<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/NCT01700439</url>
  </required_header>
  <id_info>
    <org_study_id>2011-02</org_study_id>
    <nct_id>NCT01700439</nct_id>
  </id_info>
  <brief_title>Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve</brief_title>
  <acronym>TRANSFORM™</acronym>
  <official_title>Multi-CenTer Experience With the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent</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>
      The purpose of the clinical study is to prove that the heart valve device is safe, effective,&#xD;
      and performs as intended.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be&#xD;
      enrolled at up to 35 centers in the US. After replacement of their aortic heart valve with&#xD;
      the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the&#xD;
      following intervals: discharge, 3 months, 1 year, and annually thereafter for a minimum of&#xD;
      five years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2012</start_date>
  <completion_date type="Actual">May 26, 2021</completion_date>
  <primary_completion_date type="Actual">May 26, 2021</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>Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort</measure>
    <time_frame>Events occurring ≥ 31 days and up through 8 years post-implant</time_frame>
    <description>Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success</measure>
    <time_frame>Day of procedure</time_frame>
    <description>Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with maximum of two attempts and subject leaving the operating room (OR) with valve in place.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success</measure>
    <time_frame>Day of procedure through discharge or 10 days post index procedure, whichever comes first.</time_frame>
    <description>Procedural success is defined as device technical success followed by the absence of adverse events resulting in device reoperation implant of permanent pacemaker (with baseline sinus rhythm and no other pre-existing conduction issues), or valve-related death within discharge or 10 days post index procedure, whichever comes first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Amount of Time Subject Spent on Cardiopulmonary Bypass</measure>
    <time_frame>Day of procedure</time_frame>
    <description>Surgical and hospitalization factors - Cardiopulmonary bypass time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Subject Time on Cardiopulmonary Cross Clamp</measure>
    <time_frame>Day of procedure</time_frame>
    <description>Surgical and hospitalization factors - Cardiopulmonary cross clamp time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Number of Days Subjects Were in the Intensive Care Unit (ICU)</measure>
    <time_frame>Day of procedure through discharge from the hospital</time_frame>
    <description>Length of time surgical subjects were in the intensive care unit (ICU) after their heart valve replacement procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject's New York Heart Association (NYHA) Classification Over Time</measure>
    <time_frame>Baseline, 3-months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8 Years</time_frame>
    <description>The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity.&#xD;
Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.&#xD;
Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.&#xD;
Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.&#xD;
Symptoms of heart failure or the anginal syndrome may be present even at rest.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject's Average Mean Gradient Measurements Over Time</measure>
    <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up</time_frame>
    <description>Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject's Average Peak Gradient Measurements Over Time</measure>
    <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up</time_frame>
    <description>Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject's Effective Orifice Area (EOA) Measurement Over Time</measure>
    <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
    <description>Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject's Effective Orifice Area Index (EOAI) Measurement Over Time</measure>
    <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
    <description>Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject's Performance Index Measurement Over Time</measure>
    <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
    <description>Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Performance Index is evaluated by echocardiography over time and are dependent on the size and type of the valve. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject's Cardiac Output Measurement at Over Time</measure>
    <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
    <description>Cardiac output is the amount of blood the heart pumps through the circulatory system in a minute. Cardiac output is evaluated by echocardiography over time. Normal cardiac output in healthy volunteers over 60 years of age was reported between 3.1 and 6.4 liters per minute. In general, a higher value is considered better, and a lower value is considered worse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject's Cardiac Index Measurement Over Time</measure>
    <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
    <description>Hemodynamic performance - Cardiac index (CI) evaluated by echocardiography. Cardiac index is an assessment of the cardiac output value based on the patient's size. To obtain the cardiac index, divide the cardiac output by the person's body surface area (BSA). Cardiac Index is a useful marker of how well the heart is functioning as a pump by directly correlating the volume of blood pumped by the heart with an individual's body surface area. Normal cardiac output index in healthy volunteers over 60 years of age was reported between 1.1 and 3.2 L/min/m^2. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size</measure>
    <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
    <description>Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. Higher numbers on the scale show a worsening outcome.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey</measure>
    <time_frame>Baseline and one year follow-up</time_frame>
    <description>The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states. The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worst health status.</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject's Average White Blood Cell Count Over Time</measure>
    <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
    <description>Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection. The normal reference range for WBC count is 4.5 to 10 10^3 cells/microliters. In general, results either lower or higher than the normal range can indicate something is wrong.</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject's Average Red Blood Cell Count Over Time</measure>
    <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
    <description>The red blood cell (RBC) count is a test that measures the number of oxygen-carrying blood cells in your blood. The red blood cell count normal range for women is 4.2 to 5.4 10^6 cells/microliters and for men is 4.7 to 6.1 10^6 cells/microliters. A high red blood cell count may indicate that you have a condition that's preventing you from getting enough oxygen. A low RBC may be caused by an infection, or a medical condition related to anemia. In general, results either lower or higher than the normal range can indicate something is wrong.</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject's Average Hematocrit Percentage Over Time</measure>
    <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
    <description>Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. A hematocrit test measures the proportion of red blood cells in your blood. Red blood cells carry oxygen throughout your body. Having too few or too many red blood cells can be a sign of certain diseases. Normal hematocrit ranges for adult females are 36% to 44% and for adult males are 41% to 50%. In general, results either lower or higher than the normal range can indicate something is wrong.</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject's Average Hemoglobin Percentage Over Time</measure>
    <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
    <description>Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. In males, a healthy hemoglobin level is between 13.2 and 16.6 g/dL. In females, a hemoglobin count of between 11.6 and 15 g/dL is considered normal and healthy. In general, results either lower or higher than the normal range can indicate something is wrong.</description>
  </other_outcome>
  <other_outcome>
    <measure>Subject's Average Plasma Free Hemoglobin Over Time</measure>
    <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
    <description>Laboratory Analysis of Plasma Free Hemoglobin (Hgb) of blood drawn from subject. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood). The reference range for plasma free hemoglobin is 0.0 to 15.2 mg/dL. In general, values higher than this can indicate something is wrong.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">934</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <condition>Aortic Valve Stenosis With Insufficiency</condition>
  <condition>Regurgitation, Aortic Valve</condition>
  <condition>Aortic Valve Incompetence</condition>
  <arm_group>
    <arm_group_label>EDWARDS INTUITY valve</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects enrolled into the study are implanted with the EDWARDS INTUITY Valve System.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EDWARDS INTUITY valve</intervention_name>
    <description>Surgical replacement of the aortic valve with the EDWARDS INTUITY valve.</description>
    <arm_group_label>EDWARDS INTUITY valve</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion Criteria - Subjects will be required to meet all inclusion criteria:&#xD;
&#xD;
               1. Male or female, age 18 years or older&#xD;
&#xD;
               2. Has aortic stenosis or stenosis-insufficiency of an aortic valve requiring a&#xD;
                  planned replacement as indicated in the preoperative evaluation&#xD;
&#xD;
               3. Is scheduled to undergo planned aortic valve replacement with or without&#xD;
                  concomitant coronary bypass surgery&#xD;
&#xD;
               4. Provide written informed consent&#xD;
&#xD;
               5. Geographically stable and agrees to attend follow-up assessments until all&#xD;
                  subjects have completed 5 years of follow up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Exclusion Criteria - Subjects will not be eligible for trial participation if any of the&#xD;
        following criteria are present:&#xD;
&#xD;
          1. Pure aortic insufficiency&#xD;
&#xD;
          2. Requires emergency surgery&#xD;
&#xD;
          3. Previous aortic valve replacement&#xD;
&#xD;
          4. Had prior mitral, tricuspid or pulmonic valve surgery, which included implant of a&#xD;
             bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ&#xD;
&#xD;
          5. Requires multiple valve replacement/repair&#xD;
&#xD;
          6. Requires a surgical procedure outside of the cardiac area (e.g., vascular&#xD;
             endarterectomy, vascular bypass, tumor removal)&#xD;
&#xD;
          7. Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention&#xD;
&#xD;
          8. Active endocarditis/myocarditis or endocarditis/ myocarditis within 3 months prior to&#xD;
             the scheduled AVR surgery&#xD;
&#xD;
          9. Myocardial infarction (MI) within thirty (30) days prior to valve replacement surgery&#xD;
&#xD;
         10. Renal insufficiency as determined by creatinine ≥ 2.5 mg/dL at screening or end-stage&#xD;
             renal disease requiring chronic dialysis&#xD;
&#xD;
         11. Hyperparathyroidism&#xD;
&#xD;
         12. MRI or CT-scan confirmed cerebrovascular accident (CVA), or transient ischemic attack&#xD;
             (TIA) within 6 months (180 days) of the procedure&#xD;
&#xD;
         13. Presence of non-cardiac disease limiting life expectancy to less than 12 months&#xD;
&#xD;
         14. Hypertrophic obstructive cardiomyopathy (HOCM)&#xD;
&#xD;
         15. Left ventricular ejection fraction ≤ 25%&#xD;
&#xD;
         16. Documented history of substance (drug or alcohol) abuse within the last 5 years&#xD;
&#xD;
         17. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation&#xD;
&#xD;
         18. Hemodynamic or respiratory instability requiring inotropic support, mechanical&#xD;
             circulatory support, or mechanical ventilation within 30 days prior to the procedure&#xD;
&#xD;
         19. Pregnancy, lactation, or planning to become pregnant;&#xD;
&#xD;
         20. Currently incarcerated or unable to give voluntary informed consent&#xD;
&#xD;
         21. Leucopenia (WBC &lt; 3.5x 103/µL), or acute anemia (Hgb &lt; 10.0 gm/dL or 6 mmol/L), or&#xD;
             thrombocytopenia (platelet count &lt; 50x 103/µL), or history of bleeding diathesis or&#xD;
             coagulopathy&#xD;
&#xD;
         22. History of myxomatous disease/connective tissue disorders (e.g., Marfan's Syndrome)&#xD;
&#xD;
         23. Current or recent participation (within 6 weeks prior to surgery) in an&#xD;
             investigational drug or device trial&#xD;
&#xD;
               -  Intra-operative Exclusion Criteria&#xD;
&#xD;
         24. Anatomic variances which contraindicate implant of the trial valve, such as:&#xD;
&#xD;
               1. anomalous coronary arteries&#xD;
&#xD;
               2. annular deformation or extensive calcification of the annulus or aortic root&#xD;
                  which cannot be removed&#xD;
&#xD;
               3. significant calcium on the anterior mitral leaflet&#xD;
&#xD;
               4. pronounced septal calcification&#xD;
&#xD;
               5. position of coronary ostia relative to Model 8300ACD valve that would result in&#xD;
                  obstruction of blood flow&#xD;
&#xD;
         25. Available devices are not suitably sized for the subject's annulus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Glenn Barnhart, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Swedish Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Walter Randolph Chitwood, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>East Carolina University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Keck Hospital of University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </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>Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy General Hospital</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Hospital</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</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>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Michigan Medical School</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</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>Cooper University Hospital</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore Long Island Jewish Health System</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York University 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</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mission Hospital</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>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>Good Samaritan Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45220</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>Pinnacle Health at Harrisburg Hospital</name>
      <address>
        <city>Harrisburg</city>
        <state>Pennsylvania</state>
        <zip>17010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</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>St. Thomas Health</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37205</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>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Heart Hospital Baylor Plano</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</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>Aurora St Luke's Medical Center</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://manual.jointcommission.org/releases/TJC2016A/DataElem0439.html</url>
