<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/NCT02184442</url>
  </required_header>
  <id_info>
    <org_study_id>2010-12-PIIB</org_study_id>
    <nct_id>NCT02184442</nct_id>
  </id_info>
  <brief_title>The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B</brief_title>
  <acronym>PARTNERII B</acronym>
  <official_title>The PARTNER II Trial &quot;Placement of AoRTic TraNscathetER&quot; Valves Trial&quot; (US) [PII B] for Inoperable Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Edwards Lifesciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American College of Cardiology</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV&#xD;
      with the associated delivery system for inoperable patients with severe symptomatic native&#xD;
      aortic stenosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cohort B was a 1:1 randomized, controlled study independently powered to compare&#xD;
      transcatheter heart valve therapy with the first generation (SAPIEN™ THV) system to&#xD;
      transcatheter heart valve therapy with the second generation (SAPIEN XT THV) system in&#xD;
      patients who could not undergo surgery (inoperable).&#xD;
&#xD;
      Patients in the control arm of Cohort B received an Edwards SAPIEN THV with the associated&#xD;
      delivery system while patients in the treatment arm of Cohort B received an Edwards SAPIEN XT&#xD;
      THV with the associated delivery system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 9, 2011</start_date>
  <completion_date type="Actual">May 30, 2017</completion_date>
  <primary_completion_date type="Actual">May 1, 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization</measure>
    <time_frame>1 Year</time_frame>
    <description>All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NYHA Classification - Change From Baseline</measure>
    <time_frame>Baseline and 1 Year</time_frame>
    <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>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Aortic Regurgitation - Change From Baseline</measure>
    <time_frame>1 Year</time_frame>
    <description>Total aortic regurgitation was assessed by the core lab as 'Grade 0' = None, 'Grade 1+' = Trace, 'Grade 2+' = Mild, 'Grade 3+' = Moderate, and 'Grade 4+' = Severe.&#xD;
Total regurgitation at one year was analyzed in the valve implant population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effective Orifice Area - Change From Baseline</measure>
    <time_frame>1 Year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">560</enrollment>
  <condition>Severe</condition>
  <condition>Symptomatic</condition>
  <condition>Calcific Aortic Stenosis</condition>
  <arm_group>
    <arm_group_label>TAVR - SAPIEN XT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAVR (transaortic valve replacement) with SAPIEN XT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAVR - SAPIEN</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TAVR (transaortic valve replacement) with SAPIEN is the control arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TAVR Implantation with SAPIEN XT</intervention_name>
    <description>Inoperable operable patients requiring the transcatheter aortic heart valve replacement</description>
    <arm_group_label>TAVR - SAPIEN XT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TAVR Implantation with SAPIEN</intervention_name>
    <description>Inoperable operable patients requiring the transcatheter aortic heart valve replacement</description>
    <arm_group_label>TAVR - SAPIEN</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA&#xD;
             Functional Class II or greater.&#xD;
&#xD;
          2. The probability of death or serious, irreversible morbidity is greater than or equal&#xD;
             to 50%.&#xD;
&#xD;
          3. The heart team agreed (and verified in the case review process) that valve&#xD;
             implantation would likely benefit the patient.&#xD;
&#xD;
          4. The study patient or the study patient's legal representative was informed of the&#xD;
             nature of the study, agreed to its provisions and had provided written informed&#xD;
             consent as approved by the Institutional Review Board (IRB) of the respective clinical&#xD;
             site.&#xD;
&#xD;
          5. The study patient agreed to comply with all required post-procedure follow-up visits&#xD;
             including annual visits through 5 years and analysis close date visits, which was&#xD;
             conducted as a phone follow-up.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is&#xD;
             non-calcified.&#xD;
&#xD;
          2. Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch&#xD;
             atheroma [especially if thick (&gt; 5 mm), protruding or ulcerated] or narrowing&#xD;
             (especially with calcification and surface irregularities) of the abdominal or&#xD;
             thoracic aorta, severe &quot;unfolding&quot; and tortuosity of the thoracic aorta.&#xD;
             (Transfemoral)&#xD;
&#xD;
          3. Currently participating in an investigational drug or another device study. Note:&#xD;
             Trials requiring extended follow-up for products that were investigational, but have&#xD;
             since become commercially available, are not considered investigational trials.&#xD;
&#xD;
          4. It is known that the patient is currently enrolled in the PARTNER I Trial or was&#xD;
             withdrawn from the PARTNER I Trial prior to endpoint analysis.&#xD;
&#xD;
          5. Active bacterial endocarditis within 6 months (180 days) of procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin B Leon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arkansas Heart Hospital/Clinic</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scripps Green Hospital</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scripps Memorial Hospital</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy General Hospital</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University Medical Center</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Hospital Center (WHC)</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morton Plant Hospital</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida, Gainesville</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prairie Education and Research Cooperative</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University Health-Methodist Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville - Jewish Hospital</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</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>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Beaumont Hospital</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis Heart Institute Foundation</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Hospital of Kansas City Mid America</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University - Barnes Jewish Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Heart Institute</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newark Beth Israel</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore University Hospital, NY</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winthrop University Hospital</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cornell University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina Charleston</name>
