<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/NCT03003299</url>
  </required_header>
  <id_info>
    <org_study_id>2015-08 AVIV</org_study_id>
    <nct_id>NCT03003299</nct_id>
  </id_info>
  <brief_title>PARTNER 3 Trial - Aortic Valve-in-Valve</brief_title>
  <official_title>A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Edwards Lifesciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </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>
      This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra&#xD;
      transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, single-arm, multicenter study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 5, 2017</start_date>
  <completion_date type="Anticipated">April 2038</completion_date>
  <primary_completion_date type="Anticipated">January 2033</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>Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke</measure>
    <time_frame>1 year</time_frame>
    <description>Number of patients that died and/or had a stroke</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean gradient</measure>
    <time_frame>30 days</time_frame>
    <description>Measures the mean aortic pressure gradient from the measured velocity. Units used are mmHg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak gradient</measure>
    <time_frame>30 days</time_frame>
    <description>Measures the peak aortic pressure gradient from the measured velocity. Units used are mmHg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kansas City Cardiomyopathy Questionnaire (KCCQ)</measure>
    <time_frame>30 days</time_frame>
    <description>Change from baseline in KCCQ. The KCCQ is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New York Heart Association (NYHA) Classification</measure>
    <time_frame>30 days</time_frame>
    <description>Change from baseline in NYHA. NYHA is a 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 (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six-Minute Walk Test (6MWT)</measure>
    <time_frame>30 days</time_frame>
    <description>Change from baseline in 6MWT. The 6-Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">125</enrollment>
  <condition>Aortic Stenosis</condition>
  <condition>Aortic Stenosis, Severe</condition>
  <arm_group>
    <arm_group_label>TAVR - Failing surgical or transcatheter valve</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with a failing surgical or transcatheter bioprosthetic valve will undergo transcatheter aortic valve replacement (TAVR).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Edwards SAPIEN 3/SAPIEN 3 Ultra THV</intervention_name>
    <description>Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.</description>
    <arm_group_label>TAVR - Failing surgical or transcatheter valve</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Failing surgical or transcatheter bioprosthetic valve in the aortic position&#xD;
             demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.&#xD;
&#xD;
          2. Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.&#xD;
&#xD;
          3. NYHA Functional Class ≥ II.&#xD;
&#xD;
          4. Heart Team agrees the patient is low to intermediate risk.&#xD;
&#xD;
          5. Heart Team agrees valve implantation will likely benefit the patient.&#xD;
&#xD;
          6. The study patient has been informed of the nature of the study, agrees to its&#xD;
             provisions and has provided written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Surgical or transcatheter valve in the mitral position (mitral rings are not an&#xD;
             exclusion)&#xD;
&#xD;
          2. Severe regurgitation (&gt; 3+) or stenosis of any other valve&#xD;
&#xD;
          3. Failing valve has moderate or severe paravalvular regurgitation&#xD;
&#xD;
          4. Failing valve is unstable, rocking, or not structurally intact&#xD;
&#xD;
          5. Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.&#xD;
&#xD;
          6. Increased risk of embolization of THV&#xD;
&#xD;
          7. Known bioprosthetic valve with residual mean gradient &gt; 20 mmHg at the end of the&#xD;
             index procedure for implantation of the original valve&#xD;
&#xD;
          8. Iliofemoral vessel characteristics that would preclude safe placement of the&#xD;
             introducer sheath (Transfemoral)&#xD;
&#xD;
          9. Anatomical characteristics that would preclude safe access to the ascending aorta&#xD;
             (Transaortic)&#xD;
&#xD;
         10. Anatomical characteristics that would preclude safe access to the apex (Transapical)&#xD;
&#xD;
         11. Evidence of an acute myocardial infarction ≤ 30 days before enrollment&#xD;
&#xD;
         12. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is&#xD;
             performed within 30 days prior to the index procedure. Implantation of a permanent&#xD;
             pacemaker or implantable cardioverter defibrillator is not considered an exclusion.&#xD;
&#xD;
         13. Patients with planned concomitant surgical or transcatheter ablation for Atrial&#xD;
             Fibrillation&#xD;
&#xD;
         14. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or&#xD;
             hypercoagulable states&#xD;
&#xD;
         15. Untreated clinically significant coronary artery disease requiring revascularization&#xD;
&#xD;
         16. Hemodynamic or respiratory instability requiring inotropic support, mechanical&#xD;
             ventilation, or mechanical heart assistance within 30 days of enrollment&#xD;
&#xD;
         17. Emergency interventional/surgical procedures within 30 days prior to the procedure&#xD;
&#xD;
         18. Any planned surgical, percutaneous coronary, or peripheral procedure to be performed&#xD;
             within the 30-day follow-up from the procedure&#xD;
&#xD;
         19. Hypertrophic cardiomyopathy with obstruction&#xD;
&#xD;
         20. LVEF &lt; 30%&#xD;
&#xD;
         21. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation&#xD;
&#xD;
         22. Inability to tolerate or condition precluding treatment with&#xD;
             antithrombotic/anticoagulation therapy during or after the valve implant procedure&#xD;
&#xD;
         23. Absolute contraindications or allergy to iodinated contrast that cannot be adequately&#xD;
             treated with premedication&#xD;
&#xD;
         24. Stroke or transient ischemic attack within 90 days of enrollment&#xD;
&#xD;
         25. Symptomatic carotid or vertebral artery disease or successful treatment of carotid&#xD;
             stenosis within 30 days of enrollment&#xD;
&#xD;
         26. Renal insufficiency and/or renal replacement therapy at the time of screening&#xD;
&#xD;
         27. Active bacterial endocarditis within 180 days of the procedure&#xD;
&#xD;
         28. Patient refuses blood products&#xD;
&#xD;
         29. Estimated life expectancy &lt; 24 months&#xD;
&#xD;
         30. Positive urine or serum pregnancy test in female subjects of childbearing potential&#xD;
&#xD;
         31. Currently participating in an investigational drug or another device study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chris S Malaisrie, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University Feinberg School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alan Zajarias, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mayra Guerrero, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Edwards THV Clinical Affairs</last_name>
