<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/NCT02224755</url>
  </required_header>
  <id_info>
    <org_study_id>TC03062014</org_study_id>
    <nct_id>NCT02224755</nct_id>
  </id_info>
  <brief_title>MOMENTUM 3 IDE Clinical Study Protocol</brief_title>
  <acronym>HM3™</acronym>
  <official_title>Thoratec Corporation MOMENTUM 3, Multi-center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ IDE Clinical Study Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Thoratec Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by&#xD;
      demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of&#xD;
      advanced, refractory, left ventricular heart failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The HM3 LVAS is intended to provide hemodynamic support in patients with advanced, refractory&#xD;
      left ventricular heart failure; either for short term support, such as a bridge to cardiac&#xD;
      transplantation (BTT) or myocardial recovery, or as long term support, such as destination&#xD;
      therapy (DT). The HM3 is intended for use inside or outside the hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2014</start_date>
  <completion_date type="Actual">March 26, 2019</completion_date>
  <primary_completion_date type="Actual">September 28, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Short Term Primary End Point</measure>
    <time_frame>The first 294 randomized Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first.</time_frame>
    <description>Survival at 6 months free of disabling stroke (Modified Rankin Score &gt; 3) or reoperation to replace or remove a malfunctioning device</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Long Term Primary End Point</measure>
    <time_frame>The first 366 randomized Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.</time_frame>
    <description>Survival at 2 years free of disabling stroke (Modified Rankin Score &gt; 3) or reoperation to replace or remove a malfunctioning device</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Powered Secondary End Point: Pump Replacement at Two Years</measure>
    <time_frame>As they occur up to 24 months or to Outcome, whichever occurs first</time_frame>
    <description>In addition to powering the study on the primary endpoints for PMA approval, the study will pre-specify a powered secondary endpoint to evaluate incidence of pump replacements at 24 months. HeartMate II is the control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQoL 5D-5L (EQ-5D-5L) Total Score</measure>
    <time_frame>Baseline to 24 months</time_frame>
    <description>Quality of Life as measured by EuroQoL 5 Dimension-5 Level (EQ-5D-5L) total score. The EQ-5D-5L questionnaire has patients rate their quality of life across 5 categories of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scores from the 5 dimensions are summed for the total score which ranges from 5 to 25 with higher scores indicating more problems and a worse quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol-5D-5L Visual Analogue Scale</measure>
    <time_frame>Baseline to 24 months</time_frame>
    <description>Quality of life as measured by the visual analogue scale from the EuroQol-5D-5L questionnaire. The patient rates their current state of health with the visual analogue scale. The scale ranges from 0 to 100. Higher scores indicate a better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score</measure>
    <time_frame>Baseline to 24 months</time_frame>
    <description>Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six Minute Walk Test</measure>
    <time_frame>Baseline to 24 months</time_frame>
    <description>Functional status as measured by the Six Minute Walk Test. The Six Minute Walk Test measures the distance a patient is able to walk during 6 minutes without running or jogging.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New York Heart Association (NYHA) Classification</measure>
    <time_frame>Baseline to 24 months</time_frame>
    <description>Functional status as measured by NYHA classification. NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status. Class I indicates no limitation of physical activity. Class II indicates slight limitation of physical activity. Class IIIA indicates marked limitation of physical activity where less than ordinary physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IIIB indicates marked limitation of physical activity where mild physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IV indicates inability to carry on any physical activity without discomfort.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rehospitalizations</measure>
    <time_frame>From initial discharge to two years post-implant</time_frame>
    <description>Rate of all cause rehospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Event Rates</measure>
    <time_frame>Two years post-implant</time_frame>
    <description>Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1028</enrollment>
  <condition>Advanced Refractory Left Ventricular Heart Failure</condition>
  <arm_group>
    <arm_group_label>HeartMate 3 LVAS (HM3 LVAS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evaluation of the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HeartMate II LVAS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Evaluation of the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HeartMate 3 LVAS</intervention_name>
    <description>Implantation of HeartMate 3 LVAD to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure</description>
    <arm_group_label>HeartMate 3 LVAS (HM3 LVAS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HeartMate II LVAS</intervention_name>
    <description>Implantation of the commercially approved HeartMate II LVAD which is the standard treatment for advanced heart failure</description>
    <arm_group_label>HeartMate II LVAS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject or legal representative has signed Informed Consent Form (ICF)&#xD;
&#xD;
          2. Age ≥ 18 years&#xD;
&#xD;
          3. BSA ≥ 1.2 m2&#xD;
&#xD;
          4. NYHA Class III with dyspnea upon mild physical activity, or NYHA Class IV&#xD;
&#xD;
          5. LVEF ≤ 25%&#xD;
&#xD;
          6. a) Inotrope dependent OR b) CI &lt; 2.2 L/min/m2, while not on inotropes and subjects&#xD;
             must also meet one of the following:&#xD;
&#xD;
               -  On Optimal Medical Management (OMM), based on current heart failure practice&#xD;
                  guidelines for at least 45 out of the last 60 days and are failing to respond&#xD;
&#xD;
               -  Advanced Heart Failure for at least 14 days AND dependent on intra-aortic balloon&#xD;
                  pump (IABP) for at least 7 days&#xD;
&#xD;
          7. Females of child bearing age must agree to use adequate contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease,&#xD;
             obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive&#xD;
             cardiomyopathy&#xD;
&#xD;
          2. Technical obstacles which pose an inordinately high surgical risk, in the judgment of&#xD;
             the investigator&#xD;
&#xD;
          3. Existence of ongoing mechanical circulatory support (MCS) other than IABP&#xD;
&#xD;
          4. Positive pregnancy test if of childbearing potential&#xD;
&#xD;
          5. Presence of mechanical aortic valve that will not be either converted to a&#xD;
             bioprosthesis or oversewn at the time of LVAD implant&#xD;
&#xD;
          6. History of any organ transplant&#xD;
&#xD;
          7. Platelet count &lt; 100,000 x 103/L (&lt; 100,000/ml)&#xD;
&#xD;
          8. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial&#xD;
             issues that are likely to impair compliance with the study protocol and LVAS&#xD;
             management&#xD;
&#xD;
          9. History of confirmed, untreated AAA &gt; 5 cm in diameter within 6 months of enrollment&#xD;
&#xD;
         10. Presence of an active, uncontrolled infection&#xD;
&#xD;
         11. Intolerance to anticoagulant or antiplatelet therapies or any other&#xD;
             peri/post-operative therapy the investigator will require based upon the patients'&#xD;
             health status&#xD;
&#xD;
         12. Presence of any one of the following risk factors for indications of severe end organ&#xD;
             dysfunction or failure:&#xD;
&#xD;
               1. An INR ≥ 2.0 not due to anticoagulation therapy&#xD;
&#xD;
               2. Total bilirubin &gt; 43 umol/L (2.5 mg/dl), shock liver, or biopsy proven liver&#xD;
                  cirrhosis&#xD;
&#xD;
               3. History of severe chronic obstructive pulmonary disease (COPD) defined by&#xD;
                  FEV1/FVC &lt; 0.7, and FEV1 &lt;50% predicted&#xD;
&#xD;
               4. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is&#xD;
                  unresponsive to pharmacologic intervention&#xD;
&#xD;
               5. History of stroke within 90 days prior to enrollment, or a history of&#xD;
                  cerebrovascular disease with significant (&gt; 80%) uncorrected carotid stenosis&#xD;
&#xD;
               6. Serum creatinine ≥ 221 umol/L (2.5 mg/dl) or the need for chronic renal&#xD;
                  replacement therapy&#xD;
&#xD;
               7. Significant peripheral vascular disease (PVD) accompanied by rest pain or&#xD;
                  extremity ulceration&#xD;
&#xD;
         13. Patient has moderate to severe aortic insufficiency without plans for correction&#xD;
             during pump implant&#xD;
&#xD;
         14. Pre albumin &lt; 150 mg/L (15mg/dL) or Albumin &lt; 30g/L (3 g/dL) (if only one available) ;&#xD;
             pre albumin &lt; 150 mg/L (15mg/dL) and Albumin &lt; 30g/L (3 g/dL) (if both available)&#xD;
&#xD;
         15. Planned Bi-VAD support prior to enrollment&#xD;
&#xD;
         16. Patient has known hypo or hyper coagulable states such as disseminated intravascular&#xD;
             coagulation and heparin induced thrombocytopenia&#xD;
&#xD;
         17. Participation in any other clinical investigation that is likely to confound study&#xD;
             results or affect the study&#xD;
&#xD;
         18. Any condition other than HF that could limit survival to less than 24 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Crandall, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Abbott</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baptist Health Medical Center - Little Rock</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars Sinai Medical Center</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sutter Memorial Hospital</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sharp Memorial Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Pacific Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale New Haven Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedStar Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shands Hospital @ University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Hospital</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Heart Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Memorial Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advocate Christ Medical Center</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IU Health/Methodist Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky - Saha Cardiovascular Research Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish Hospital</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Unversity Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham &amp; Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum Health Butterworth Hospital</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abbott Northwestern Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota Medical Center, Fairview</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>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>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>63198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newark Beth Israel Medical Center</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mt. Sinai Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Medical Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals of Cleveland</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</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>Ohio State University Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>INTEGRIS Baptist Medical Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hershey</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</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>Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny General Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</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>15323</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Thomas West Hospital</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Research Institute</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hermann Health Systems</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Heart Institute</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah Hospital and Clinics</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Medical Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inova Fairfax Hospital</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara Norfolk General Hospital</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bon Secours St. Mary's Hospital</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Hospitals and Clinics</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>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>
  <reference>
