<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/NCT03042104</url>
  </required_header>
  <id_info>
    <org_study_id>2016-07</org_study_id>
    <nct_id>NCT03042104</nct_id>
  </id_info>
  <brief_title>EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis</brief_title>
  <acronym>EARLY TAVR</acronym>
  <official_title>Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis</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 evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra&#xD;
      Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic&#xD;
      patients with severe, calcific aortic stenosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, controlled, multicenter study. Patients will be randomized&#xD;
      to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 /&#xD;
      SAPIEN 3 Ultra THV or clinical surveillance. Patients will be stratified by whether they are&#xD;
      able to perform a treadmill stress test. Patients who have a positive stress test will be&#xD;
      followed in a registry to collect data on subsequent treatment and mortality, as applicable.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 12, 2017</start_date>
  <completion_date type="Anticipated">March 2032</completion_date>
  <primary_completion_date type="Anticipated">March 2024</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>All-cause death, all stroke, and unplanned cardiovascular hospitalization</measure>
    <time_frame>When all patients have reached 2-year follow-up</time_frame>
    <description>The number of patients that have any of these conditions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Composite of 1) alive, 2) Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥75 and 3) KCCQ decrease ≤10 points</measure>
    <time_frame>2 years</time_frame>
    <description>The number of patients that meet all of these criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular Health</measure>
    <time_frame>2 years</time_frame>
    <description>Echocardiographic measurements that will assess the health of the left ventricle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Left Ventricular Ejection Fraction (LVEF)</measure>
    <time_frame>2 years</time_frame>
    <description>The average change in LVEF from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New onset atrial fibrillation</measure>
    <time_frame>When all patients have reached 2-year follow-up</time_frame>
    <description>The number of patients that develop this condition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death or disabling stroke</measure>
    <time_frame>When all patients have reached 2-year follow-up</time_frame>
    <description>The number of patients that have any of these conditions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">901</enrollment>
  <condition>Heart Diseases</condition>
  <condition>Aortic Stenosis, Severe</condition>
  <arm_group>
    <arm_group_label>TAVR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcatheter aortic valve replacement (TAVR)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CS</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Clinical surveillance (CS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Edwards SAPIEN 3 / SAPIEN 3 Ultra THV</intervention_name>
    <description>Patients will receive the SAPIEN 3 / SAPIEN 3 Ultra THV.</description>
    <arm_group_label>TAVR</arm_group_label>
    <other_name>SAPIEN 3, SAPIEN 3 Ultra</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 65 years of age or older&#xD;
&#xD;
          2. Severe aortic stenosis&#xD;
&#xD;
          3. Patient is asymptomatic&#xD;
&#xD;
          4. LV ejection fraction ≥ 50%&#xD;
&#xD;
          5. Society of Thoracic Surgeons (STS) risk score ≤ 10&#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. Patient is symptomatic&#xD;
&#xD;
          2. Patient has any concomitant valvular, aortic, coronary artery disease requiring&#xD;
             surgery making AVR a Class I indication.&#xD;
&#xD;
          3. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm THV&#xD;
&#xD;
          4. Iliofemoral vessel characteristics that would preclude safe placement of the&#xD;
             introducer sheath.&#xD;
&#xD;
          5. Left ventricular outflow tract calcification that would increase the risk of annular&#xD;
             rupture or significant paravalvular leak post TAVR&#xD;
&#xD;
          6. Evidence of an acute myocardial infarction ≤ 30 days before randomization&#xD;
&#xD;
          7. Aortic valve is unicuspid, bicuspid with unfavorable features for TAVR, or is&#xD;
             non-calcified&#xD;
&#xD;
          8. Severe aortic regurgitation (&gt;3+)&#xD;
&#xD;
          9. Severe mitral regurgitation (&gt;3+) or ≥ moderate mitral stenosis&#xD;
&#xD;
         10. Pre-existing mechanical or bioprosthetic valve in any position&#xD;
&#xD;
         11. Symptomatic carotid or vertebral artery disease or successful treatment of carotid&#xD;
             stenosis within 30 days of randomization&#xD;
&#xD;
         12. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy,&#xD;
             or hypercoagulable states&#xD;
&#xD;
         13. Hemodynamic or respiratory instability requiring inotropic support, mechanical&#xD;
             ventilation or mechanical heart assistance within 30 days of randomization&#xD;
&#xD;
         14. Hypertrophic cardiomyopathy with obstruction&#xD;
&#xD;
         15. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation&#xD;
&#xD;
         16. Inability to tolerate or condition precluding treatment with anti-thrombotic therapy&#xD;
&#xD;
         17. Stroke or transient ischemic attack within 90 days of randomization&#xD;
&#xD;
         18. Renal insufficiency and/or renal replacement therapy&#xD;
&#xD;
         19. Active bacterial endocarditis within 180 days of randomization&#xD;
&#xD;
         20. Severe lung disease or currently on home oxygen&#xD;
&#xD;
         21. Severe pulmonary hypertension&#xD;
&#xD;
         22. History of cirrhosis or any active liver disease&#xD;
&#xD;
         23. Significant frailty as determined by the Heart Team&#xD;
&#xD;
         24. Significant abdominal or thoracic aortic disease that would preclude safe passage of&#xD;
             the delivery system&#xD;
&#xD;
         25. Patient refuses blood products&#xD;
&#xD;
         26. BMI &gt;50 kg/m2&#xD;
&#xD;
         27. Estimated life expectancy &lt;24 months&#xD;
&#xD;
         28. Absolute contraindications or allergy to iodinated contrast that cannot be adequately&#xD;
             treated with pre-medication&#xD;
&#xD;
         29. Currently participating in an investigational drug or another device study.&#xD;
&#xD;
         30. Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with&#xD;
             COVID-19 with sequelae that could confound endpoint assessments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philippe Généreux, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gagnon Cardiovascular Institute - Morristown Medical Center, Cardiovascular Research Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner University Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mills Peninsula Health Services</name>
      <address>
        <city>Burlingame</city>
        <state>California</state>
        <zip>94010</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>Hoag Memorial Hospital Presbyterian</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntington Hospital</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser San Francisco Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Hospital and Clinics Palo Alto</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Hospital Center DC</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cardiac &amp; Vascular Institute Research Foundation</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Heart Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</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 Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore University HealthSystem Research Institution</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alexian Brothers Hospital Network</name>