    <phone>(949) 250-2500</phone>
    <email>THV_CT.gov@Edwards.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Banner University Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of California Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sutter Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95919</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </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>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UC Health Northern Colorado/Medical Center of the Rockies</name>
      <address>
        <city>Loveland</city>
        <state>Colorado</state>
        <zip>80538</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hartford Hospital</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>JFK Medical Center/ Atlantic Clinical Research Collaborative</name>
      <address>
        <city>Atlantis</city>
        <state>Florida</state>
        <zip>33462</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </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>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Northwestern University Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </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>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Northshore University HealthSystem</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </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>
    <status>Withdrawn</status>
  </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>
    <status>Recruiting</status>
  </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>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </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>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of Minnesota Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </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>
    <status>Withdrawn</status>
  </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>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nebraska Heart Institute</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68526</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </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>
    <status>Withdrawn</status>
  </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>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </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>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>New York University (NYU) Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </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>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center/ New York Presbyterian Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Carolina's Health System</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>NC Heart and Vascular (Rex Hospital)</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>The Christ Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Oklahoma Cardiovascular Research Group</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Providence Heart &amp; Vascular Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </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>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Allegheny General Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Lankenau Medical Center</name>
      <address>
        <city>Wynnewood</city>
        <state>Pennsylvania</state>
        <zip>19096</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Baptist Memorial Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Saint Thomas Health Services</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Austin Heart, PLLC</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78756</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Medical City Dallas Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </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>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Inova Heart and vascular Instritute (Fairfax Inova)</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Sentara Cardiovascular Research Institute</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </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>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>St. Paul's Hospital, Providence Health Care</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 1Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>May 1, 2023</last_update_submitted>
  <last_update_submitted_qc>May 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SAPIEN 3</keyword>
  <keyword>PARTNER 3</keyword>
  <keyword>cardiovascular disease</keyword>
  <keyword>heart disease</keyword>
  <keyword>aortic stenosis</keyword>
  <keyword>SAVR</keyword>
  <keyword>TAVR</keyword>
  <keyword>failing surgical valve</keyword>
  <keyword>failing bioprosthetic valve</keyword>
  <keyword>failing valve</keyword>
  <keyword>SAPIEN 3 Ultra</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03003299
org study id: 2015-08 AVIV
nct id: NCT03003299
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra
      transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
This is a prospective, single-arm, multicenter study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke
time frame: 1 year
description: Number of patients that died and/or had a stroke
measure: Mean gradient
time frame: 30 days
description: Measures the mean aortic pressure gradient from the measured velocity. Units used are mmHg.
measure: Peak gradient
time frame: 30 days
description: Measures the peak aortic pressure gradient from the measured velocity. Units used are mmHg.
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
time frame: 30 days
description: Change from baseline in KCCQ. The KCCQ is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life.
measure: New York Heart Association (NYHA) Classification
time frame: 30 days
description: Change from baseline in NYHA. NYHA is a 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 (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.
measure: Six-Minute Walk Test (6MWT)
time frame: 30 days
description: Change from baseline in 6MWT. The 6-Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
arm group label: TAVR - Failing surgical or transcatheter valve
arm group type: Experimental
description: Patients with a failing surgical or transcatheter bioprosthetic valve will undergo transcatheter aortic valve replacement (TAVR).
intervention type: Device
intervention name: Edwards SAPIEN 3/SAPIEN 3 Ultra THV
description: Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.
arm group label: TAVR - Failing surgical or transcatheter valve
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Chris S Malaisrie, MD
role: Principal Investigator
affiliation: Northwestern University Feinberg School of Medicine
last name: Alan Zajarias, MD
role: Principal Investigator
affiliation: Washington University School of Medicine
last name: Mayra Guerrero, MD
role: Principal Investigator
affiliation: Mayo Clinic
last name: Edwards THV Clinical Affairs
phone: (949) 250-2500
email: THV_CT.gov@Edwards.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
mesh term: Constriction, Pathologic
sharing ipd: No