      <address>
        <city>Charleston</city>
        <state>North Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Carolina Heart Institute at East Carolina University</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christ Hospital, Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</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>Oklahoma Heart Hospital</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>York Hospital</name>
      <address>
        <city>York</city>
        <state>Pennsylvania</state>
        <zip>17403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Memorial Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Heart, PLLC</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Heart Hospital Baylor Plano</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical City Dallas Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at San Antonio (UTHSCSA)</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229-3900</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara Norfolk General Hospital</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin - Madison</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>January 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <results_first_submitted>December 7, 2017</results_first_submitted>
  <results_first_submitted_qc>July 17, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 14, 2018</results_first_posted>
  <last_update_submitted>August 27, 2018</last_update_submitted>
  <last_update_submitted_qc>August 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SAPIEN</keyword>
  <keyword>TAVR</keyword>
  <keyword>THV</keyword>
  <keyword>Aortic Stenosis</keyword>
  <keyword>Heart Valve Disease</keyword>
  <keyword>Aortic Valve</keyword>
  <keyword>Retroflex</keyword>
  <keyword>SAPIEN XT</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>
      <recruitment_details>Subjects were screened and enrolled at 53 sites in the US and Canada</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>TAVR - SAPIEN XT</title>
          <description>TAVR (transaortic valve replacement) with SAPIEN XT&#xD;
TAVR Implantation with SAPIEN XT: Inoperable operable patients requiring the transcatheter aortic heart valve replacement</description>
        </group>
        <group group_id="P2">
          <title>TAVR - SAPIEN</title>
          <description>TAVR (transaortic valve replacement) with SAPIEN is the control arm&#xD;
TAVR Implantation with SAPIEN: Inoperable operable patients requiring the transcatheter aortic heart valve replacement</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="284"/>
                <participants group_id="P2" count="276"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>As-Treated</title>
              <participants_list>
                <participants group_id="P1" count="282"/>
                <participants group_id="P2" count="271"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Valve-Implant</title>
              <participants_list>
                <participants group_id="P1" count="280"/>
                <participants group_id="P2" count="263"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="220"/>
                <participants group_id="P2" count="200"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="64"/>
                <participants group_id="P2" count="76"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="61"/>
                <participants group_id="P2" count="65"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>TAVR - SAPIEN XT</title>
          <description>TAVR (transaortic valve replacement) with SAPIEN XT&#xD;
TAVR Implantation with SAPIEN XT: Inoperable operable patients requiring the transcatheter aortic heart valve replacement</description>
        </group>
        <group group_id="B2">
          <title>TAVR - SAPIEN</title>
          <description>TAVR (transaortic valve replacement) with SAPIEN is the control arm&#xD;
TAVR Implantation with SAPIEN: Inoperable operable patients requiring the transcatheter aortic heart valve replacement</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="284"/>
            <count group_id="B2" value="276"/>
            <count group_id="B3" value="560"/>
          </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="84.0" spread="8.65"/>
                    <measurement group_id="B2" value="84.6" spread="8.61"/>
                    <measurement group_id="B3" value="84.3" spread="8.63"/>
                  </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="143"/>
                    <measurement group_id="B2" value="134"/>
                    <measurement group_id="B3" value="277"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="141"/>
                    <measurement group_id="B2" value="142"/>
                    <measurement group_id="B3" value="283"/>
                  </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 of mortality and morbidity 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="10.3" spread="5.38"/>
                    <measurement group_id="B2" value="11.0" spread="5.71"/>
                    <measurement group_id="B3" value="10.6" spread="5.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>NYHA Class 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="275"/>
                    <measurement group_id="B2" value="265"/>
                    <measurement group_id="B3" value="540"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Coronary Artery Disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="186"/>
                    <measurement group_id="B2" value="186"/>
                    <measurement group_id="B3" value="372"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Frailty</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="168"/>
                    <measurement group_id="B2" value="166"/>
                    <measurement group_id="B3" value="334"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization</title>
        <description>All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year</description>