      <address>
        <city>Lisle</city>
        <state>Illinois</state>
        <zip>60532</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>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Heart Center</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Research Institute of Kansas</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67226</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>Maine Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Maine</state>
        <zip>04102</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>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>Cape Cod Hospital</name>
      <address>
        <city>Hyannis</city>
        <state>Massachusetts</state>
        <zip>02601</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>Minneapolis Heart Institute</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </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>CentraCare Heart</name>
      <address>
        <city>Saint Cloud</city>
        <state>Minnesota</state>
        <zip>56303</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>St. Patrick Hospital</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mary Hitchcock Memorial Hospital</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlantic Health System Hospital Corp - Morristown Medical Center</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newark Beth Israel Medical Center</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers Robert Wood Johnson Medical School</name>
      <address>
        <city>Piscataway</city>
        <state>New Jersey</state>
        <zip>08854</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albany Medical College</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University at Buffalo - Kaleida Health</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winthrop University Hospital Mineola</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York University Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center/ New York Presbyterian Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cornell University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rochester General Hospital</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook University Medical Center</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </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>
  </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>Mount Carmel Health System</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio Health Research Institute</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Portland</name>
      <address>
        <city>Clackamas</city>
        <state>Oregon</state>
        <zip>97015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pinnacle Health</name>
      <address>
        <city>Harrisburg</city>
        <state>Pennsylvania</state>
        <zip>17101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny - Singer Research Institute</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lankenau Medical Center</name>
      <address>
        <city>Wynnewood</city>
        <state>Pennsylvania</state>
        <zip>19096</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>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</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>Texas Health Physician Group</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>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>
  </location>
  <location>
    <facility>
      <name>Intermountain Medical Center Salt Lake City</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inova Heart and Vascular Institute (Fairfax Inova)</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Carilion Medical Center</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Everett</name>
      <address>
        <city>Everett</city>
        <state>Washington</state>
        <zip>98201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</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>Sacred Heart Medical Center</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAMC Clinical Trials Center</name>
      <address>
        <city>Charleston</city>
        <state>West Virginia</state>
        <zip>25304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Health Sciences</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L 2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Ottawa Heart Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4W7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>January 27, 2023</last_update_submitted>
  <last_update_submitted_qc>January 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aortic valve</keyword>
  <keyword>Asymptomatic</keyword>
  <keyword>Transcatheter aortic valve replacement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>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/NCT03042104
org study id: 2016-07
nct id: NCT03042104
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra
      Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic
      patients with severe, calcific aortic stenosis.
This is a prospective, randomized, controlled, multicenter study. Patients will be randomized
      to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 /
      SAPIEN 3 Ultra THV or clinical surveillance. Patients will be stratified by whether they are
      able to perform a treadmill stress test. Patients who have a positive stress test will be
      followed in a registry to collect data on subsequent treatment and mortality, as applicable.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: All-cause death, all stroke, and unplanned cardiovascular hospitalization
time frame: When all patients have reached 2-year follow-up
description: The number of patients that have any of these conditions
measure: Composite of 1) alive, 2) Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥75 and 3) KCCQ decrease ≤10 points
time frame: 2 years
description: The number of patients that meet all of these criteria
measure: Left Ventricular Health
time frame: 2 years
description: Echocardiographic measurements that will assess the health of the left ventricle
measure: Change in Left Ventricular Ejection Fraction (LVEF)
time frame: 2 years
description: The average change in LVEF from baseline
measure: New onset atrial fibrillation
time frame: When all patients have reached 2-year follow-up
description: The number of patients that develop this condition
measure: Death or disabling stroke
time frame: When all patients have reached 2-year follow-up
description: The number of patients that have any of these conditions
arm group label: TAVR
arm group type: Experimental
description: Transcatheter aortic valve replacement (TAVR)
arm group label: CS
arm group type: No Intervention
description: Clinical surveillance (CS)
intervention type: Device
intervention name: Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
description: Patients will receive the SAPIEN 3 / SAPIEN 3 Ultra THV.
arm group label: TAVR
other name: SAPIEN 3, SAPIEN 3 Ultra
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Philippe Généreux, MD
role: Principal Investigator
affiliation: Gagnon Cardiovascular Institute - Morristown Medical Center, Cardiovascular Research Foundation
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Aortic Valve Stenosis
mesh term: Constriction, Pathologic
sharing ipd: No