    <description>New York Heart Association Classification</description>
  </link>
  <results_reference>
    <citation>Barnhart GR, Accola KD, Grossi EA, Woo YJ, Mumtaz MA, Sabik JF, Slachman FN, Patel HJ, Borger MA, Garrett HE Jr, Rodriguez E, McCarthy PM, Ryan WH, Duhay FG, Mack MJ, Chitwood WR Jr; TRANSFORM Trial Investigators. TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve. J Thorac Cardiovasc Surg. 2017 Feb;153(2):241-251.e2. doi: 10.1016/j.jtcvs.2016.09.062. Epub 2016 Oct 15.</citation>
    <PMID>27817951</PMID>
  </results_reference>
  <results_reference>
    <citation>Romano MA, Koeckert M, Mumtaz MA, Slachman FN, Patel HJ, Chitwood WR Jr, Barnhart GR, Grossi EA; TRANSFORM Trial Investigators. Permanent Pacemaker Implantation After Rapid Deployment Aortic Valve Replacement. Ann Thorac Surg. 2018 Sep;106(3):685-690. doi: 10.1016/j.athoracsur.2018.03.055. Epub 2018 Apr 26.</citation>
    <PMID>29705366</PMID>
  </results_reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <results_first_submitted>September 22, 2017</results_first_submitted>
  <results_first_submitted_qc>December 12, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">December 13, 2017</results_first_posted>
  <last_update_submitted>May 12, 2023</last_update_submitted>
  <last_update_submitted_qc>May 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aortic valve</keyword>
  <keyword>Heart valve</keyword>
  <keyword>Tissue valve</keyword>
  <keyword>Bioprosthesis</keyword>
  <keyword>Valve disorder</keyword>
  <keyword>Valve disease</keyword>
  <keyword>Cardiac surgery</keyword>
  <keyword>Less invasive cardiac surgery</keyword>
  <keyword>Aortic valve stenosis</keyword>
  <keyword>Aortic valve regurgitation</keyword>
  <keyword>Bovine pericardium</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Aortic Valve Insufficiency</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data will not be available to other researchers.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 3, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT01700439/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Edwards TRANSFORM Trial Cohort</title>
          <description>Subjects who were enrolled in the TRANSFORM trial and were eligible to receive an INTUITY study surgical aortic heart valve.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="934"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Study Valve Group</title>
              <participants_list>
                <participants group_id="P1" count="885">Received the Edwards INTUITY surgical aortic heart valve.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Discharge</title>
              <participants_list>
                <participants group_id="P1" count="925"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>3 Month</title>
              <participants_list>
                <participants group_id="P1" count="862"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>1 Year</title>
              <participants_list>
                <participants group_id="P1" count="842"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>2 Year</title>
              <participants_list>
                <participants group_id="P1" count="795"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>3 Year</title>
              <participants_list>
                <participants group_id="P1" count="720"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>4 Year</title>
              <participants_list>
                <participants group_id="P1" count="667"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>5 Year</title>
              <participants_list>
                <participants group_id="P1" count="577"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>6 Year</title>
              <participants_list>
                <participants group_id="P1" count="357"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>7 Year</title>
              <participants_list>
                <participants group_id="P1" count="164"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>8 Year</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="518"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="416"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="183"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="186"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Edwards TRANSFORM Trial Cohort</title>
          <description>Subjects who were enrolled in the TRANSFORM trial and were eligible to receive an Edwards INTUITY surgical aortic heart valve.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="934"/>
          </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="73.4" spread="8.3"/>
                  </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="336"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="598"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="865"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="934"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort</title>
        <description>Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]</description>
        <time_frame>Events occurring ≥ 31 days and up through 8 years post-implant</time_frame>
        <population>The group of subjects that received the Edwards INTUITY surgical aortic heart valve.</population>
        <group_list>
          <group group_id="O1">
            <title>Edwards INTUITY Surgical Aortic Heart Valve</title>
            <description>Subjects who received an Edwards INTUITY surgical aortic heart valve.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort</title>
          <description>Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]</description>
          <population>The group of subjects that received the Edwards INTUITY surgical aortic heart valve.</population>
          <units>Percentage of events/late patient years</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="885"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All cause mortality</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Valve related mortality</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study valve reoperation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study valve explant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thromboembolism</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Valve thrombosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Endocarditis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Major bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All paravalvular leak</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Major paravalvular leak (PVL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemolysis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-structural valve dysfunction other than PVL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Valve migration/embolization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Valve malposition</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Valve instability</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Valve dislodgement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Valve stenosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Structural valve deterioration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Conduction defects</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Conduction defects with permanent pacemaker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Conduction defects without permanent pacemaker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success</title>
        <description>Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with maximum of two attempts and subject leaving the operating room (OR) with valve in place.</description>
        <time_frame>Day of procedure</time_frame>
        <population>Patients who were eligible to receive an Edwards INTUITY surgical aortic heart valve.</population>
        <group_list>
          <group group_id="O1">
            <title>Edwards TRANSFORM Trial Cohort</title>
            <description>Subjects who were enrolled in the TRANSFORM trial and were eligible to receive an Edwards INTUITY surgical aortic heart valve.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success</title>
          <description>Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with maximum of two attempts and subject leaving the operating room (OR) with valve in place.</description>
          <population>Patients who were eligible to receive an Edwards INTUITY surgical aortic heart valve.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="934"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success</title>
        <description>Procedural success is defined as device technical success followed by the absence of adverse events resulting in device reoperation implant of permanent pacemaker (with baseline sinus rhythm and no other pre-existing conduction issues), or valve-related death within discharge or 10 days post index procedure, whichever comes first.</description>
        <time_frame>Day of procedure through discharge or 10 days post index procedure, whichever comes first.</time_frame>
        <population>Patients who were eligible to receive an Edwards INTUITY surgical aortic heart valve.</population>
        <group_list>
          <group group_id="O1">
            <title>Edwards TRANSFORM Trial Cohort</title>
            <description>Subjects who were enrolled in the TRANSFORM trial and were eligible to receive an Edwards INTUITY surgical aortic heart valve.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success</title>
          <description>Procedural success is defined as device technical success followed by the absence of adverse events resulting in device reoperation implant of permanent pacemaker (with baseline sinus rhythm and no other pre-existing conduction issues), or valve-related death within discharge or 10 days post index procedure, whichever comes first.</description>
          <population>Patients who were eligible to receive an Edwards INTUITY surgical aortic heart valve.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="934"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Amount of Time Subject Spent on Cardiopulmonary Bypass</title>
        <description>Surgical and hospitalization factors - Cardiopulmonary bypass time</description>
        <time_frame>Day of procedure</time_frame>
        <population>The group of subjects that received the Edwards INTUITY surgical aortic heart valve.</population>
        <group_list>
          <group group_id="O1">
            <title>Edwards INTUITY Surgical Aortic Heart Valve</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Amount of Time Subject Spent on Cardiopulmonary Bypass</title>
          <description>Surgical and hospitalization factors - Cardiopulmonary bypass time</description>
          <population>The group of subjects that received the Edwards INTUITY surgical aortic heart valve.</population>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="885"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.6" spread="37.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Subject Time on Cardiopulmonary Cross Clamp</title>
        <description>Surgical and hospitalization factors - Cardiopulmonary cross clamp time</description>
        <time_frame>Day of procedure</time_frame>
        <population>The group of subjects that received the Edwards INTUITY surgical aortic heart valve. Data is not available for one subject.</population>
        <group_list>
          <group group_id="O1">
            <title>Edwards INTUITY Surgical Aortic Heart Valve</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Subject Time on Cardiopulmonary Cross Clamp</title>
          <description>Surgical and hospitalization factors - Cardiopulmonary cross clamp time</description>
          <population>The group of subjects that received the Edwards INTUITY surgical aortic heart valve. Data is not available for one subject.</population>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="884"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.4" spread="29.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Number of Days Subjects Were in the Intensive Care Unit (ICU)</title>
        <description>Length of time surgical subjects were in the intensive care unit (ICU) after their heart valve replacement procedure.</description>
        <time_frame>Day of procedure through discharge from the hospital</time_frame>
        <population>The group of subjects that received the Edwards INTUITY surgical aortic heart valve. Data is not available for 4 subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Edwards INTUITY Surgical Aortic Heart Valve</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Number of Days Subjects Were in the Intensive Care Unit (ICU)</title>
          <description>Length of time surgical subjects were in the intensive care unit (ICU) after their heart valve replacement procedure.</description>
          <population>The group of subjects that received the Edwards INTUITY surgical aortic heart valve. Data is not available for 4 subjects.</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="881"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject's New York Heart Association (NYHA) Classification Over Time</title>
        <description>The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity.&#xD;
Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.&#xD;
Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.&#xD;
Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.&#xD;
Symptoms of heart failure or the anginal syndrome may be present even at rest.</description>
        <time_frame>Baseline, 3-months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8 Years</time_frame>
        <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - Class I</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O2">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - Class II</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O3">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - Class III</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O4">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - Class IV</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject's New York Heart Association (NYHA) Classification Over Time</title>
          <description>The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity.&#xD;
Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.&#xD;
Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.&#xD;
Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.&#xD;
Symptoms of heart failure or the anginal syndrome may be present even at rest.</description>
          <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="885"/>
                <count group_id="O2" value="885"/>
                <count group_id="O3" value="885"/>
                <count group_id="O4" value="885"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="882"/>
                    <count group_id="O2" value="882"/>
                    <count group_id="O3" value="882"/>
                    <count group_id="O4" value="882"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135"/>
                    <measurement group_id="O2" value="468"/>
                    <measurement group_id="O3" value="264"/>
                    <measurement group_id="O4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="839"/>
                    <count group_id="O2" value="839"/>
                    <count group_id="O3" value="839"/>
                    <count group_id="O4" value="839"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="671"/>
                    <measurement group_id="O2" value="148"/>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="814"/>
                    <count group_id="O2" value="814"/>
                    <count group_id="O3" value="814"/>
                    <count group_id="O4" value="814"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="648"/>
                    <measurement group_id="O2" value="145"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="764"/>
                    <count group_id="O2" value="764"/>
                    <count group_id="O3" value="764"/>
                    <count group_id="O4" value="764"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="606"/>
                    <measurement group_id="O2" value="133"/>
