frame: 30 days
description: Among subjects with attempted study device closure, the number of subjects experiencing one or more device- or procedure-related serious adverse events (SAEs) within 30 days post-index procedure as adjudicated by the Independent Data Review Board (IDRB)
measure: Measured Residual Target Defect Size
time frame: 6 months
description: Measured residual defect size (in millimeters) as determined by the Echo Core Lab at the 6-month evaluation.
measure: Number of Subjects With Clinically Significant New Arrhythmia
time frame: 6 months
description: The number of subjects with any new arrhythmia (documented on ECG) requiring hospitalization, initiation of new long-term medical therapy (persisting > 45 days), or any post-index procedure cardioversion or intervention (pacemaker, ablation, etc.) in subjects without prior history of arrhythmia, as adjudicated by the Independent Data Review Board
measure: Number of Subjects With Wire Frame Fracture
time frame: 6 months
description: Among subjects with technical success, the number of subjects with wire frame fracture as determined by fluoroscopy at the 6-month evaluation.
arm group label: Device
arm group type: Experimental
description: ASD closure with the GORE® CARDIOFORM ASD Occluder
intervention type: Device
intervention name: GORE® CARDIOFORM ASD Occluder
description: Percutaneous Atrial Septal Defect Closure
arm group label: Device
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Robert Sommer, MD
role: Principal Investigator
affiliation: Columbia University of New York
last name: Matthew Gillespie, MD
role: Principal Investigator
affiliation: Children's Hospital of Philadelphia
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Heart Septal Defects
mesh term: Heart Septal Defects, Atrial
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 