<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/NCT01675596</url>
  </required_header>
  <id_info>
    <org_study_id>2011-14</org_study_id>
    <nct_id>NCT01675596</nct_id>
  </id_info>
  <brief_title>The SOLACE-AU Clinical Trial</brief_title>
  <acronym>SOLACE-AU</acronym>
  <official_title>A Multicentre, Non-Randomised Controlled Study of the Safety, Performance, Quality of Life and Cost Effectiveness Outcomes of the Edwards SAPIEN XT™ Transcatheter Heart Valve in an Australian Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Edwards Lifesciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pacific Clinical Research Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Edwards Lifesciences</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to observe the safety, efficacy and cost effectiveness of the&#xD;
      Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-centre, prospective, consecutively enrolled, non-randomized clinical trial.&#xD;
      The comparatator group will consist of subjects undergoing surgical aortic valve replacement&#xD;
      in Cohort A of the PARTNER II Trial [NCT01314313].&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2012</start_date>
  <completion_date type="Actual">August 8, 2018</completion_date>
  <primary_completion_date type="Actual">February 2016</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>VARC-2 Composite Safety Endpoint</measure>
    <time_frame>30 days</time_frame>
    <description>The primary endpoint is a VARC-2 Composite. It comprises 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 complications&#xD;
Valve related dysfunction (requiring repeat procedure)&#xD;
A composite endpoint is an endpoint that is a combination of multiple components.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All Cause Mortality</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All Cause Mortality</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">199</enrollment>
  <condition>Severe, Symptomatic Aortic Stenosis</condition>
  <arm_group>
    <arm_group_label>Test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SAPIEN XT™ valve with the NovaFlex and NovaFlex+ delivery systems.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TAVR Implantation of the Transcatheter Aortic Valve Prosthesis</intervention_name>
    <description>Operable subjects</description>
    <arm_group_label>Test</arm_group_label>
    <other_name>Implantation of the Transcatheter Aortic Valve Prosthesis</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 70 years&#xD;
&#xD;
          -  STS Score &gt; 4&#xD;
&#xD;
          -  Heart team agrees on eligibility including assessment that TAVR or AVR is appropriate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;70 years&#xD;
&#xD;
          -  Evidence of an acute myocardial infarction ≤ 30 days&#xD;
&#xD;
          -  Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is&#xD;
             non-calcified&#xD;
&#xD;
          -  Stroke or transient ischemic attack (TIA) within 6 months of the procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Owen Christopher Raffel</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Prince Charles Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Prince Alfred Hospital</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Macquarie Unversity Hospital</name>
      <address>
        <city>Macquarie Park</city>
        <state>New South Wales</state>
        <zip>2109</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Randwick</city>
        <state>New South Wales</state>
        <zip>2031</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal North Shore Hospital</name>
      <address>
        <city>St. Leonards</city>
        <state>New South Wales</state>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Prince Charles Hospital</name>
      <address>
        <city>Chermside</city>
        <state>Queensland</state>
        <zip>4032</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Flinders Medical Centre</name>
      <address>
        <city>Bedford Park</city>
        <state>South Australia</state>
        <zip>5042</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Alfred Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital - MELBOURNE</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Melbourne Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Perth Hospital/Fiona Stanley Hospital</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <results_first_submitted>February 15, 2019</results_first_submitted>
  <results_first_submitted_qc>March 25, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 16, 2019</results_first_posted>
  <last_update_submitted>March 25, 2019</last_update_submitted>
  <last_update_submitted_qc>March 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aortic Stenosis</keyword>
  <keyword>Transfemoral</keyword>
  <keyword>Transcatheter Heart Valve</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>TAVR With SAPIEN XT THV</title>
          <description>SAPIEN XT™ THV with the NovaFlex and NovaFlex+ delivery systems.&#xD;
TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="199">One patient did not receive the study device.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="191"/>
              </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>Death</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Exit with other reason</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missed Visit</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>TAVR With SAPIEN XT THV</title>
          <description>SAPIEN XT™ THV with the NovaFlex and NovaFlex+ delivery systems.&#xD;
TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="199"/>
          </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="85.5" spread="4.51"/>
                  </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="108"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>STS Score</title>
          <description>The Society of Thoracic Surgeons (STS) score measures patient risk at the time of cardiovascular surgery on a scale that ranges from 0% to 100%, with higher numbers indicating greater risk.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.9" spread="2.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>NYHA I/II</title>
          <description>New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>NYHA III/IV</title>
          <description>New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>VARC-2 Composite Safety Endpoint</title>
        <description>The primary endpoint is a VARC-2 Composite. It comprises 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 complications&#xD;
Valve related dysfunction (requiring repeat procedure)&#xD;
A composite endpoint is an endpoint that is a combination of multiple components.</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TAVR With SAPIEN XT THV</title>
            <description>SAPIEN XT™ THV with the NovaFlex and NovaFlex+ delivery systems.&#xD;
TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects</description>
          </group>
        </group_list>
        <measure>
          <title>VARC-2 Composite Safety Endpoint</title>
          <description>The primary endpoint is a VARC-2 Composite. It comprises 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 complications&#xD;
Valve related dysfunction (requiring repeat procedure)&#xD;
A composite endpoint is an endpoint that is a combination of multiple components.</description>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="199"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All Cause Mortality</title>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TAVR With SAPIEN XT THV</title>
            <description>SAPIEN XT™ THV with the NovaFlex and NovaFlex+ delivery systems.&#xD;
TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects</description>
          </group>
        </group_list>
        <measure>
          <title>All Cause Mortality</title>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="199"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All Cause Mortality</title>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TAVR With SAPIEN XT THV</title>
            <description>SAPIEN XT™ THV with the NovaFlex and NovaFlex+ delivery systems.&#xD;
TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects</description>
          </group>
        </group_list>
        <measure>
          <title>All Cause Mortality</title>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="199"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-Cause mortality for 12 months of follow-up post-implantation of device, Serious and other Adverse Events for 30-days post-implantation of device are presented.</time_frame>
      <desc>All Adverse Events are site-reported.</desc>
      <group_list>
        <group group_id="E1">
          <title>TAVR With SAPIEN XT THV</title>
          <description>SAPIEN XT™ THV with the NovaFlex and NovaFlex+ delivery systems.&#xD;
TAVR Implantation of the Transcatheter Aortic Valve Prosthesis: Operable subjects</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 10.0</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="17" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="73" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina/Cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Arrhythmia/Conduction system injury (defect)</sub_title>
                <counts group_id="E1" events="21" subjects_affected="17" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Cardiac tamponade/Pericardial effusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Heart failure/CHF/Low output failure</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastro Intestinal event - Non-hemorrhagic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection - Respiratory infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Infection - Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Access site and access related vascular injury - Dissection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Access site and access related vascular injury - Distal embolization (noncerebral)</sub_title>
                <description>Access site and access related vascular injury - Distal embolization (noncerebral) from vascular source</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Access site and access related vascular injury - Failure of percutaneous access site closure</sub_title>
                <description>Access site and access related vascular injury - Failure of percutaneous access site closure resulting in intervention</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Access site and access related vascular injury - Hematoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Access site and access related vascular injury - Pseudoaneurysm</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Access site and access related vascular injury - Rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Access site and access related vascular injury - Ventricular rupture (Apical rupture)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Device migration/malposition requiring intervention</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Embolization including air/calcific valve material or Thrombus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Abnormal lab value</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Miscellaneous - Other</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Multi organ failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Unknown cause of death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Other</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia/Hemolytic anemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neurological - Hemorrhagic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Neurological - Ischemic stroke</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Neurological - Other</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Neurological - Other new neurological sign consistent with stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Neurological - TIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental state change (not neurological) - Confusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal insufficiency or renal failure</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Genito-Urinary event - Non-hemorrhagic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory event - Aspiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Respiratory event - Dyspnea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Respiratory event - Other</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Respiratory event - Pulmonary edema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Respiratory event - Respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Bleeding - Hemorrhage</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 10.0</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="182" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal Labs</sub_title>
                <counts group_id="E1" events="15" subjects_affected="13" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia/Conduction system injury (defect)</sub_title>
                <counts group_id="E1" events="91" subjects_affected="65" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Miscellaneous - Other</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection - Respiratory infection</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Access site and access related vascular injury - Hematoma</sub_title>
                <counts group_id="E1" events="58" subjects_affected="51" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Other</sub_title>
                <counts group_id="E1" events="160" subjects_affected="100" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia/Hemolytic anemia</sub_title>
                <counts group_id="E1" events="21" subjects_affected="21" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal - Pain</sub_title>
                <counts group_id="E1" events="19" subjects_affected="18" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental state change (not neurological) - Confusion</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Genito-Urinary event - Non-hemorrhagic</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Renal insufficiency or renal failure</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="199"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Bleeding - Hemorrhage</sub_title>
                <counts group_id="E1" events="68" subjects_affected="58" subjects_at_risk="199"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="29" subjects_affected="28" subjects_at_risk="199"/>
              </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 NOT 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>Tenley Koepnick</name_or_title>
      <organization>Edwards Lifesciences</organization>
      <email>tenley.koepnick@edwards.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/NCT01675596
org study id: 2011-14
nct id: NCT01675596
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The objective of the study is to observe the safety, efficacy and cost effectiveness of the
      Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.
This is a multi-centre, prospective, consecutively enrolled, non-randomized clinical trial.
      The comparatator group will consist of subjects undergoing surgical aortic valve replacement
      in Cohort A of the PARTNER II Trial [NCT01314313].
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: VARC-2 Composite Safety Endpoint
time frame: 30 days
description: The primary endpoint is a VARC-2 Composite. It comprises 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 complications
Valve related dysfunction (requiring repeat procedure)
A composite endpoint is an endpoint that is a combination of multiple components.
measure: All Cause Mortality
time frame: 30 days
measure: All Cause Mortality
time frame: 12 months
arm group label: Test
arm group type: Experimental
description: SAPIEN XT™ valve with the NovaFlex and NovaFlex+ delivery systems.
intervention type: Device
intervention name: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
description: Operable subjects
arm group label: Test
other name: Implantation of the Transcatheter Aortic Valve Prosthesis
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Dr. Owen Christopher Raffel
role: Principal Investigator
affiliation: The Prince Charles Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 