                    <measurement group_id="O3" value="22"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="693"/>
                    <count group_id="O2" value="693"/>
                    <count group_id="O3" value="693"/>
                    <count group_id="O4" value="693"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="551"/>
                    <measurement group_id="O2" value="122"/>
                    <measurement group_id="O3" value="19"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="634"/>
                    <count group_id="O2" value="634"/>
                    <count group_id="O3" value="634"/>
                    <count group_id="O4" value="634"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="487"/>
                    <measurement group_id="O2" value="123"/>
                    <measurement group_id="O3" value="21"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="543"/>
                    <count group_id="O2" value="543"/>
                    <count group_id="O3" value="543"/>
                    <count group_id="O4" value="543"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="420"/>
                    <measurement group_id="O2" value="109"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="328"/>
                    <count group_id="O2" value="328"/>
                    <count group_id="O3" value="328"/>
                    <count group_id="O4" value="328"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="251"/>
                    <measurement group_id="O2" value="63"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="144"/>
                    <count group_id="O3" value="144"/>
                    <count group_id="O4" value="144"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="34"/>
                    <count group_id="O4" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject's Average Mean Gradient Measurements Over Time</title>
        <description>Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.</description>
        <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up</time_frame>
        <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 19mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O2">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 21mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O3">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 23mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O4">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 25mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O5">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 27mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject's Average Mean Gradient Measurements Over Time</title>
          <description>Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.</description>
          <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="179"/>
                <count group_id="O3" value="291"/>
                <count group_id="O4" value="261"/>
                <count group_id="O5" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="175"/>
                    <count group_id="O3" value="282"/>
                    <count group_id="O4" value="246"/>
                    <count group_id="O5" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.7" spread="6.2"/>
                    <measurement group_id="O2" value="13.0" spread="4.1"/>
                    <measurement group_id="O3" value="12.3" spread="4.0"/>
                    <measurement group_id="O4" value="11.2" spread="3.7"/>
                    <measurement group_id="O5" value="9.7" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="166"/>
                    <count group_id="O3" value="268"/>
                    <count group_id="O4" value="241"/>
                    <count group_id="O5" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.4" spread="4.4"/>
                    <measurement group_id="O2" value="11.1" spread="3.3"/>
                    <measurement group_id="O3" value="10.3" spread="3.5"/>
                    <measurement group_id="O4" value="9.7" spread="3.2"/>
                    <measurement group_id="O5" value="8.3" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="163"/>
                    <count group_id="O3" value="265"/>
                    <count group_id="O4" value="220"/>
                    <count group_id="O5" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.9" spread="4.0"/>
                    <measurement group_id="O2" value="11.3" spread="3.6"/>
                    <measurement group_id="O3" value="10.0" spread="3.2"/>
                    <measurement group_id="O4" value="9.3" spread="3.0"/>
                    <measurement group_id="O5" value="8.1" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="144"/>
                    <count group_id="O3" value="249"/>
                    <count group_id="O4" value="211"/>
                    <count group_id="O5" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.1" spread="4.5"/>
                    <measurement group_id="O2" value="11.1" spread="3.6"/>
                    <measurement group_id="O3" value="10.0" spread="3.7"/>
                    <measurement group_id="O4" value="9.3" spread="2.9"/>
                    <measurement group_id="O5" value="8.1" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="126"/>
                    <count group_id="O3" value="229"/>
                    <count group_id="O4" value="192"/>
                    <count group_id="O5" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.7" spread="4.6"/>
                    <measurement group_id="O2" value="11.0" spread="4.3"/>
                    <measurement group_id="O3" value="10.0" spread="3.4"/>
                    <measurement group_id="O4" value="9.5" spread="3.5"/>
                    <measurement group_id="O5" value="7.9" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="113"/>
                    <count group_id="O3" value="201"/>
                    <count group_id="O4" value="175"/>
                    <count group_id="O5" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8" spread="3.8"/>
                    <measurement group_id="O2" value="10.8" spread="3.7"/>
                    <measurement group_id="O3" value="10.3" spread="6.7"/>
                    <measurement group_id="O4" value="9.5" spread="4.0"/>
                    <measurement group_id="O5" value="8.0" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="153"/>
                    <count group_id="O4" value="142"/>
                    <count group_id="O5" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.4" spread="3.5"/>
                    <measurement group_id="O2" value="10.7" spread="3.9"/>
                    <measurement group_id="O3" value="10.0" spread="5.6"/>
                    <measurement group_id="O4" value="9.8" spread="6.5"/>
                    <measurement group_id="O5" value="7.9" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="94"/>
                    <count group_id="O4" value="80"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.1" spread="3.9"/>
                    <measurement group_id="O2" value="10.5" spread="3.6"/>
                    <measurement group_id="O3" value="11.1" spread="6.4"/>
                    <measurement group_id="O4" value="9.3" spread="4.0"/>
                    <measurement group_id="O5" value="9.2" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="33"/>
                    <count group_id="O4" value="29"/>
                    <count group_id="O5" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1" spread="4.0"/>
                    <measurement group_id="O2" value="10.8" spread="3.1"/>
                    <measurement group_id="O3" value="12.8" spread="7.4"/>
                    <measurement group_id="O4" value="9.8" spread="4.0"/>
                    <measurement group_id="O5" value="7.7" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.2" spread="0.0"/>
                    <measurement group_id="O2" value="13.2" spread="5.0"/>
                    <measurement group_id="O3" value="12.3" spread="8.3"/>
                    <measurement group_id="O4" value="12.9" spread="8.2"/>
                    <measurement group_id="O5" value="9.4" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject's Average Peak Gradient Measurements Over Time</title>
        <description>Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.</description>
        <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up</time_frame>
        <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 19mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O2">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 21mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O3">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 23mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O4">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 25mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O5">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 27mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject's Average Peak Gradient Measurements Over Time</title>
          <description>Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.</description>
          <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="179"/>
                <count group_id="O3" value="291"/>
                <count group_id="O4" value="261"/>
                <count group_id="O5" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="175"/>
                    <count group_id="O3" value="282"/>
                    <count group_id="O4" value="246"/>
                    <count group_id="O5" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.8" spread="11.9"/>
                    <measurement group_id="O2" value="24.1" spread="7.9"/>
                    <measurement group_id="O3" value="22.9" spread="7.8"/>
                    <measurement group_id="O4" value="20.8" spread="6.8"/>
                    <measurement group_id="O5" value="17.9" spread="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="166"/>
                    <count group_id="O3" value="268"/>
                    <count group_id="O4" value="241"/>
                    <count group_id="O5" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.0" spread="8.0"/>
                    <measurement group_id="O2" value="19.9" spread="6.4"/>
                    <measurement group_id="O3" value="19.0" spread="6.5"/>
                    <measurement group_id="O4" value="17.6" spread="5.8"/>
                    <measurement group_id="O5" value="15.0" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="163"/>
                    <count group_id="O3" value="265"/>
                    <count group_id="O4" value="220"/>
                    <count group_id="O5" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0" spread="7.7"/>
                    <measurement group_id="O2" value="20.5" spread="6.5"/>
                    <measurement group_id="O3" value="18.2" spread="6.0"/>
                    <measurement group_id="O4" value="17.0" spread="5.7"/>
                    <measurement group_id="O5" value="14.6" spread="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="144"/>
                    <count group_id="O3" value="249"/>
                    <count group_id="O4" value="211"/>
                    <count group_id="O5" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.4" spread="7.9"/>
                    <measurement group_id="O2" value="20.2" spread="6.6"/>
                    <measurement group_id="O3" value="18.4" spread="6.8"/>
                    <measurement group_id="O4" value="17.0" spread="5.3"/>
                    <measurement group_id="O5" value="14.6" spread="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="126"/>
                    <count group_id="O3" value="229"/>
                    <count group_id="O4" value="192"/>
                    <count group_id="O5" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.7" spread="8.2"/>
                    <measurement group_id="O2" value="20.0" spread="7.8"/>
                    <measurement group_id="O3" value="18.5" spread="6.3"/>
                    <measurement group_id="O4" value="17.4" spread="6.3"/>
                    <measurement group_id="O5" value="14.5" spread="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="113"/>
                    <count group_id="O3" value="201"/>
                    <count group_id="O4" value="175"/>
                    <count group_id="O5" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.0" spread="6.6"/>
                    <measurement group_id="O2" value="19.8" spread="6.8"/>
                    <measurement group_id="O3" value="18.9" spread="10.4"/>
                    <measurement group_id="O4" value="17.6" spread="7.2"/>
                    <measurement group_id="O5" value="14.6" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="153"/>
                    <count group_id="O4" value="142"/>
                    <count group_id="O5" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.7" spread="6.3"/>
                    <measurement group_id="O2" value="19.5" spread="7.0"/>
                    <measurement group_id="O3" value="18.4" spread="10.0"/>
                    <measurement group_id="O4" value="17.9" spread="10.7"/>
                    <measurement group_id="O5" value="14.5" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="94"/>
                    <count group_id="O4" value="80"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.6" spread="6.1"/>
                    <measurement group_id="O2" value="19.1" spread="6.7"/>
                    <measurement group_id="O3" value="19.8" spread="9.4"/>
                    <measurement group_id="O4" value="17.1" spread="7.3"/>
                    <measurement group_id="O5" value="16.9" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="33"/>
                    <count group_id="O4" value="29"/>
                    <count group_id="O5" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.1" spread="7.1"/>
                    <measurement group_id="O2" value="19.6" spread="5.9"/>
                    <measurement group_id="O3" value="23.5" spread="13.3"/>
                    <measurement group_id="O4" value="18.5" spread="7.7"/>
                    <measurement group_id="O5" value="14.6" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.3" spread="0.0"/>
                    <measurement group_id="O2" value="24.4" spread="8.1"/>
                    <measurement group_id="O3" value="21.0" spread="12.6"/>
                    <measurement group_id="O4" value="22.7" spread="14.7"/>
                    <measurement group_id="O5" value="17.2" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject's Effective Orifice Area (EOA) Measurement Over Time</title>
        <description>Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve.</description>
        <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
        <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 19mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O2">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 21mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O3">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 23mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O4">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 25mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O5">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 27mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject's Effective Orifice Area (EOA) Measurement Over Time</title>
          <description>Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve.</description>
          <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
          <units>Centimeters squared</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="179"/>
                <count group_id="O3" value="291"/>
                <count group_id="O4" value="261"/>
                <count group_id="O5" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="257"/>
                    <count group_id="O4" value="200"/>
                    <count group_id="O5" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="0.1"/>
                    <measurement group_id="O2" value="1.3" spread="0.2"/>
                    <measurement group_id="O3" value="1.7" spread="0.2"/>
                    <measurement group_id="O4" value="1.9" spread="0.2"/>