    <citation>Mehra MR, Naka Y, Uriel N, Goldstein DJ, Cleveland JC Jr, Colombo PC, Walsh MN, Milano CA, Patel CB, Jorde UP, Pagani FD, Aaronson KD, Dean DA, McCants K, Itoh A, Ewald GA, Horstmanshof D, Long JW, Salerno C; MOMENTUM 3 Investigators. A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure. N Engl J Med. 2017 Feb 2;376(5):440-450. doi: 10.1056/NEJMoa1610426. Epub 2016 Nov 16.</citation>
    <PMID>27959709</PMID>
  </reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <results_first_submitted>October 2, 2019</results_first_submitted>
  <results_first_submitted_qc>October 30, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 20, 2019</results_first_posted>
  <last_update_submitted>June 23, 2022</last_update_submitted>
  <last_update_submitted_qc>June 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Heart Failure</keyword>
  <keyword>Left Ventricular Assist Device</keyword>
  <keyword>Ventricular Dysfunction</keyword>
  <keyword>Cardiomyopathy</keyword>
  <keyword>Heart Disease</keyword>
  <keyword>Cardiovascular Disease</keyword>
  <keyword>Heart-assist devices</keyword>
  <keyword>Thoratec Corporation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT02224755/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 22, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT02224755/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited at 69 study sites in the United States from 2014 to 2016.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>HeartMate II (Intent-to-Treat)</title>
          <description>Patients randomized to HeartMate II LVAS (control device)</description>
        </group>
        <group group_id="P2">
          <title>HeartMate 3 (Intent-to-Treat)</title>
          <description>Patients randomized to HeartMate 3 LVAS</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Randomization to Device Implant</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="512">Patients in the Full Study Cohort (n=1028) who were randomized to HeartMate II</participants>
                <participants group_id="P2" count="516">Patients in the Full Study Cohort (n=1028) who were randomized to HeartMate 3</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="505">Patients who underwent HeartMate II LVAS implant</participants>
                <participants group_id="P2" count="515">Patients who underwent HeartMate 3 LVAS implant</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawn prior to implant</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Two Year Follow up Post-implant</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="505"/>
                <participants group_id="P2" count="515"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="247"/>
                <participants group_id="P2" count="289"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="258"/>
                <participants group_id="P2" count="226"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="103"/>
                <participants group_id="P2" count="98"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Heart transplant</title>
              <participants_list>
                <participants group_id="P1" count="137"/>
                <participants group_id="P2" count="119"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Device explant or permanent deactivation</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawn post-implant</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>HeartMate II (Intent-to-Treat)</title>
          <description>Patients randomized to HeartMate II LVAS (control device)</description>
        </group>
        <group group_id="B2">
          <title>HeartMate 3 (Intent-to-Treat)</title>
          <description>Patients randomized to HeartMate 3 LVAS</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="512"/>
            <count group_id="B2" value="516"/>
            <count group_id="B3" value="1028"/>
          </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="60" spread="12"/>
                    <measurement group_id="B2" value="59" spread="12"/>
                    <measurement group_id="B3" value="60" spread="12"/>
                  </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="93"/>
                    <measurement group_id="B2" value="105"/>
                    <measurement group_id="B3" value="198"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="419"/>
                    <measurement group_id="B2" value="411"/>
                    <measurement group_id="B3" value="830"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race or ethnic group</title>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="367"/>
                    <measurement group_id="B2" value="342"/>
                    <measurement group_id="B3" value="709"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="120"/>
                    <measurement group_id="B2" value="145"/>
                    <measurement group_id="B3" value="265"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ischemic Cause of Heart Failure</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="240"/>
                    <measurement group_id="B2" value="216"/>
                    <measurement group_id="B3" value="456"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of Atrial Fibrillation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="238"/>
                    <measurement group_id="B2" value="215"/>
                    <measurement group_id="B3" value="453"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of Stroke</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Intended Goal of Support</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Bridge to transplantation</title>
                  <measurement_list>
                    <measurement group_id="B1" value="121"/>
                    <measurement group_id="B2" value="113"/>
                    <measurement group_id="B3" value="234"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bridge to candidacy for transplantation</title>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="167"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Destination therapy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="310"/>
                    <measurement group_id="B2" value="317"/>
                    <measurement group_id="B3" value="627"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Inotropes</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="423"/>
                    <measurement group_id="B2" value="445"/>
                    <measurement group_id="B3" value="868"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Implantable cardioverter-defibrillator</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="382"/>
                    <measurement group_id="B2" value="352"/>