        <time_frame>1 Year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TAVR - SAPIEN XT</title>
            <description>TAVR (transaortic valve replacement) with SAPIEN XT&#xD;
TAVR Implantation with SAPIEN XT: Inoperable operable patients requiring the transcatheter aortic heart valve replacement</description>
          </group>
          <group group_id="O2">
            <title>TAVR - SAPIEN</title>
            <description>TAVR (transaortic valve replacement) with SAPIEN is the control arm&#xD;
TAVR Implantation with SAPIEN: Inoperable operable patients requiring the transcatheter aortic heart valve replacement</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization</title>
          <description>All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="284"/>
                <count group_id="O2" value="276"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105"/>
                    <measurement group_id="O2" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>NYHA Classification - Change From Baseline</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>
        <time_frame>Baseline and 1 Year</time_frame>
        <population>Please note that all the patients were not available for a NYHA functional assessment</population>
        <group_list>
          <group group_id="O1">
            <title>TAVR - SAPIEN XT</title>
            <description>TAVR (transaortic valve replacement) with SAPIEN XT&#xD;
TAVR Implantation with SAPIEN XT: Inoperable operable patients requiring the transcatheter aortic heart valve replacement</description>
          </group>
          <group group_id="O2">
            <title>TAVR - SAPIEN</title>
            <description>TAVR (transaortic valve replacement) with SAPIEN is the control arm&#xD;
TAVR Implantation with SAPIEN: Inoperable operable patients requiring the transcatheter aortic heart valve replacement</description>
          </group>
        </group_list>
        <measure>
          <title>NYHA Classification - Change From Baseline</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>
          <population>Please note that all the patients were not available for a NYHA functional assessment</population>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="204"/>
                <count group_id="O2" value="192"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="0.92"/>
                    <measurement group_id="O2" value="-1.7" spread="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Aortic Regurgitation - Change From Baseline</title>
        <description>Total aortic regurgitation was assessed by the core lab as 'Grade 0' = None, 'Grade 1+' = Trace, 'Grade 2+' = Mild, 'Grade 3+' = Moderate, and 'Grade 4+' = Severe.&#xD;
Total regurgitation at one year was analyzed in the valve implant population.</description>
        <time_frame>1 Year</time_frame>
        <population>Please note that all the valve-implant population do not have echo data.</population>
        <group_list>
          <group group_id="O1">
            <title>TAVR - SAPIEN XT</title>
            <description>TAVR (transaortic valve replacement) with SAPIEN XT&#xD;
TAVR Implantation with SAPIEN XT: Inoperable operable patients requiring the transcatheter aortic heart valve replacement</description>
          </group>
          <group group_id="O2">
            <title>TAVR - SAPIEN</title>
            <description>TAVR (transaortic valve replacement) with SAPIEN is the control arm&#xD;
TAVR Implantation with SAPIEN: Inoperable operable patients requiring the transcatheter aortic heart valve replacement</description>
          </group>
        </group_list>
        <measure>
          <title>Total Aortic Regurgitation - Change From Baseline</title>
          <description>Total aortic regurgitation was assessed by the core lab as 'Grade 0' = None, 'Grade 1+' = Trace, 'Grade 2+' = Mild, 'Grade 3+' = Moderate, and 'Grade 4+' = Severe.&#xD;
Total regurgitation at one year was analyzed in the valve implant population.</description>
          <population>Please note that all the valve-implant population do not have echo data.</population>
          <units>Grade</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
                <count group_id="O2" value="155"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="1.38"/>
                    <measurement group_id="O2" value="0.1" spread="1.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effective Orifice Area - Change From Baseline</title>
        <time_frame>1 Year</time_frame>
        <population>Valve Implant Population; Please note that echo data was not available for all patients.</population>
        <group_list>
          <group group_id="O1">
            <title>TAVR - SAPIEN XT</title>
            <description>TAVR (transaortic valve replacement) with SAPIEN XT&#xD;
TAVR Implantation with SAPIEN XT: Inoperable operable patients requiring the transcatheter aortic heart valve replacement</description>
          </group>
          <group group_id="O2">
            <title>TAVR - SAPIEN</title>
            <description>TAVR (transaortic valve replacement) with SAPIEN is the control arm&#xD;
TAVR Implantation with SAPIEN: Inoperable operable patients requiring the transcatheter aortic heart valve replacement</description>
          </group>
        </group_list>
        <measure>
          <title>Effective Orifice Area - Change From Baseline</title>
          <population>Valve Implant Population; Please note that echo data was not available for all patients.</population>
          <units>cm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="149"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.41"/>
                    <measurement group_id="O2" value="0.9" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock.</time_frame>
      <desc>All adverse events are site reported&#xD;
Only Valve-Implanted patients are reported for all adverse events (except for mortality).</desc>
      <group_list>
        <group group_id="E1">
          <title>TAVR - SAPIEN XT</title>
          <description>TAVR (transaortic valve replacement) with SAPIEN XT&#xD;
TAVR Implantation with SAPIEN XT: Inoperable operable patients requiring the transcatheter aortic heart valve replacement</description>
        </group>
        <group group_id="E2">
          <title>TAVR - SAPIEN</title>
          <description>TAVR (transaortic valve replacement) with SAPIEN is the control arm&#xD;
TAVR Implantation with SAPIEN: Inoperable operable patients requiring the transcatheter aortic heart valve replacement</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="10" subjects_at_risk="282"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="271"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="196" subjects_at_risk="280"/>