                    <measurement group_id="O5" value="2.2" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="258"/>
                    <count group_id="O4" value="228"/>
                    <count group_id="O5" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="0.1"/>
                    <measurement group_id="O2" value="1.3" spread="0.1"/>
                    <measurement group_id="O3" value="1.7" spread="0.2"/>
                    <measurement group_id="O4" value="1.9" spread="0.2"/>
                    <measurement group_id="O5" value="2.2" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="256"/>
                    <count group_id="O4" value="214"/>
                    <count group_id="O5" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="0.1"/>
                    <measurement group_id="O2" value="1.4" spread="0.1"/>
                    <measurement group_id="O3" value="1.7" spread="0.2"/>
                    <measurement group_id="O4" value="1.9" spread="0.2"/>
                    <measurement group_id="O5" value="2.2" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="142"/>
                    <count group_id="O3" value="240"/>
                    <count group_id="O4" value="201"/>
                    <count group_id="O5" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="0.1"/>
                    <measurement group_id="O2" value="1.4" spread="0.1"/>
                    <measurement group_id="O3" value="1.7" spread="0.2"/>
                    <measurement group_id="O4" value="1.9" spread="0.2"/>
                    <measurement group_id="O5" value="2.2" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="122"/>
                    <count group_id="O3" value="220"/>
                    <count group_id="O4" value="177"/>
                    <count group_id="O5" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="0.1"/>
                    <measurement group_id="O2" value="1.4" spread="0.1"/>
                    <measurement group_id="O3" value="1.7" spread="0.2"/>
                    <measurement group_id="O4" value="1.9" spread="0.2"/>
                    <measurement group_id="O5" value="2.1" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="111"/>
                    <count group_id="O3" value="193"/>
                    <count group_id="O4" value="167"/>
                    <count group_id="O5" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.1"/>
                    <measurement group_id="O2" value="1.4" spread="0.1"/>
                    <measurement group_id="O3" value="1.7" spread="0.2"/>
                    <measurement group_id="O4" value="1.9" spread="0.2"/>
                    <measurement group_id="O5" value="2.1" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="150"/>
                    <count group_id="O4" value="130"/>
                    <count group_id="O5" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.1"/>
                    <measurement group_id="O2" value="1.4" spread="0.2"/>
                    <measurement group_id="O3" value="1.7" spread="0.2"/>
                    <measurement group_id="O4" value="1.8" spread="0.2"/>
                    <measurement group_id="O5" value="2.1" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="88"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.1"/>
                    <measurement group_id="O2" value="1.4" spread="0.1"/>
                    <measurement group_id="O3" value="1.6" spread="0.2"/>
                    <measurement group_id="O4" value="1.9" spread="0.2"/>
                    <measurement group_id="O5" value="2.0" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="32"/>
                    <count group_id="O4" value="27"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.1"/>
                    <measurement group_id="O2" value="1.4" spread="0.1"/>
                    <measurement group_id="O3" value="1.6" spread="0.3"/>
                    <measurement group_id="O4" value="1.8" spread="0.3"/>
                    <measurement group_id="O5" value="2.1" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="0.0"/>
                    <measurement group_id="O2" value="1.4" spread="0.1"/>
                    <measurement group_id="O3" value="1.6" spread="0.3"/>
                    <measurement group_id="O4" value="1.7" spread="0.3"/>
                    <measurement group_id="O5" value="2.1" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject's Effective Orifice Area Index (EOAI) Measurement Over Time</title>
        <description>Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve.</description>
        <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
        <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 19mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O2">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 21mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O3">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 23mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O4">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 25mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O5">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 27mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject's Effective Orifice Area Index (EOAI) Measurement Over Time</title>
          <description>Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve.</description>
          <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
          <units>centimeters squared/meters squared</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="179"/>
                <count group_id="O3" value="291"/>
                <count group_id="O4" value="261"/>
                <count group_id="O5" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="160"/>
                    <count group_id="O3" value="256"/>
                    <count group_id="O4" value="199"/>
                    <count group_id="O5" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.1"/>
                    <measurement group_id="O2" value="0.7" spread="0.1"/>
                    <measurement group_id="O3" value="0.8" spread="0.1"/>
                    <measurement group_id="O4" value="0.9" spread="0.1"/>
                    <measurement group_id="O5" value="1.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="257"/>
                    <count group_id="O4" value="228"/>
                    <count group_id="O5" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.1"/>
                    <measurement group_id="O2" value="0.7" spread="0.1"/>
                    <measurement group_id="O3" value="0.8" spread="0.1"/>
                    <measurement group_id="O4" value="0.9" spread="0.1"/>
                    <measurement group_id="O5" value="1.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="256"/>
                    <count group_id="O4" value="211"/>
                    <count group_id="O5" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.1"/>
                    <measurement group_id="O2" value="0.7" spread="0.1"/>
                    <measurement group_id="O3" value="0.8" spread="0.1"/>
                    <measurement group_id="O4" value="0.9" spread="0.1"/>
                    <measurement group_id="O5" value="1.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="142"/>
                    <count group_id="O3" value="239"/>
                    <count group_id="O4" value="198"/>
                    <count group_id="O5" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.1"/>
                    <measurement group_id="O2" value="0.7" spread="0.1"/>
                    <measurement group_id="O3" value="0.8" spread="0.1"/>
                    <measurement group_id="O4" value="0.9" spread="0.1"/>
                    <measurement group_id="O5" value="1.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="122"/>
                    <count group_id="O3" value="220"/>
                    <count group_id="O4" value="177"/>
                    <count group_id="O5" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.1"/>
                    <measurement group_id="O2" value="0.7" spread="0.1"/>
                    <measurement group_id="O3" value="0.8" spread="0.1"/>
                    <measurement group_id="O4" value="0.9" spread="0.1"/>
                    <measurement group_id="O5" value="1.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="111"/>
                    <count group_id="O3" value="193"/>
                    <count group_id="O4" value="167"/>
                    <count group_id="O5" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.1"/>
                    <measurement group_id="O2" value="0.8" spread="0.1"/>
                    <measurement group_id="O3" value="0.8" spread="0.1"/>
                    <measurement group_id="O4" value="0.9" spread="0.1"/>
                    <measurement group_id="O5" value="1.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="150"/>
                    <count group_id="O4" value="129"/>
                    <count group_id="O5" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.1"/>
                    <measurement group_id="O2" value="0.7" spread="0.1"/>
                    <measurement group_id="O3" value="0.8" spread="0.1"/>
                    <measurement group_id="O4" value="0.9" spread="0.1"/>
                    <measurement group_id="O5" value="1.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="87"/>
                    <count group_id="O4" value="77"/>
                    <count group_id="O5" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.1"/>
                    <measurement group_id="O2" value="0.7" spread="0.1"/>
                    <measurement group_id="O3" value="0.8" spread="0.1"/>
                    <measurement group_id="O4" value="0.9" spread="0.1"/>
                    <measurement group_id="O5" value="0.9" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="32"/>
                    <count group_id="O4" value="27"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.1"/>
                    <measurement group_id="O2" value="0.7" spread="0.1"/>
                    <measurement group_id="O3" value="0.8" spread="0.2"/>
                    <measurement group_id="O4" value="0.9" spread="0.2"/>
                    <measurement group_id="O5" value="1.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.0"/>
                    <measurement group_id="O2" value="0.7" spread="0.1"/>
                    <measurement group_id="O3" value="0.8" spread="0.2"/>
                    <measurement group_id="O4" value="0.8" spread="0.2"/>
                    <measurement group_id="O5" value="1.0" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject's Performance Index Measurement Over Time</title>
        <description>Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Performance Index is evaluated by echocardiography over time and are dependent on the size and type of the valve. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve.</description>
        <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
        <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 19mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O2">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 21mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O3">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 23mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O4">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 25mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O5">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 27mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve</description>
          </group>
        </group_list>
        <measure>
          <title>Subject's Performance Index Measurement Over Time</title>
          <description>Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Performance Index is evaluated by echocardiography over time and are dependent on the size and type of the valve. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve.</description>
          <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
          <units>Centimeters squared/meters squared</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="179"/>
                <count group_id="O3" value="291"/>
                <count group_id="O4" value="261"/>
                <count group_id="O5" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="257"/>
                    <count group_id="O4" value="200"/>
                    <count group_id="O5" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.1"/>
                    <measurement group_id="O2" value="0.9" spread="0.1"/>
                    <measurement group_id="O3" value="0.9" spread="0.1"/>
                    <measurement group_id="O4" value="0.9" spread="0.1"/>
                    <measurement group_id="O5" value="0.8" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="258"/>
                    <count group_id="O4" value="228"/>
                    <count group_id="O5" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.1"/>
                    <measurement group_id="O2" value="0.9" spread="0.1"/>
                    <measurement group_id="O3" value="0.9" spread="0.1"/>
                    <measurement group_id="O4" value="0.9" spread="0.1"/>
                    <measurement group_id="O5" value="0.8" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="256"/>
                    <count group_id="O4" value="214"/>
                    <count group_id="O5" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.1"/>
                    <measurement group_id="O2" value="0.9" spread="0.1"/>
                    <measurement group_id="O3" value="0.9" spread="0.1"/>
                    <measurement group_id="O4" value="0.9" spread="0.1"/>
                    <measurement group_id="O5" value="0.8" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="142"/>
                    <count group_id="O3" value="240"/>
                    <count group_id="O4" value="201"/>
                    <count group_id="O5" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.1"/>
                    <measurement group_id="O2" value="0.9" spread="0.1"/>
                    <measurement group_id="O3" value="0.9" spread="0.1"/>
                    <measurement group_id="O4" value="0.9" spread="0.1"/>
                    <measurement group_id="O5" value="0.8" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="122"/>
                    <count group_id="O3" value="220"/>
                    <count group_id="O4" value="177"/>
                    <count group_id="O5" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.1"/>
                    <measurement group_id="O2" value="0.9" spread="0.1"/>
                    <measurement group_id="O3" value="0.9" spread="0.1"/>
                    <measurement group_id="O4" value="0.9" spread="0.1"/>
                    <measurement group_id="O5" value="0.8" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="111"/>
                    <count group_id="O3" value="193"/>
                    <count group_id="O4" value="167"/>
                    <count group_id="O5" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.1"/>
                    <measurement group_id="O2" value="0.9" spread="0.1"/>
                    <measurement group_id="O3" value="0.9" spread="0.1"/>
                    <measurement group_id="O4" value="0.9" spread="0.1"/>
                    <measurement group_id="O5" value="0.8" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="150"/>
                    <count group_id="O4" value="130"/>
                    <count group_id="O5" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="0.1"/>
                    <measurement group_id="O2" value="0.9" spread="0.1"/>
                    <measurement group_id="O3" value="0.9" spread="0.1"/>
                    <measurement group_id="O4" value="0.9" spread="0.1"/>
                    <measurement group_id="O5" value="0.8" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="88"/>
                    <count group_id="O4" value="78"/>
                    <count group_id="O5" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="0.1"/>
                    <measurement group_id="O2" value="0.9" spread="0.1"/>
                    <measurement group_id="O3" value="0.8" spread="0.1"/>
                    <measurement group_id="O4" value="0.9" spread="0.1"/>