                    <measurement group_id="B3" value="734"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Intra-aortic balloon pump</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>INTERMACS profile</title>
          <description>INTERMACS profiles describe the clinical profile of advanced heart failure patients who may be candidates for mechanical circulatory support. There are 7 profiles ranging from Profile 1 (most sick) to Profile 7 (least sick). Profile 1 indicates critical cardiogenic shock. Profile 2 indicates progressive decline. Profile 3 indicates stable but inotrope dependent. Profile 4 indicates resting symptoms. Profile 5 indicates exertion intolerant. Profile 6 indicates exertion limited. Profile 7 indicates advanced NYHA Class 3 (clinically stable with a reasonable level of comfortable activity).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="146"/>
                    <measurement group_id="B2" value="156"/>
                    <measurement group_id="B3" value="302"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="251"/>
                    <measurement group_id="B2" value="272"/>
                    <measurement group_id="B3" value="523"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="149"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5-7 or not provided</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Short Term Primary End Point</title>
        <description>Survival at 6 months free of disabling stroke (Modified Rankin Score &gt; 3) or reoperation to replace or remove a malfunctioning device</description>
        <time_frame>The first 294 randomized Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first.</time_frame>
        <population>First 294 randomized Subjects</population>
        <group_list>
          <group group_id="O1">
            <title>HeartMate II (Intent-to-Treat)</title>
            <description>Patients randomized to HeartMate II LVAS (control device)</description>
          </group>
          <group group_id="O2">
            <title>HeartMate 3 (Intent-to-Treat)</title>
            <description>Patients randomized to HeartMate 3 LVAS</description>
          </group>
        </group_list>
        <measure>
          <title>Short Term Primary End Point</title>
          <description>Survival at 6 months free of disabling stroke (Modified Rankin Score &gt; 3) or reoperation to replace or remove a malfunctioning device</description>
          <population>First 294 randomized Subjects</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="142"/>
                <count group_id="O2" value="152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109"/>
                    <measurement group_id="O2" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority would be demonstrated if the 95% lower confidence boundary for the difference between treatment groups (HM3 - HMII) in the occurrence of the primary end point would be greater than -10 percentage points, at a one-sided alpha level of 0.025 or a two-tailed P value of less than 0.05.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Farrington-Manning risk difference</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>9.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_lower_limit>-2.1</ci_lower_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Long Term Primary End Point</title>
        <description>Survival at 2 years free of disabling stroke (Modified Rankin Score &gt; 3) or reoperation to replace or remove a malfunctioning device</description>
        <time_frame>The first 366 randomized Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.</time_frame>
        <population>First 366 randomized Subjects</population>
        <group_list>
          <group group_id="O1">
            <title>HeartMate II (Intent-to-Treat)</title>
            <description>Patients randomized to HeartMate II LVAS (control device)</description>
          </group>
          <group group_id="O2">
            <title>HeartMate 3 (Intent-to-Treat)</title>
            <description>Patients randomized to HeartMate 3 LVAS</description>
          </group>
        </group_list>
        <measure>
          <title>Long Term Primary End Point</title>
          <description>Survival at 2 years free of disabling stroke (Modified Rankin Score &gt; 3) or reoperation to replace or remove a malfunctioning device</description>
          <population>First 366 randomized Subjects</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="176"/>
                <count group_id="O2" value="190"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106"/>
                    <measurement group_id="O2" value="151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority would be demonstrated if the 95% lower confidence boundary for the difference between treatment groups (HM3 - HMII) in the occurrence of the primary end point would be greater than -10 percentage points, at a one-sided alpha level of 0.025 or a two-tailed P value of less than 0.05.</non_inferiority_desc>
            <p_value>&lt;0.001</p_value>
            <method>Farrington-Manning risk difference</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>19.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_lower_limit>9.8</ci_lower_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Powered Secondary End Point: Pump Replacement at Two Years</title>
        <description>In addition to powering the study on the primary endpoints for PMA approval, the study will pre-specify a powered secondary endpoint to evaluate incidence of pump replacements at 24 months. HeartMate II is the control.</description>
        <time_frame>As they occur up to 24 months or to Outcome, whichever occurs first</time_frame>
        <population>All subjects who underwent implant with the assigned device</population>
        <group_list>
          <group group_id="O1">
            <title>HeartMate II (As-Treated)</title>
            <description>Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device</description>
          </group>
          <group group_id="O2">
            <title>HeartMate 3 (As-Treated)</title>
            <description>Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device</description>
          </group>
        </group_list>
        <measure>
          <title>Powered Secondary End Point: Pump Replacement at Two Years</title>
          <description>In addition to powering the study on the primary endpoints for PMA approval, the study will pre-specify a powered secondary endpoint to evaluate incidence of pump replacements at 24 months. HeartMate II is the control.</description>
          <population>All subjects who underwent implant with the assigned device</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="505"/>
