<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/NCT01676727</url>
  </required_header>
  <id_info>
    <org_study_id>Advance-DA</org_study_id>
    <nct_id>NCT01676727</nct_id>
  </id_info>
  <brief_title>ADVANCE Direct Aortic Study</brief_title>
  <official_title>CoreValve® ADVANCE Direct Aortic Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Bakken Research Center</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Cardiovascular</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is intended to collect data regarding the clinical utility, safety and performance&#xD;
      of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in&#xD;
      patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic&#xD;
      access (DA) is selected.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is intended to collect data regarding the clinical utility, safety and performance&#xD;
      of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in&#xD;
      patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic&#xD;
      access (DA) is selected. As part of the study analysis, resource utilization together with&#xD;
      the Quality of Life questionnaires data will provide an important input into cost&#xD;
      effectiveness analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause Mortality</measure>
    <time_frame>30 days post-implant</time_frame>
    <description>Kaplan-Meier estimate of 30-day all-cause mortality.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)</measure>
    <time_frame>1, 6 and 12 months</time_frame>
    <description>The combined safety endpoint is defined as a composite of:&#xD;
All-cause mortality&#xD;
All stroke&#xD;
Life-threatening bleeding&#xD;
Acute kidney injury-Stage 3 (including renal replacement therapy)&#xD;
Coronary artery obstruction requiring intervention&#xD;
Major vascular complication&#xD;
Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)&#xD;
High degree AV block requiring permanent pacemaker implantation</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Aortic Stenosis</condition>
  <condition>Valvular Heart Disease</condition>
  <arm_group>
    <arm_group_label>CoreValve aortic valve</arm_group_label>
    <description>Implantation of CoreValve aortic valve via direct aortic approach</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CoreValve aortic valve</intervention_name>
    <description>Implantation of CoreValve aortic valve via direct aortic approach</description>
    <arm_group_label>CoreValve aortic valve</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with severe aortic stenosis who are scheduled for an elective transcatheter aortic&#xD;
        valve implantation and who are selected (e.g. because of an calcified femoral artery) to&#xD;
        receive the CoreValve® device via direct aortic access.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Severe symptomatic aortic valve stenosis requiring treatment&#xD;
&#xD;
          2. Acceptable candidate for elective treatment with the Medtronic CoreValve® System&#xD;
             according to the most recent version of the Medtronic CoreValve® Instructions For Use&#xD;
&#xD;
          3. 21 years of age or older&#xD;
&#xD;
          4. Patient is willing and able to comply with all protocol-specified follow-up&#xD;
             evaluations&#xD;
&#xD;
          5. The patient or legal representative has been informed of the nature of the study and&#xD;
             has consented to participate, and has authorized the collection and release of his/her&#xD;
             medical information by signing a consent form (&quot;Patient Informed Consent Form&quot;)&#xD;
&#xD;
          6. Patient will receive the CoreValve® device via direct aortic approach TAVI -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine,&#xD;
             clopidogrel, nitinol, or sensitivity to contrast media which cannot be adequately&#xD;
             pre-medicated&#xD;
&#xD;
          2. Sepsis, including active endocarditis&#xD;
&#xD;
          3. Recent myocardial infarction (&lt;30 days)&#xD;
&#xD;
          4. Left ventricular or atrial thrombus by echocardiography&#xD;
&#xD;
          5. Uncontrolled atrial fibrillation&#xD;
&#xD;
          6. Mitral or tricuspid valvular insufficiency (&gt;grade II)&#xD;
&#xD;
          7. Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve)&#xD;
&#xD;
          8. Evolutive or recent (within 6 months of implant procedure) cerebrovascular accident&#xD;
             (CVA) or transient ischemic attack (TIA)&#xD;
&#xD;
          9. Patients with:&#xD;
&#xD;
               1. Vascular conditions that make insertion and endovascular access to the aortic&#xD;
                  valve impossible, or&#xD;
&#xD;
               2. Symptomatic carotid or vertebral arterial narrowing (&gt;70%) disease, or&#xD;
&#xD;
               3. Thoracic aortic aneurysm in the path of delivery system&#xD;
&#xD;
         10. Bleeding diathesis or coagulopathy&#xD;
&#xD;
         11. Patient refuses blood transfusion&#xD;
&#xD;
         12. Estimated life expectancy of less than 12 months unless TAVI is performed&#xD;
&#xD;
         13. Creatine clearance &lt;20 mL/min&#xD;
&#xD;
         14. Active gastritis or peptic ulcer disease&#xD;
&#xD;
         15. Pregnancy or intent to become pregnant during study follow up&#xD;
&#xD;
         16. Patient is participating in another trial that may influence the results of this study&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neil Moat, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Royal Brompton Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Giuseppe Bruschi, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda spedaliera Niguarda Ca' Granda Milano</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nemocnice Podlesi Trinec</name>
      <address>
        <city>Trinec</city>
        <zip>739 61</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de Rangueil</name>
      <address>
        <city>Toulouse</city>
        <zip>31059 CEDEX 9</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Halle (Saale)</name>
      <address>
        <city>Halle (Saale)</city>