                    <measurement group_id="O5" value="0.8" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="32"/>
                    <count group_id="O4" value="27"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="0.1"/>
                    <measurement group_id="O2" value="0.9" spread="0.1"/>
                    <measurement group_id="O3" value="0.8" spread="0.1"/>
                    <measurement group_id="O4" value="0.9" spread="0.1"/>
                    <measurement group_id="O5" value="0.8" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="0.0"/>
                    <measurement group_id="O2" value="0.9" spread="0.1"/>
                    <measurement group_id="O3" value="0.8" spread="0.2"/>
                    <measurement group_id="O4" value="0.8" spread="0.1"/>
                    <measurement group_id="O5" value="0.8" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject's Cardiac Output Measurement at Over Time</title>
        <description>Cardiac output is the amount of blood the heart pumps through the circulatory system in a minute. Cardiac output is evaluated by echocardiography over time. Normal cardiac output in healthy volunteers over 60 years of age was reported between 3.1 and 6.4 liters per minute. In general, a higher value is considered better, and a lower value is considered worse.</description>
        <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
        <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 19mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O2">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 21mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O3">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 23mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O4">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 25mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O5">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 27mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject's Cardiac Output Measurement at Over Time</title>
          <description>Cardiac output is the amount of blood the heart pumps through the circulatory system in a minute. Cardiac output is evaluated by echocardiography over time. Normal cardiac output in healthy volunteers over 60 years of age was reported between 3.1 and 6.4 liters per minute. In general, a higher value is considered better, and a lower value is considered worse.</description>
          <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
          <units>Liters/minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="179"/>
                <count group_id="O3" value="291"/>
                <count group_id="O4" value="261"/>
                <count group_id="O5" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="162"/>
                    <count group_id="O3" value="261"/>
                    <count group_id="O4" value="207"/>
                    <count group_id="O5" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="0.9"/>
                    <measurement group_id="O2" value="4.6" spread="0.9"/>
                    <measurement group_id="O3" value="5.4" spread="1.1"/>
                    <measurement group_id="O4" value="5.6" spread="1.1"/>
                    <measurement group_id="O5" value="5.9" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="260"/>
                    <count group_id="O4" value="231"/>
                    <count group_id="O5" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="0.7"/>
                    <measurement group_id="O2" value="4.4" spread="0.8"/>
                    <measurement group_id="O3" value="5.0" spread="0.9"/>
                    <measurement group_id="O4" value="5.2" spread="1.0"/>
                    <measurement group_id="O5" value="5.4" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="259"/>
                    <count group_id="O4" value="220"/>
                    <count group_id="O5" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="0.9"/>
                    <measurement group_id="O2" value="4.4" spread="1.0"/>
                    <measurement group_id="O3" value="4.9" spread="0.9"/>
                    <measurement group_id="O4" value="5.1" spread="1.0"/>
                    <measurement group_id="O5" value="5.5" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="144"/>
                    <count group_id="O3" value="245"/>
                    <count group_id="O4" value="207"/>
                    <count group_id="O5" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="0.8"/>
                    <measurement group_id="O2" value="4.3" spread="0.8"/>
                    <measurement group_id="O3" value="4.9" spread="0.9"/>
                    <measurement group_id="O4" value="5.0" spread="1.0"/>
                    <measurement group_id="O5" value="5.3" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="124"/>
                    <count group_id="O3" value="226"/>
                    <count group_id="O4" value="185"/>
                    <count group_id="O5" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.7"/>
                    <measurement group_id="O2" value="4.3" spread="0.9"/>
                    <measurement group_id="O3" value="4.9" spread="0.9"/>
                    <measurement group_id="O4" value="5.1" spread="1.0"/>
                    <measurement group_id="O5" value="5.2" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="111"/>
                    <count group_id="O3" value="198"/>
                    <count group_id="O4" value="172"/>
                    <count group_id="O5" value="78"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="0.8"/>
                    <measurement group_id="O2" value="4.1" spread="0.8"/>
                    <measurement group_id="O3" value="4.9" spread="1.0"/>
                    <measurement group_id="O4" value="5.1" spread="1.0"/>
                    <measurement group_id="O5" value="5.2" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="92"/>
                    <count group_id="O3" value="157"/>
                    <count group_id="O4" value="141"/>
                    <count group_id="O5" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="0.7"/>
                    <measurement group_id="O2" value="4.3" spread="0.9"/>
                    <measurement group_id="O3" value="4.8" spread="1.0"/>
                    <measurement group_id="O4" value="5.0" spread="1.1"/>
                    <measurement group_id="O5" value="5.2" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="53"/>
                    <count group_id="O3" value="91"/>
                    <count group_id="O4" value="87"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="0.7"/>
                    <measurement group_id="O2" value="4.2" spread="0.9"/>
                    <measurement group_id="O3" value="4.9" spread="1.1"/>
                    <measurement group_id="O4" value="5.0" spread="1.1"/>
                    <measurement group_id="O5" value="5.3" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="34"/>
                    <count group_id="O4" value="27"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="0.6"/>
                    <measurement group_id="O2" value="4.2" spread="0.8"/>
                    <measurement group_id="O3" value="5.0" spread="1.0"/>
                    <measurement group_id="O4" value="5.1" spread="1.1"/>
                    <measurement group_id="O5" value="5.0" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="0.0"/>
                    <measurement group_id="O2" value="4.9" spread="1.6"/>
                    <measurement group_id="O3" value="5.4" spread="1.3"/>
                    <measurement group_id="O4" value="4.9" spread="1.3"/>
                    <measurement group_id="O5" value="5.5" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject's Cardiac Index Measurement Over Time</title>
        <description>Hemodynamic performance - Cardiac index (CI) evaluated by echocardiography. Cardiac index is an assessment of the cardiac output value based on the patient's size. To obtain the cardiac index, divide the cardiac output by the person's body surface area (BSA). Cardiac Index is a useful marker of how well the heart is functioning as a pump by directly correlating the volume of blood pumped by the heart with an individual's body surface area. Normal cardiac output index in healthy volunteers over 60 years of age was reported between 1.1 and 3.2 L/min/m^2. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient.</description>
        <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
        <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 19mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O2">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 21mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O3">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 23mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O4">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 25mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O5">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 27mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject's Cardiac Index Measurement Over Time</title>
          <description>Hemodynamic performance - Cardiac index (CI) evaluated by echocardiography. Cardiac index is an assessment of the cardiac output value based on the patient's size. To obtain the cardiac index, divide the cardiac output by the person's body surface area (BSA). Cardiac Index is a useful marker of how well the heart is functioning as a pump by directly correlating the volume of blood pumped by the heart with an individual's body surface area. Normal cardiac output index in healthy volunteers over 60 years of age was reported between 1.1 and 3.2 L/min/m^2. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient.</description>
          <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
          <units>Liters/minutes/meters squared</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="179"/>
                <count group_id="O3" value="291"/>
                <count group_id="O4" value="261"/>
                <count group_id="O5" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="260"/>
                    <count group_id="O4" value="206"/>
                    <count group_id="O5" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="0.5"/>
                    <measurement group_id="O2" value="2.4" spread="0.5"/>
                    <measurement group_id="O3" value="2.7" spread="0.5"/>
                    <measurement group_id="O4" value="2.6" spread="0.6"/>
                    <measurement group_id="O5" value="2.7" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="46"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="259"/>
                    <count group_id="O4" value="231"/>
                    <count group_id="O5" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="0.5"/>
                    <measurement group_id="O2" value="2.4" spread="0.4"/>
                    <measurement group_id="O3" value="2.5" spread="0.5"/>
                    <measurement group_id="O4" value="2.5" spread="0.5"/>
                    <measurement group_id="O5" value="2.5" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="161"/>
                    <count group_id="O3" value="259"/>
                    <count group_id="O4" value="216"/>
                    <count group_id="O5" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="0.6"/>
                    <measurement group_id="O2" value="2.4" spread="0.5"/>
                    <measurement group_id="O3" value="2.4" spread="0.4"/>
                    <measurement group_id="O4" value="2.4" spread="0.5"/>
                    <measurement group_id="O5" value="2.5" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="144"/>
                    <count group_id="O3" value="244"/>
                    <count group_id="O4" value="204"/>
                    <count group_id="O5" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="0.5"/>
                    <measurement group_id="O2" value="2.3" spread="0.4"/>
                    <measurement group_id="O3" value="2.4" spread="0.5"/>
                    <measurement group_id="O4" value="2.4" spread="0.5"/>
                    <measurement group_id="O5" value="2.4" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="124"/>
                    <count group_id="O3" value="226"/>
                    <count group_id="O4" value="185"/>
                    <count group_id="O5" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="0.4"/>
                    <measurement group_id="O2" value="2.3" spread="0.5"/>
                    <measurement group_id="O3" value="2.4" spread="0.4"/>
                    <measurement group_id="O4" value="2.4" spread="0.5"/>
                    <measurement group_id="O5" value="2.4" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="111"/>
                    <count group_id="O3" value="198"/>
                    <count group_id="O4" value="172"/>
                    <count group_id="O5" value="78"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="0.5"/>
                    <measurement group_id="O2" value="2.3" spread="0.4"/>
                    <measurement group_id="O3" value="2.4" spread="0.5"/>
                    <measurement group_id="O4" value="2.4" spread="0.5"/>
                    <measurement group_id="O5" value="2.4" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="92"/>
                    <count group_id="O3" value="157"/>
                    <count group_id="O4" value="140"/>
                    <count group_id="O5" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="0.5"/>
                    <measurement group_id="O2" value="2.3" spread="0.5"/>
                    <measurement group_id="O3" value="2.4" spread="0.5"/>
                    <measurement group_id="O4" value="2.3" spread="0.5"/>
                    <measurement group_id="O5" value="2.4" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="51"/>
                    <count group_id="O3" value="90"/>
                    <count group_id="O4" value="86"/>
                    <count group_id="O5" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="0.5"/>
                    <measurement group_id="O2" value="2.3" spread="0.4"/>
                    <measurement group_id="O3" value="2.4" spread="0.6"/>
                    <measurement group_id="O4" value="2.4" spread="0.6"/>
                    <measurement group_id="O5" value="2.4" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="34"/>
                    <count group_id="O4" value="27"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="0.4"/>
                    <measurement group_id="O2" value="2.2" spread="0.4"/>
                    <measurement group_id="O3" value="2.5" spread="0.5"/>
                    <measurement group_id="O4" value="2.4" spread="0.5"/>
                    <measurement group_id="O5" value="2.3" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="0.0"/>
                    <measurement group_id="O2" value="2.6" spread="0.9"/>
                    <measurement group_id="O3" value="2.6" spread="0.6"/>
                    <measurement group_id="O4" value="2.4" spread="0.6"/>
                    <measurement group_id="O5" value="2.8" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size</title>
        <description>Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. Higher numbers on the scale show a worsening outcome.</description>
        <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
        <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 19mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O2">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 21mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O3">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 23mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
          <group group_id="O4">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 25mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve</description>
          </group>
          <group group_id="O5">
            <title>Edwards INTUITY Surgical Aortic Heart Valve - 27mm</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve</description>
          </group>
        </group_list>
        <measure>
          <title>Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size</title>