                <count group_id="O2" value="515"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Based on data in the Sponsor's device tracking database, 7% of patients with the HeartMate II LVAS receive a pump replacement by 24 months. The expected proportion of patients with the HeartMate 3 LVAS to receive a pump replacement by 24 months was assumed to be 3%. We estimated that to demonstrate superiority of HeartMate 3 to HeartMate II with a power of 80% and α = 0.05 (2-sided), a total of 1028 patients (514 per arm) were required using the Fisher's exact test.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Fisher Exact</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>0.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>.11</ci_lower_limit>
            <ci_upper_limit>.38</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EuroQoL 5D-5L (EQ-5D-5L) Total Score</title>
        <description>Quality of Life as measured by EuroQoL 5 Dimension-5 Level (EQ-5D-5L) total score. The EQ-5D-5L questionnaire has patients rate their quality of life across 5 categories of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scores from the 5 dimensions are summed for the total score which ranges from 5 to 25 with higher scores indicating more problems and a worse quality of life.</description>
        <time_frame>Baseline to 24 months</time_frame>
        <population>Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment</population>
        <group_list>
          <group group_id="O1">
            <title>HeartMate II (As-Treated)</title>
            <description>Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device</description>
          </group>
          <group group_id="O2">
            <title>HeartMate 3 (As-Treated)</title>
            <description>Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device</description>
          </group>
        </group_list>
        <measure>
          <title>EuroQoL 5D-5L (EQ-5D-5L) Total Score</title>
          <description>Quality of Life as measured by EuroQoL 5 Dimension-5 Level (EQ-5D-5L) total score. The EQ-5D-5L questionnaire has patients rate their quality of life across 5 categories of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scores from the 5 dimensions are summed for the total score which ranges from 5 to 25 with higher scores indicating more problems and a worse quality of life.</description>
          <population>Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment</population>
          <units>score 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="505"/>
                <count group_id="O2" value="515"/>
              </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="475"/>
                    <count group_id="O2" value="486"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.2" spread="4.4"/>
                    <measurement group_id="O2" value="11.1" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="385"/>
                    <count group_id="O2" value="418"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" spread="3.2"/>
                    <measurement group_id="O2" value="8.5" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="227"/>
                    <count group_id="O2" value="275"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2" spread="3.8"/>
                    <measurement group_id="O2" value="8.8" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EuroQol-5D-5L Visual Analogue Scale</title>
        <description>Quality of life as measured by the visual analogue scale from the EuroQol-5D-5L questionnaire. The patient rates their current state of health with the visual analogue scale. The scale ranges from 0 to 100. Higher scores indicate a better quality of life.</description>
        <time_frame>Baseline to 24 months</time_frame>
        <population>Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment</population>
        <group_list>
          <group group_id="O1">
            <title>HeartMate II (As-Treated)</title>
            <description>Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device</description>
          </group>
          <group group_id="O2">
            <title>HeartMate 3 (As-Treated)</title>
            <description>Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device</description>
          </group>
        </group_list>
        <measure>
          <title>EuroQol-5D-5L Visual Analogue Scale</title>
          <description>Quality of life as measured by the visual analogue scale from the EuroQol-5D-5L questionnaire. The patient rates their current state of health with the visual analogue scale. The scale ranges from 0 to 100. Higher scores indicate a better quality of life.</description>
          <population>Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment</population>
          <units>score 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="505"/>
                <count group_id="O2" value="515"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baselline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="475"/>
                    <count group_id="O2" value="486"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48" spread="25"/>
                    <measurement group_id="O2" value="50" spread="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="386"/>
                    <count group_id="O2" value="420"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74" spread="19"/>
                    <measurement group_id="O2" value="76" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="227"/>
                    <count group_id="O2" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75" spread="19"/>
                    <measurement group_id="O2" value="76" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score</title>
        <description>Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.</description>
        <time_frame>Baseline to 24 months</time_frame>
        <population>Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment</population>
        <group_list>
          <group group_id="O1">
            <title>HeartMate II (As-Treated)</title>
            <description>Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device</description>
          </group>
          <group group_id="O2">
            <title>HeartMate 3 (As-Treated)</title>
            <description>Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device</description>
          </group>
        </group_list>
        <measure>
          <title>Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score</title>
          <description>Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.</description>
          <population>Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment</population>
          <units>score 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="505"/>
                <count group_id="O2" value="515"/>
              </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="482"/>