        <zip>06120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda spedaliera Spedali Civili Di Brescia</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda spedaliera Niguarda Ca' Granda Milano</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catharina Ziekenhuis</name>
      <address>
        <city>Eindhoven</city>
        <zip>5623 EJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch centrum Leeuwarden</name>
      <address>
        <city>Leeuwarden</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brighton and Sussex University Hospitals NHS Trust, Royal Sussex County Hospital</name>
      <address>
        <city>Brighton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brompton &amp; Harefield NHS Trust</name>
      <address>
        <city>London</city>
        <zip>SW3 6NP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>Norway</country>
    <country>Poland</country>
  </removed_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <results_first_submitted>September 6, 2016</results_first_submitted>
  <results_first_submitted_qc>October 27, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">July 30, 2018</results_first_posted>
  <last_update_submitted>August 20, 2018</last_update_submitted>
  <last_update_submitted_qc>August 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Transcatheter Aortic valve Implantation</keyword>
  <keyword>Heart Valve Diseases</keyword>
  <keyword>Cardiovascular Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Heart Valve Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>All Enrolled</title>
          <description>All subjects enrolled in the trial</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Implanted</title>
              <participants_list>
                <participants group_id="P1" count="92"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
              </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>Death</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Screening failure</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not willing to attend 1-year visit</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Valve explanted</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All enrolled population.</population>
      <group_list>
        <group group_id="B1">
          <title>All Enrolled</title>
          <description>All subjects enrolled in the trial</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81.9" spread="5.9"/>
                  </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="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                  </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>Czech Republic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>All-cause Mortality</title>
        <description>Kaplan-Meier estimate of 30-day all-cause mortality.</description>
        <time_frame>30 days post-implant</time_frame>
        <population>all subjects who underwent an attempted implant of whom all were implanted with the CoreValve device via the direct aortic approach</population>
        <group_list>
          <group group_id="O1">
            <title>Implanted Population</title>
            <description>All subjects who were implanted with the CoreValve.</description>
          </group>
        </group_list>
        <measure>
          <title>All-cause Mortality</title>
          <description>Kaplan-Meier estimate of 30-day all-cause mortality.</description>
          <population>all subjects who underwent an attempted implant of whom all were implanted with the CoreValve device via the direct aortic approach</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" lower_limit="1.4" upper_limit="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)</title>
        <description>The combined safety endpoint is defined as a composite of:&#xD;
All-cause mortality&#xD;
All stroke&#xD;
Life-threatening bleeding&#xD;
Acute kidney injury-Stage 3 (including renal replacement therapy)&#xD;
Coronary artery obstruction requiring intervention&#xD;
Major vascular complication&#xD;
Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)&#xD;
High degree AV block requiring permanent pacemaker implantation</description>
        <time_frame>1, 6 and 12 months</time_frame>
        <population>all subjects who underwent an attempted implant of whom all were implanted with the CoreValve device via the direct aortic approach</population>
        <group_list>
          <group group_id="O1">
            <title>Implanted Population</title>
            <description>All subjects who were implanted with the CoreValve</description>
          </group>
        </group_list>
        <measure>
          <title>Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)</title>
          <description>The combined safety endpoint is defined as a composite of:&#xD;
All-cause mortality&#xD;
All stroke&#xD;
Life-threatening bleeding&#xD;
Acute kidney injury-Stage 3 (including renal replacement therapy)&#xD;
Coronary artery obstruction requiring intervention&#xD;
Major vascular complication&#xD;
Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)&#xD;
High degree AV block requiring permanent pacemaker implantation</description>
          <population>all subjects who underwent an attempted implant of whom all were implanted with the CoreValve device via the direct aortic approach</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1 month</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" lower_limit="3.4" upper_limit="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.6" lower_limit="10.6" upper_limit="26.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.9" lower_limit="11.7" upper_limit="29.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected up to 1 year post-implant procedure.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Implanted Population</title>
          <description>all subjects who underwent an attempted implant of whom all were implanted with the CoreValve device via the direct aortic approach</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="72" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>New or worsened conduction disturbances and arrhythmias without pacemaker implant</sub_title>