          <description>Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. Higher numbers on the scale show a worsening outcome.</description>
          <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="179"/>
                <count group_id="O3" value="291"/>
                <count group_id="O4" value="261"/>
                <count group_id="O5" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="48"/>
                    <count group_id="O2" value="176"/>
                    <count group_id="O3" value="283"/>
                    <count group_id="O4" value="250"/>
                    <count group_id="O5" value="102"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>None (0)/Trival (+1)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="171"/>
                    <measurement group_id="O3" value="266"/>
                    <measurement group_id="O4" value="235"/>
                    <measurement group_id="O5" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild (+2)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="13"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate (+3)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe (+4)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="168"/>
                    <count group_id="O3" value="266"/>
                    <count group_id="O4" value="244"/>
                    <count group_id="O5" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>None (0)/Trival (+1)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="156"/>
                    <measurement group_id="O3" value="245"/>
                    <measurement group_id="O4" value="219"/>
                    <measurement group_id="O5" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild (+2)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="18"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate (+3)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe (+4)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="45"/>
                    <count group_id="O2" value="166"/>
                    <count group_id="O3" value="268"/>
                    <count group_id="O4" value="224"/>
                    <count group_id="O5" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>None (0)/Trival (+1)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="156"/>
                    <measurement group_id="O3" value="245"/>
                    <measurement group_id="O4" value="200"/>
                    <measurement group_id="O5" value="89"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild (+2)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="21"/>
                    <measurement group_id="O5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate (+3)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe (+4)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="146"/>
                    <count group_id="O3" value="252"/>
                    <count group_id="O4" value="217"/>
                    <count group_id="O5" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>None (0)/Trival (+1)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="138"/>
                    <measurement group_id="O3" value="229"/>
                    <measurement group_id="O4" value="193"/>
                    <measurement group_id="O5" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild (+2)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="19"/>
                    <measurement group_id="O4" value="23"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate (+3)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe (+4)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                    <count group_id="O2" value="127"/>
                    <count group_id="O3" value="232"/>
                    <count group_id="O4" value="197"/>
                    <count group_id="O5" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>None (0)/Trival (+1)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="120"/>
                    <measurement group_id="O3" value="211"/>
                    <measurement group_id="O4" value="179"/>
                    <measurement group_id="O5" value="79"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild (+2)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="18"/>
                    <measurement group_id="O5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate (+3)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe (+4)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="113"/>
                    <count group_id="O3" value="209"/>
                    <count group_id="O4" value="179"/>
                    <count group_id="O5" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>None (0)/Trival (+1)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="104"/>
                    <measurement group_id="O3" value="191"/>
                    <measurement group_id="O4" value="160"/>
                    <measurement group_id="O5" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild (+2)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="17"/>
                    <measurement group_id="O4" value="19"/>
                    <measurement group_id="O5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate (+3)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe (+4)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="161"/>
                    <count group_id="O4" value="149"/>
                    <count group_id="O5" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>None (0)/Trival (+1)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="87"/>
                    <measurement group_id="O3" value="146"/>
                    <measurement group_id="O4" value="129"/>
                    <measurement group_id="O5" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild (+2)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="18"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate (+3)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe (+4)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="97"/>
                    <count group_id="O4" value="88"/>
                    <count group_id="O5" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>None (0)/Trival (+1)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="53"/>
                    <measurement group_id="O3" value="87"/>
                    <measurement group_id="O4" value="78"/>
                    <measurement group_id="O5" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild (+2)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate (+3)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe (+4)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="35"/>
                    <count group_id="O4" value="29"/>
                    <count group_id="O5" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>None (0)/Trival (+1)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="30"/>
                    <measurement group_id="O4" value="22"/>
                    <measurement group_id="O5" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild (+2)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate (+3)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe (+4)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>None (0)/Trival (+1)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild (+2)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate (+3)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe (+4)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey</title>
        <description>The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states. The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worst health status.</description>
        <time_frame>Baseline and one year follow-up</time_frame>
        <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available at both the baseline and 1 year follow-up visits. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Edwards INTUITY Surgical Aortic Heart Valve</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey</title>
          <description>The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states. The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worst health status.</description>
          <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available at both the baseline and 1 year follow-up visits. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</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="524"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mental Health - Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.3" spread="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Health - 1 year follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.3" spread="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Health - Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.8" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Health - 1 year follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.6" spread="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Subject's Average White Blood Cell Count Over Time</title>
        <description>Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection. The normal reference range for WBC count is 4.5 to 10 10^3 cells/microliters. In general, results either lower or higher than the normal range can indicate something is wrong.</description>
        <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
        <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Edwards INTUITY Surgical Aortic Heart Valve</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject's Average White Blood Cell Count Over Time</title>
          <description>Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection. The normal reference range for WBC count is 4.5 to 10 10^3 cells/microliters. In general, results either lower or higher than the normal range can indicate something is wrong.</description>
          <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
          <units>10^3 cells/microliters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="885"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="878"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.54" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="825"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.27" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="800"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.31" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="751"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.47" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="690"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.47" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="629"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.41" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="512"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.37" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.47" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.05" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0" spread="36.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Subject's Average Red Blood Cell Count Over Time</title>
        <description>The red blood cell (RBC) count is a test that measures the number of oxygen-carrying blood cells in your blood. The red blood cell count normal range for women is 4.2 to 5.4 10^6 cells/microliters and for men is 4.7 to 6.1 10^6 cells/microliters. A high red blood cell count may indicate that you have a condition that's preventing you from getting enough oxygen. A low RBC may be caused by an infection, or a medical condition related to anemia. In general, results either lower or higher than the normal range can indicate something is wrong.</description>
        <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
        <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Edwards INTUITY Surgical Aortic Heart Valve</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject's Average Red Blood Cell Count Over Time</title>
          <description>The red blood cell (RBC) count is a test that measures the number of oxygen-carrying blood cells in your blood. The red blood cell count normal range for women is 4.2 to 5.4 10^6 cells/microliters and for men is 4.7 to 6.1 10^6 cells/microliters. A high red blood cell count may indicate that you have a condition that's preventing you from getting enough oxygen. A low RBC may be caused by an infection, or a medical condition related to anemia. In general, results either lower or higher than the normal range can indicate something is wrong.</description>
          <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
          <units>10^6 cells/microliters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="885"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="878"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.31" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="825"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.51" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="800"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.46" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="751"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.45" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="690"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.46" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="627"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.44" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="510"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.43" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.38" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.33" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.28" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Subject's Average Hematocrit Percentage Over Time</title>
        <description>Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. A hematocrit test measures the proportion of red blood cells in your blood. Red blood cells carry oxygen throughout your body. Having too few or too many red blood cells can be a sign of certain diseases. Normal hematocrit ranges for adult females are 36% to 44% and for adult males are 41% to 50%. In general, results either lower or higher than the normal range can indicate something is wrong.</description>
        <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
        <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Edwards INTUITY Surgical Aortic Heart Valve</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject's Average Hematocrit Percentage Over Time</title>
          <description>Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. A hematocrit test measures the proportion of red blood cells in your blood. Red blood cells carry oxygen throughout your body. Having too few or too many red blood cells can be a sign of certain diseases. Normal hematocrit ranges for adult females are 36% to 44% and for adult males are 41% to 50%. In general, results either lower or higher than the normal range can indicate something is wrong.</description>
          <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
          <units>Percentage of RBC</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="885"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="878"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.94" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="825"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.28" spread="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="800"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.25" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="751"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.30" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="689"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.42" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="629"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.40" spread="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="512"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.66" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.41" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.00" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.31" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Subject's Average Hemoglobin Percentage Over Time</title>