                    <count group_id="O2" value="493"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40" spread="23"/>
                    <measurement group_id="O2" value="39" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="388"/>
                    <count group_id="O2" value="421"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70" spread="21"/>
                    <measurement group_id="O2" value="70" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="227"/>
                    <count group_id="O2" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68" spread="23"/>
                    <measurement group_id="O2" value="69" spread="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Six Minute Walk Test</title>
        <description>Functional status as measured by the Six Minute Walk Test. The Six Minute Walk Test measures the distance a patient is able to walk during 6 minutes without running or jogging.</description>
        <time_frame>Baseline to 24 months</time_frame>
        <population>Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment. Patients unable to walk due to heart failure symptoms were assigned a distance of zero.</population>
        <group_list>
          <group group_id="O1">
            <title>HeartMate II (As-Treated)</title>
            <description>Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device</description>
          </group>
          <group group_id="O2">
            <title>HeartMate 3 (As-Treated)</title>
            <description>Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device</description>
          </group>
        </group_list>
        <measure>
          <title>Six Minute Walk Test</title>
          <description>Functional status as measured by the Six Minute Walk Test. The Six Minute Walk Test measures the distance a patient is able to walk during 6 minutes without running or jogging.</description>
          <population>Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment. Patients unable to walk due to heart failure symptoms were assigned a distance of zero.</population>
          <units>meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="505"/>
                <count group_id="O2" value="515"/>
              </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="452"/>
                    <count group_id="O2" value="471"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="129" spread="156"/>
                    <measurement group_id="O2" value="136" spread="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="333"/>
                    <count group_id="O2" value="365"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="327" spread="136"/>
                    <measurement group_id="O2" value="310" spread="142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                    <count group_id="O2" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="361" spread="337"/>
                    <measurement group_id="O2" value="323" spread="156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>New York Heart Association (NYHA) Classification</title>
        <description>Functional status as measured by NYHA classification. NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status. Class I indicates no limitation of physical activity. Class II indicates slight limitation of physical activity. Class IIIA indicates marked limitation of physical activity where less than ordinary physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IIIB indicates marked limitation of physical activity where mild physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IV indicates inability to carry on any physical activity without discomfort.</description>
        <time_frame>Baseline to 24 months</time_frame>
        <population>Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment</population>
        <group_list>
          <group group_id="O1">
            <title>HeartMate II (As-Treated)</title>
            <description>Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device</description>
          </group>
          <group group_id="O2">
            <title>HeartMate 3 (As-Treated)</title>
            <description>Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device</description>
          </group>
        </group_list>
        <measure>
          <title>New York Heart Association (NYHA) Classification</title>
          <description>Functional status as measured by NYHA classification. NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status. Class I indicates no limitation of physical activity. Class II indicates slight limitation of physical activity. Class IIIA indicates marked limitation of physical activity where less than ordinary physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IIIB indicates marked limitation of physical activity where mild physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IV indicates inability to carry on any physical activity without discomfort.</description>
          <population>Analysis population only includes patients still ongoing on LVAD support at the specified time periods who completed the assessment</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="505"/>
                <count group_id="O2" value="515"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Class I or II at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="504"/>
                    <count group_id="O2" value="514"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Class I or II at 6 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="392"/>
                    <count group_id="O2" value="428"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="310"/>
                    <measurement group_id="O2" value="340"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Class I or II at 24 Months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="229"/>
                    <count group_id="O2" value="275"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="176"/>
                    <measurement group_id="O2" value="219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rehospitalizations</title>
        <description>Rate of all cause rehospitalization</description>
        <time_frame>From initial discharge to two years post-implant</time_frame>
        <population>Analysis population only includes Subjects who were discharged on LVAD support from the implant hospitalization</population>
        <group_list>
          <group group_id="O1">
            <title>HeartMate II (As-Treated)</title>
            <description>Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device and were discharged on LVAD support</description>
          </group>
          <group group_id="O2">
            <title>HeartMate 3 (As-Treated)</title>
            <description>Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device and were discharged on LVAD support</description>