                <counts group_id="E1" events="13" subjects_affected="11" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Failure of current therapy for AS requiring hospitalization or worsening congestive heart failure</sub_title>
                <counts group_id="E1" events="13" subjects_affected="10" subjects_at_risk="92"/>
              </event>
              <event>
                <description>Adverse events not associated with the use of the study device were collected without a specific adverse event term</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <description>Adverse events not associated with the use of the study device were collected without a specific adverse event term</description>
                <counts group_id="E1" events="103" subjects_affected="55" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <description>Adverse events not associated with the use of the study device were collected without a specific adverse event term</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Vascular access site and access-related complications</sub_title>
                <counts group_id="E1" events="17" subjects_affected="15" subjects_at_risk="92"/>
              </event>
              <event>
                <description>Adverse events not associated with the use of the study device were collected without a specific adverse event term</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Permanent Pacemaker Implantation</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Sternotomy or thoracotomy related event</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Stroke-TIA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="92"/>
              </event>
              <event>
                <sub_title>Bleeding</sub_title>
                <counts group_id="E1" events="34" subjects_affected="24" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="68" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <description>Adverse events not associated with the use of the study device were collected without a specific adverse event term</description>
                <counts group_id="E1" events="38" subjects_affected="31" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <description>Adverse events not associated with the use of the study device were collected without a specific adverse event term</description>
                <counts group_id="E1" events="93" subjects_affected="51" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <description>Adverse events not associated with the use of the study device were collected without a specific adverse event term</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <description>Adverse events not associated with the use of the study device were collected without a specific adverse event term</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <description>Adverse events not associated with the use of the study device were collected without a specific adverse event term</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <description>Adverse events not associated with the use of the study device were collected without a specific adverse event term</description>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <description>Adverse events not associated with the use of the study device were collected without a specific adverse event term</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="92"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <description>Adverse events not associated with the use of the study device were collected without a specific adverse event term</description>
                <counts group_id="E1" events="15" subjects_affected="14" subjects_at_risk="92"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Maarten Hollander</name_or_title>
      <organization>Medtronic Bakken Research Center</organization>
      <phone>+31620534428</phone>
      <email>Maarten.Hollander@medtronic.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/NCT01676727
org study id: Advance-DA
nct id: NCT01676727
lead sponsor: 
has dmc: No
This study is intended to collect data regarding the clinical utility, safety and performance
      of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in
      patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic
      access (DA) is selected.
This study is intended to collect data regarding the clinical utility, safety and performance
      of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in
      patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic
      access (DA) is selected. As part of the study analysis, resource utilization together with
      the Quality of Life questionnaires data will provide an important input into cost
      effectiveness analysis.
observational model: Cohort
time perspective: Prospective
measure: All-cause Mortality
time frame: 30 days post-implant
description: Kaplan-Meier estimate of 30-day all-cause mortality.
measure: Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
time frame: 1, 6 and 12 months
description: The combined safety endpoint is defined as a composite of:
All-cause mortality
All stroke
Life-threatening bleeding
Acute kidney injury-Stage 3 (including renal replacement therapy)
Coronary artery obstruction requiring intervention
Major vascular complication
Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)
High degree AV block requiring permanent pacemaker implantation
arm group label: CoreValve aortic valve
description: Implantation of CoreValve aortic valve via direct aortic approach
intervention type: Device
intervention name: CoreValve aortic valve
description: Implantation of CoreValve aortic valve via direct aortic approach
arm group label: CoreValve aortic valve
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Neil Moat, M.D.
role: Principal Investigator
affiliation: The Royal Brompton Hospital
last name: Giuseppe Bruschi, M.D.
role: Principal Investigator
affiliation: Azienda spedaliera Niguarda Ca' Granda Milano
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Czechia
country: France
country: Germany
country: Italy
country: Netherlands
country: United Kingdom
country: Czech Republic
country: Norway
country: Poland
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Aortic Valve Stenosis
mesh term: Heart Valve Diseases
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 