        <description>Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. In males, a healthy hemoglobin level is between 13.2 and 16.6 g/dL. In females, a hemoglobin count of between 11.6 and 15 g/dL is considered normal and healthy. In general, results either lower or higher than the normal range can indicate something is wrong.</description>
        <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
        <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Edwards INTUITY Surgical Aortic Heart Valve</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject's Average Hemoglobin Percentage Over Time</title>
          <description>Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. In males, a healthy hemoglobin level is between 13.2 and 16.6 g/dL. In females, a hemoglobin count of between 11.6 and 15 g/dL is considered normal and healthy. In general, results either lower or higher than the normal range can indicate something is wrong.</description>
          <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="885"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="878"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.95" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="826"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.82" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="800"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.33" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="752"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.37" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="690"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.42" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="630"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.39" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="511"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.22" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.20" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.10" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.87" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Subject's Average Plasma Free Hemoglobin Over Time</title>
        <description>Laboratory Analysis of Plasma Free Hemoglobin (Hgb) of blood drawn from subject. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood). The reference range for plasma free hemoglobin is 0.0 to 15.2 mg/dL. In general, values higher than this can indicate something is wrong.</description>
        <time_frame>Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up</time_frame>
        <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
        <group_list>
          <group group_id="O1">
            <title>Edwards INTUITY Surgical Aortic Heart Valve</title>
            <description>Subjects who received an INTUITY study surgical aortic heart valve.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject's Average Plasma Free Hemoglobin Over Time</title>
          <description>Laboratory Analysis of Plasma Free Hemoglobin (Hgb) of blood drawn from subject. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood). The reference range for plasma free hemoglobin is 0.0 to 15.2 mg/dL. In general, values higher than this can indicate something is wrong.</description>
          <population>This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve. Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="885"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Discharge</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="737"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.89" spread="14.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="708"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.12" spread="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 Year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="640"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.08" spread="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="518"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.06" spread="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="457"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.90" spread="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="411"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.88" spread="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="314"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.73" spread="16.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.32" spread="14.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.43" spread="14.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.61" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Events occurring from the day of aortic heart valve surgery up through 8 years post implant.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Edwards TRANSFORM INTUITY Aortic Valve Study Cohort</title>
          <description>The data from the 885 subjects who received the investigational Edwards INTUITY surgical aortic heart valve.</description>
        </group>
        <group group_id="E2">
          <title>Commercially Available Aortic Valve Study Cohort</title>
          <description>The data from the 49 subjects who received an alternate FDA approved surgical aortic heart valve.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="178" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="756" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANEMIA - BLEEDING RELATED - MAJOR</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ANEMIA - BLEEDING RELATED - MINOR</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ANEMIA - NON-BLEEDING RELATED</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>BLEEDING - CARDIOVASCULAR - MAJOR</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>BLEEDING - CARDIOVASCULAR - MINOR</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>BLEEDING - GASTROINTESTINAL LOWER - MAJOR</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>BLEEDING - GASTROINTESTINAL LOWER - MINOR</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>BLEEDING - GASTROINTESTINAL UPPER - MAJOR</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>BLEEDING - GASTROINTESTINAL UPPER - MINOR</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>BLEEDING - GENITOURINARY - MAJOR</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>BLEEDING - GENITOURINARY - MINOR</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>BLEEDING - MUSCULOSKELETAL/DERMATOLOGICAL - MAJOR (E.G. ECCHYMOSIS)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>BLEEDING - MUSCULOSKELETAL/DERMATOLOGICAL - MINOR (E.G. ECCHYMOSIS)</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>BLEEDING - NEUROLOGICAL - MAJOR (E.G. CVA)</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>BLEEDING - NEUROLOGICAL - MINOR (E.G. CVA)</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>BLEEDING - PERIPHERAL VASCULAR - MAJOR (E.G. NOSEBLEEDS; HEMATOMAS)</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>BLEEDING - PULMONARY/RESPIRATORY - MAJOR (E.G. HEMOTHORAX)</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>BLEEDING - PULMONARY/RESPIRATORY - MINOR (E.G. HEMOTHORAX)</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>BLOOD SEPSIS</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>BLOOD/LYMPHATIC - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>THROMBOCYTOPENIA - HEPARIN INDUCED (HIT)</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>THROMBOCYTOPENIA - NON-HEPARIN INDUCED</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ANGINA, STABLE</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ANGINA, UNSTABLE</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>AORTIC DISSECTION</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - ATRIAL FLUTTER</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - AV BLOCK - 1ST DEGREE</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - AV BLOCK - 2ND DEGREE</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - AV BLOCK - 3RD DEGREE</sub_title>
                <counts group_id="E1" subjects_affected="94" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - BRADYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - BUNDLE BRANCH BLOCK - LEFT</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - BUNDLE BRANCH BLOCK - RIGHT</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - PACEMAKER/ICD MALFUNCTION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)</sub_title>
                <counts group_id="E1" subjects_affected="91" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - PAROXYSMAL ATRIAL TACHYCARDIA (PAT)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - PERMANENT ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - PERSISTENT ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" subjects_affected="68" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - SUPRAVENTRICULAR TACHYCARDIA (SVT)</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - TACHY-BRADYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - TACHYCARDIA - NON-VENTRICULAR</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - TACHYCARDIA - VENTRICULAR</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - VENTRICULAR FIBRILLATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>CARDIAC ARREST</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>CARDIAC DECOMPENSATION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>CARDIOGENIC SHOCK</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>CARDIOVASCULAR - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="105" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>CORONARY ARTERY OSTIAL OBSTRUCTION</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ENDOCARDITIS</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>HEART FAILURE - ACUTE</sub_title>
                <counts group_id="E1" subjects_affected="64" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>HEART FAILURE - CHRONIC (CHF)</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>HYPERTENSION - SYSTEMIC</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>MYOCARDIAL INFARCTION</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>PERFORATION - VENTRICULAR</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>PERICARDIAL EFFUSION - MAJOR</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>PERICARDIAL EFFUSION - MINOR</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>PERICARDIAL TAMPONADE</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>PERICARDITIS</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>REGURGITATION - AORTIC-CENTRAL/TRANSVALVULAR +4</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>REGURGITATION - MITRAL-CENTRAL/TRANSVALVULAR +3</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>REGURGITATION - MITRAL-CENTRAL/TRANSVALVULAR +4</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>REGURGITATION - MITRAL-INDETERMINATE +3</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>REGURGITATION - MITRAL-INDETERMINATE +4</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>REGURGITATION - TRICUSPID-CENTRAL/TRANSVALVULAR +3</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>REGURGITATION - TRICUSPID-CENTRAL/TRANSVALVULAR +4</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>REGURGITATION - TRICUSPID-INDETERMINATE +3</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>REGURGITATION - TRICUSPID-INDETERMINATE +4</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>STENOSIS - MITRAL - SEVERE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>THROMBOEMBOLIC EVENT - OTHER - CENTRAL - NO PARESIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>THROMBOEMBOLIC EVENT - STROKE</sub_title>
                <counts group_id="E1" subjects_affected="56" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>THROMBOEMBOLIC EVENT - TRANSIENT ISCHEMIC ATTACK (TIA)</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>VALVE THROMBOSIS - AORTIC</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>PERFORATION - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>HEARING DISORDER</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>ENDOCRINE COMPLICATIONS</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>PANCREATIC COMPLICATION</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>VISION DISORDER</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>GASTROINTESTINAL - INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="108" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ALLERGIC REACTION - MEDICATION RELATED</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ALLERGIC REACTION - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ANAPHYLACTIC REACTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>CANCER - NEWLY DIAGNOSED</sub_title>
                <counts group_id="E1" subjects_affected="77" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>CANCER - PROGRESSION OF UNDERLYING DISEASE</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>FEVER - UNKNOWN ORIGIN</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>MULTI-SYSTEM ORGAN FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION</sub_title>
                <counts group_id="E1" subjects_affected="150" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>NSD - PARAVALVULAR LEAK +2</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>NSD - PARAVALVULAR LEAK +3</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>NSD - PARAVALVULAR LEAK +4</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>NSD - PARAVALVULAR LEAK WITH HEMOLYSIS</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>NSD - STUDY VALVE STENOSIS - SEVERE</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>SPEECH DISORDER</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>SVD - STUDY VALVE CALCIFICATION</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>BILIARY (GALLBLADDER)</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>HEPATIC COMPLICATION - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>LIVER FAILURE - ACUTE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>INFECTION/INFLAMMATION - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>STERNAL WOUND/THORACIC INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>WOUND INFECTION - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>METABOLIC COMPLICATIONS</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>BONE FRACTURE/BREAK</sub_title>
                <counts group_id="E1" subjects_affected="57" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>MUSCULAR SKELETAL/DERMATOLOGIC - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="177" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>PSYCHIATRIC - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>PSYCHIATRIC DISORDER</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>SUICIDE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>GENITOURINARY - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>RENAL - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>RENAL DYSFUNCTION</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>RENAL FAILURE - ACUTE</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>RENAL FAILURE - CHRONIC</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION (UTI)</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ATELECTASIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>HYPOXEMIA</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>PLEURAL EFFUSION - BILATERAL</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>PLEURAL EFFUSION - LEFT</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>PLEURAL EFFUSION - RIGHT</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>PNEUMOTHORAX</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>PULMONARY EDEMA</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>PULMONARY EMBOLISM - BILATERAL</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>PULMONARY EMBOLISM - LEFT</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>PULMONARY EMBOLISM - RIGHT</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>PULMONARY HYPERTENSION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>PULMONARY/RESPIRATORY - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>RESPIRATORY DYSFUNCTION/INSUFFICIENCY</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>RESPIRATORY FAILURE - ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS)</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>RESPIRATORY FAILURE - ASTHMA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>RESPIRATORY FAILURE - COPD</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>RESPIRATORY FAILURE - EMPHYSEMA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>RESPIRATORY FAILURE - HEMOTHORAX</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>RESPIRATORY FAILURE - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>RESPIRATORY FAILURE - PNEUMONIA</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>RESPIRATORY FAILURE - PNEUMOTHORAX</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>RESPIRATORY INFECTION - PNEUMONIA</sub_title>