          </group>
        </group_list>
        <measure>
          <title>Rehospitalizations</title>
          <description>Rate of all cause rehospitalization</description>
          <population>Analysis population only includes Subjects who were discharged on LVAD support from the implant hospitalization</population>
          <units>events per patient year</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="471"/>
                <count group_id="O2" value="485"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.47"/>
                    <measurement group_id="O2" value="2.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Event Rates</title>
        <description>Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol</description>
        <time_frame>Two years post-implant</time_frame>
        <group_list>
          <group group_id="O1">
            <title>HeartMate II (As-Treated)</title>
            <description>Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device</description>
          </group>
          <group group_id="O2">
            <title>HeartMate 3 (As-Treated)</title>
            <description>Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Event Rates</title>
          <description>Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol</description>
          <units>events per patient year</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="505"/>
                <count group_id="O2" value="515"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Arterial Non-CNS Thromboembolism</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02"/>
                    <measurement group_id="O2" value="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.95"/>
                    <measurement group_id="O2" value="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiac Arrhythmia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.45"/>
                    <measurement group_id="O2" value="0.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hepatic Dysfunction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04"/>
                    <measurement group_id="O2" value="0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08"/>
                    <measurement group_id="O2" value="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Major Infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.82"/>
                    <measurement group_id="O2" value="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myocardial Infarction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01"/>
                    <measurement group_id="O2" value="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18"/>
                    <measurement group_id="O2" value="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemorrhagic Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07"/>
                    <measurement group_id="O2" value="0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ischemic Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11"/>
                    <measurement group_id="O2" value="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Debilitating Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07"/>
                    <measurement group_id="O2" value="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other Neurological Event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08"/>
                    <measurement group_id="O2" value="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pericardial Fluid Collection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07"/>
                    <measurement group_id="O2" value="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychiatric Episode</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07"/>
                    <measurement group_id="O2" value="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renal Dysfunction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08"/>
                    <measurement group_id="O2" value="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Respiratory Failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17"/>
                    <measurement group_id="O2" value="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right Heart Failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.23"/>
                    <measurement group_id="O2" value="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RVAD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03"/>
                    <measurement group_id="O2" value="0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Venous Thromboembolism</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04"/>
                    <measurement group_id="O2" value="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wound Dehiscence</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02"/>
                    <measurement group_id="O2" value="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Suspected Device Thrombosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12"/>
                    <measurement group_id="O2" value="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemolysis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01"/>
                    <measurement group_id="O2" value="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Two years post-implant</time_frame>
      <group_list>
        <group group_id="E1">
          <title>HeartMate II (As-Treated)</title>
          <description>Subjects randomized to HeartMate II LVAS who underwent implant with the assigned device</description>
        </group>
        <group group_id="E2">
          <title>HeartMate 3 (As-Treated)</title>
          <description>Subjects randomized to HeartMate 3 LVAS who underwent implant with the assigned device</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>Study Protocol</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="103" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="98" subjects_at_risk="515"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="466" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="483" subjects_at_risk="515"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Bleeding</sub_title>
                <counts group_id="E1" subjects_affected="271" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="214" subjects_at_risk="515"/>
              </event>
              <event>
                <sub_title>Hemolysis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="515"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="174" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="149" subjects_at_risk="515"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="515"/>
              </event>
              <event>
                <sub_title>Pericardial Fluid Collection</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="515"/>