                <counts group_id="E2" subjects_affected="180" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="280"/>
                <counts group_id="E2" events="16" subjects_affected="14" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="37" subjects_affected="33" subjects_at_risk="280"/>
                <counts group_id="E2" events="31" subjects_affected="30" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="280"/>
                <counts group_id="E2" events="19" subjects_affected="17" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Cardiac Tamponade/Pericardial Effusion</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="280"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Cardiogenic Shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Heart Failure / CHF / Low output Failure</sub_title>
                <counts group_id="E1" events="64" subjects_affected="46" subjects_at_risk="280"/>
                <counts group_id="E2" events="58" subjects_affected="39" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Mitral Valve Injury or Insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Non Structural Dysfunction</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="280"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Stenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="280"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Ventricular rupture (Apical rupture)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastro Intestinal Event</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="280"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Gastro Intestinal Event Nonhemorrhagic</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="280"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Coronary Flow Obstruction/Transvalvular flow disturbance</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Device Embolization</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Device Migration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Edema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Exercise intolerance or weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Multi Organ Failure</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Other</sub_title>
                <counts group_id="E1" events="56" subjects_affected="45" subjects_at_risk="280"/>
                <counts group_id="E2" events="52" subjects_affected="42" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="280"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Structural Dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Unknown cause of Death</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="280"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Access site infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="280"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Bacteremia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="280"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Respiratory Infection</sub_title>
                <counts group_id="E1" events="25" subjects_affected="22" subjects_at_risk="280"/>
                <counts group_id="E2" events="18" subjects_affected="17" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="15" subjects_affected="14" subjects_at_risk="280"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="280"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Failure of percutaneous access site closure resulting in intervention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="280"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Abnormal lab value</sub_title>
                <counts group_id="E1" events="13" subjects_affected="11" subjects_at_risk="280"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" events="12" subjects_affected="9" subjects_at_risk="280"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Hemiplegia (One side limb weakness)</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cancer</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysphasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Hemiparesis (One sided body weakness)</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Hemiplegia (One side limb weakness)</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Hemorrhagic Stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Ischemic Stroke</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="280"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Undetermined Stroke</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="280"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Change in level of consciousness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Cognitive Impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="280"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Dementia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Genito Urinary Event</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Genito Urinary Event Nonhemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Renal Insufficiency or Renal Failure</sub_title>
                <counts group_id="E1" events="18" subjects_affected="16" subjects_at_risk="280"/>
                <counts group_id="E2" events="16" subjects_affected="13" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="280"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Pulmonary Edema</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="280"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Pulmonary Effusion</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="280"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" events="16" subjects_affected="15" subjects_at_risk="280"/>
                <counts group_id="E2" events="17" subjects_affected="15" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic root rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Dissection</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="280"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Distal embolization from vascular source</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="280"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Embolization including air/calcific valve material or Thrombus</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="280"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="280"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Hemorrhage</sub_title>
                <counts group_id="E1" events="41" subjects_affected="37" subjects_at_risk="280"/>