                <counts group_id="E1" subjects_affected="69" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>RESPIRATORY INFECTION - UPPER (URI)</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>VASCULAR - ACCESS SITE COMPLICATION</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>VASCULAR - DEEP VEIN THROMBOSIS (DVT)</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>VASCULAR - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="868" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>THROMBOCYTOPENIA - NON-HEPARIN INDUCED</sub_title>
                <counts group_id="E1" subjects_affected="442" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>BLOOD/LYMPHATIC - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="259" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ANEMIA - BLEEDING RELATED - MINOR</sub_title>
                <counts group_id="E1" subjects_affected="196" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ANEMIA - NON-BLEEDING RELATED</sub_title>
                <counts group_id="E1" subjects_affected="83" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>THROMBOCYTOPENIA - HEPARIN INDUCED (HIT)</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)</sub_title>
                <counts group_id="E1" subjects_affected="262" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - BUNDLE BRANCH BLOCK - LEFT</sub_title>
                <counts group_id="E1" subjects_affected="279" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - AV BLOCK - 1ST DEGREE</sub_title>
                <counts group_id="E1" subjects_affected="232" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="248" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - BRADYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="137" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - BUNDLE BRANCH BLOCK - RIGHT</sub_title>
                <counts group_id="E1" subjects_affected="92" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" subjects_affected="161" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>CARDIOVASCULAR - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="154" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>HYPERTENSION - SYSTEMIC</sub_title>
                <counts group_id="E1" subjects_affected="80" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - ATRIAL FLUTTER</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - PERSISTENT ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>ARRHYTHMIA - TACHYCARDIA - NON-VENTRICULAR</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>HEART FAILURE - ACUTE</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>PERICARDITIS</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>ENDOCRINE COMPLICATIONS</sub_title>
                <counts group_id="E1" subjects_affected="61" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>VISION DISORDER</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>GASTROINTESTINAL - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="137" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION</sub_title>
                <counts group_id="E1" subjects_affected="253" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>INFECTION/INFLAMMATION - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="88" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>MUSCULAR SKELETAL/DERMATOLOGIC - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="234" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>BONE FRACTURE/BREAK</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>PSYCHIATRIC - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="77" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>URINARY TRACT INFECTION (UTI)</sub_title>
                <counts group_id="E1" subjects_affected="105" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>RENAL DYSFUNCTION</sub_title>
                <counts group_id="E1" subjects_affected="61" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>RENAL - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="59" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>RENAL FAILURE - ACUTE</sub_title>
                <counts group_id="E1" subjects_affected="57" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>GENITOURINARY - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ATELECTASIS</sub_title>
                <counts group_id="E1" subjects_affected="348" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>PLEURAL EFFUSION - BILATERAL</sub_title>
                <counts group_id="E1" subjects_affected="63" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>PULMONARY/RESPIRATORY - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="108" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="49"/>
              </event>
              <event>
                <sub_title>RESPIRATORY INFECTION - UPPER (URI)</sub_title>
                <counts group_id="E1" subjects_affected="60" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>VASCULAR - OTHER</sub_title>
                <counts group_id="E1" subjects_affected="57" subjects_at_risk="885"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="49"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>PI can't publish/present on overall study results not yet published but may publish his own data subject to EW review prior to submission/presentation, but data analyses of site-specific results can occur only in intervals as specified in the CTA. Publication/presentation of the PI's site-specific results of devices which haven't been market released and which still may be undergoing development, shall not include claims of device safety/effectiveness and will require the review/approval of EW.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jennifer Currin, Senior VP of Medical and Clinical Affairs, Surgical Structural Heart</name_or_title>
      <organization>Edwards Lifesciences, LLC</organization>
      <phone>949-250-2500</phone>
      <email>Jennifer_Currin@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/NCT01700439
org study id: 2011-02
nct id: NCT01700439
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
The purpose of the clinical study is to prove that the heart valve device is safe, effective,
      and performs as intended.
This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be
      enrolled at up to 35 centers in the US. After replacement of their aortic heart valve with
      the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the
      following intervals: discharge, 3 months, 1 year, and annually thereafter for a minimum of
      five years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the INTUTY Valve Implanted Cohort
time frame: Events occurring ≥ 31 days and up through 8 years post-implant
description: Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]
measure: Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success
time frame: Day of procedure
description: Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with maximum of two attempts and subject leaving the operating room (OR) with valve in place.
measure: Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success
time frame: Day of procedure through discharge or 10 days post index procedure, whichever comes first.
description: Procedural success is defined as device technical success followed by the absence of adverse events resulting in device reoperation implant of permanent pacemaker (with baseline sinus rhythm and no other pre-existing conduction issues), or valve-related death within discharge or 10 days post index procedure, whichever comes first.
measure: Average Amount of Time Subject Spent on Cardiopulmonary Bypass
time frame: Day of procedure
description: Surgical and hospitalization factors - Cardiopulmonary bypass time
measure: Average Subject Time on Cardiopulmonary Cross Clamp
time frame: Day of procedure
description: Surgical and hospitalization factors - Cardiopulmonary cross clamp time
measure: Average Number of Days Subjects Were in the Intensive Care Unit (ICU)
time frame: Day of procedure through discharge from the hospital
description: Length of time surgical subjects were in the intensive care unit (ICU) after their heart valve replacement procedure.
measure: Subject's New York Heart Association (NYHA) Classification Over Time
time frame: Baseline, 3-months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8 Years
description: The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity.
Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.
Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.
Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.
Symptoms of heart failure or the anginal syndrome may be present even at rest.
measure: Subject's Average Mean Gradient Measurements Over Time
time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up
description: Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.
measure: Subject's Average Peak Gradient Measurements Over Time
time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8-Years follow-up
description: Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.
measure: Subject's Effective Orifice Area (EOA) Measurement Over Time
time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
description: Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve.
measure: Subject's Effective Orifice Area Index (EOAI) Measurement Over Time
time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
description: Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the mitral valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve.
measure: Subject's Performance Index Measurement Over Time
time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
description: Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Performance Index is evaluated by echocardiography over time and are dependent on the size and type of the valve. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve.
measure: Subject's Cardiac Output Measurement at Over Time
time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
description: Cardiac output is the amount of blood the heart pumps through the circulatory system in a minute. Cardiac output is evaluated by echocardiography over time. Normal cardiac output in healthy volunteers over 60 years of age was reported between 3.1 and 6.4 liters per minute. In general, a higher value is considered better, and a lower value is considered worse.
measure: Subject's Cardiac Index Measurement Over Time
time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
description: Hemodynamic performance - Cardiac index (CI) evaluated by echocardiography. Cardiac index is an assessment of the cardiac output value based on the patient's size. To obtain the cardiac index, divide the cardiac output by the person's body surface area (BSA). Cardiac Index is a useful marker of how well the heart is functioning as a pump by directly correlating the volume of blood pumped by the heart with an individual's body surface area. Normal cardiac output index in healthy volunteers over 60 years of age was reported between 1.1 and 3.2 L/min/m^2. In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient.
measure: Amount of Aortic Valvular Regurgitation in Subjects Over Time by Valve Size
time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
description: Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. Higher numbers on the scale show a worsening outcome.
measure: Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey
time frame: Baseline and one year follow-up
description: The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states. The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worst health status.
measure: Subject's Average White Blood Cell Count Over Time
time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
description: Laboratory analysis of White Blood Cell (WBC) count on blood drawn from subject; WBC fight infection. The normal reference range for WBC count is 4.5 to 10 10^3 cells/microliters. In general, results either lower or higher than the normal range can indicate something is wrong.
measure: Subject's Average Red Blood Cell Count Over Time
time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
description: The red blood cell (RBC) count is a test that measures the number of oxygen-carrying blood cells in your blood. The red blood cell count normal range for women is 4.2 to 5.4 10^6 cells/microliters and for men is 4.7 to 6.1 10^6 cells/microliters. A high red blood cell count may indicate that you have a condition that's preventing you from getting enough oxygen. A low RBC may be caused by an infection, or a medical condition related to anemia. In general, results either lower or higher than the normal range can indicate something is wrong.
measure: Subject's Average Hematocrit Percentage Over Time
time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
description: Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. A hematocrit test measures the proportion of red blood cells in your blood. Red blood cells carry oxygen throughout your body. Having too few or too many red blood cells can be a sign of certain diseases. Normal hematocrit ranges for adult females are 36% to 44% and for adult males are 41% to 50%. In general, results either lower or higher than the normal range can indicate something is wrong.
measure: Subject's Average Hemoglobin Percentage Over Time
time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
description: Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells. In males, a healthy hemoglobin level is between 13.2 and 16.6 g/dL. In females, a hemoglobin count of between 11.6 and 15 g/dL is considered normal and healthy. In general, results either lower or higher than the normal range can indicate something is wrong.
measure: Subject's Average Plasma Free Hemoglobin Over Time
time frame: Discharge, 3 months, 1-, 2-, 3-, 4-, 5-, 6-, 7-, and 8- Years follow-up
description: Laboratory Analysis of Plasma Free Hemoglobin (Hgb) of blood drawn from subject. This blood test measures the level of free hemoglobin in the plasma (liquid portion of the blood). The reference range for plasma free hemoglobin is 0.0 to 15.2 mg/dL. In general, values higher than this can indicate something is wrong.
arm group label: EDWARDS INTUITY valve
arm group type: Experimental
description: All subjects enrolled into the study are implanted with the EDWARDS INTUITY Valve System.
intervention type: Device
intervention name: EDWARDS INTUITY valve
description: Surgical replacement of the aortic valve with the EDWARDS INTUITY valve.
arm group label: EDWARDS INTUITY valve
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Glenn Barnhart, MD
role: Principal Investigator
affiliation: Swedish Medical Center
last name: Walter Randolph Chitwood, MD
role: Principal Investigator
affiliation: East Carolina University
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country: United States
url: https://manual.jointcommission.org/releases/TJC2016A/DataElem0439.html
description: New York Heart Association Classification
citation: Barnhart GR, Accola KD, Grossi EA, Woo YJ, Mumtaz MA, Sabik JF, Slachman FN, Patel HJ, Borger MA, Garrett HE Jr, Rodriguez E, McCarthy PM, Ryan WH, Duhay FG, Mack MJ, Chitwood WR Jr; TRANSFORM Trial Investigators. TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve. J Thorac Cardiovasc Surg. 2017 Feb;153(2):241-251.e2. doi: 10.1016/j.jtcvs.2016.09.062. Epub 2016 Oct 15.
PMID: 27817951
citation: Romano MA, Koeckert M, Mumtaz MA, Slachman FN, Patel HJ, Chitwood WR Jr, Barnhart GR, Grossi EA; TRANSFORM Trial Investigators. Permanent Pacemaker Implantation After Rapid Deployment Aortic Valve Replacement. Ann Thorac Surg. 2018 Sep;106(3):685-690. doi: 10.1016/j.athoracsur.2018.03.055. Epub 2018 Apr 26.
PMID: 29705366
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
mesh term: Aortic Valve Insufficiency
mesh term: Constriction, Pathologic
sharing ipd: No
ipd description: Individual participant data will not be available to other researchers.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 