                <counts group_id="E2" events="35" subjects_affected="30" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="280"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="280"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Ischemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="280"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Perforation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="280"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Pseudoaneurysm</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="280"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="280"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>TIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Thoracic aortic dissection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="263"/>
              </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="211" subjects_at_risk="280"/>
                <counts group_id="E2" subjects_affected="195" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia/Hemolytic Anemia</sub_title>
                <counts group_id="E1" events="45" subjects_affected="35" subjects_at_risk="280"/>
                <counts group_id="E2" events="39" subjects_affected="36" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="17" subjects_affected="16" subjects_at_risk="280"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="263"/>
              </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="52" subjects_affected="46" subjects_at_risk="280"/>
                <counts group_id="E2" events="51" subjects_affected="41" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Edema</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="280"/>
                <counts group_id="E2" events="19" subjects_affected="18" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastro Intestinal Event</sub_title>
                <counts group_id="E1" events="21" subjects_affected="19" subjects_at_risk="280"/>
                <counts group_id="E2" events="22" subjects_affected="19" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Other</sub_title>
                <counts group_id="E1" events="105" subjects_affected="79" subjects_at_risk="280"/>
                <counts group_id="E2" events="145" subjects_affected="87" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="280"/>
                <counts group_id="E2" events="21" subjects_affected="19" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Non Structural Dysfunction</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="280"/>
                <counts group_id="E2" events="16" subjects_affected="15" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Abnormal Lab Value</sub_title>
                <counts group_id="E1" events="75" subjects_affected="49" subjects_at_risk="280"/>
                <counts group_id="E2" events="77" subjects_affected="52" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="280"/>
                <counts group_id="E2" events="18" subjects_affected="16" subjects_at_risk="263"/>
              </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="23" subjects_affected="22" subjects_at_risk="280"/>
                <counts group_id="E2" events="16" subjects_affected="14" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="31" subjects_affected="28" subjects_at_risk="280"/>
                <counts group_id="E2" events="45" subjects_affected="35" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary Effusion</sub_title>
                <counts group_id="E1" events="29" subjects_affected="25" subjects_at_risk="280"/>
                <counts group_id="E2" events="21" subjects_affected="18" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Respiratory Infection</sub_title>
                <counts group_id="E1" events="17" subjects_affected="14" subjects_at_risk="280"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hemorrhage</sub_title>
                <counts group_id="E1" events="33" subjects_affected="28" subjects_at_risk="280"/>
                <counts group_id="E2" events="34" subjects_affected="30" subjects_at_risk="263"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="280"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="263"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Tenley Koepnick</name_or_title>
      <organization>Edwards Life Sciences</organization>
      <phone>949-250-6504</phone>
      <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/NCT02184442
org study id: 2010-12-PIIB
nct id: NCT02184442
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV
      with the associated delivery system for inoperable patients with severe symptomatic native
      aortic stenosis.
Cohort B was a 1:1 randomized, controlled study independently powered to compare
      transcatheter heart valve therapy with the first generation (SAPIEN™ THV) system to
      transcatheter heart valve therapy with the second generation (SAPIEN XT THV) system in
      patients who could not undergo surgery (inoperable).

      Patients in the control arm of Cohort B received an Edwards SAPIEN THV with the associated
      delivery system while patients in the treatment arm of Cohort B received an Edwards SAPIEN XT
      THV with the associated delivery system.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization
time frame: 1 Year
description: All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year
measure: NYHA Classification - Change From Baseline
time frame: Baseline and 1 Year
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.
measure: Total Aortic Regurgitation - Change From Baseline
time frame: 1 Year
description: Total aortic regurgitation was assessed by the core lab as 'Grade 0' = None, 'Grade 1+' = Trace, 'Grade 2+' = Mild, 'Grade 3+' = Moderate, and 'Grade 4+' = Severe.
Total regurgitation at one year was analyzed in the valve implant population.
measure: Effective Orifice Area - Change From Baseline
time frame: 1 Year
arm group label: TAVR - SAPIEN XT
arm group type: Experimental
description: TAVR (transaortic valve replacement) with SAPIEN XT
arm group label: TAVR - SAPIEN
arm group type: Active Comparator
description: TAVR (transaortic valve replacement) with SAPIEN is the control arm
intervention type: Device
intervention name: TAVR Implantation with SAPIEN XT
description: Inoperable operable patients requiring the transcatheter aortic heart valve replacement
arm group label: TAVR - SAPIEN XT
intervention type: Device
intervention name: TAVR Implantation with SAPIEN
description: Inoperable operable patients requiring the transcatheter aortic heart valve replacement
arm group label: TAVR - SAPIEN
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Martin B Leon, MD
role: Principal Investigator
affiliation: Columbia University
facility: 
facility: 
facility: 
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
sharing ipd: No
participant flow: 
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