              </event>
              <event>
                <sub_title>Right Heart Failure</sub_title>
                <counts group_id="E1" subjects_affected="127" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="151" subjects_at_risk="515"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Other</sub_title>
                <counts group_id="E1" subjects_affected="277" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="340" subjects_at_risk="515"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic Dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="515"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Major Infection</sub_title>
                <counts group_id="E1" subjects_affected="251" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="274" subjects_at_risk="515"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" subjects_affected="98" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="515"/>
              </event>
              <event>
                <sub_title>Other Neurological Event</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="59" subjects_at_risk="515"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Suspected Device Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="70" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="515"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric Episode</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="515"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="70" subjects_at_risk="515"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="94" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="110" subjects_at_risk="515"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Wound Dehiscence</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="515"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arterial Non-CNS Thromboembolism</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="515"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="515"/>
              </event>
              <event>
                <sub_title>Venous Thromboembolism</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="515"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>Study Protocol</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="235" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="261" subjects_at_risk="515"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Bleeding</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="515"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="46" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="54" subjects_at_risk="515"/>
              </event>
              <event>
                <sub_title>Right Heart Failure</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="515"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Other Adverse Event</sub_title>
                <counts group_id="E1" subjects_affected="113" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="139" subjects_at_risk="515"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Major Infection</sub_title>
                <counts group_id="E1" subjects_affected="79" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="95" subjects_at_risk="515"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric Episode</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="515"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="505"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="515"/>
              </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>MOMENTUM 3 has a study specific charter that governs the overall publication and presentation policy for all abstracts and manuscripts related to MOMENTUM 3 clinical data.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This was a non-blinded study</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Joyce Chuang/Principal scientist</name_or_title>
      <organization>Abbott</organization>
      <phone>925-353-5817</phone>
      <email>joyce.chuang@abbott.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/NCT02224755
org study id: TC03062014
nct id: NCT02224755
lead sponsor: 
collaborator: 
has dmc: Yes
The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by
      demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of
      advanced, refractory, left ventricular heart failure.
The HM3 LVAS is intended to provide hemodynamic support in patients with advanced, refractory
      left ventricular heart failure; either for short term support, such as a bridge to cardiac
      transplantation (BTT) or myocardial recovery, or as long term support, such as destination
      therapy (DT). The HM3 is intended for use inside or outside the hospital.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Short Term Primary End Point
time frame: The first 294 randomized Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first.
description: Survival at 6 months free of disabling stroke (Modified Rankin Score > 3) or reoperation to replace or remove a malfunctioning device
measure: Long Term Primary End Point
time frame: The first 366 randomized Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first.
description: Survival at 2 years free of disabling stroke (Modified Rankin Score > 3) or reoperation to replace or remove a malfunctioning device
measure: Powered Secondary End Point: Pump Replacement at Two Years
time frame: As they occur up to 24 months or to Outcome, whichever occurs first
description: In addition to powering the study on the primary endpoints for PMA approval, the study will pre-specify a powered secondary endpoint to evaluate incidence of pump replacements at 24 months. HeartMate II is the control.
measure: EuroQoL 5D-5L (EQ-5D-5L) Total Score
time frame: Baseline to 24 months
description: Quality of Life as measured by EuroQoL 5 Dimension-5 Level (EQ-5D-5L) total score. The EQ-5D-5L questionnaire has patients rate their quality of life across 5 categories of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scores from the 5 dimensions are summed for the total score which ranges from 5 to 25 with higher scores indicating more problems and a worse quality of life.
measure: EuroQol-5D-5L Visual Analogue Scale
time frame: Baseline to 24 months
description: Quality of life as measured by the visual analogue scale from the EuroQol-5D-5L questionnaire. The patient rates their current state of health with the visual analogue scale. The scale ranges from 0 to 100. Higher scores indicate a better quality of life.
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
time frame: Baseline to 24 months
description: Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100. Higher scores indicate better quality of life and fewer heart failure symptoms.
measure: Six Minute Walk Test
time frame: Baseline to 24 months
description: Functional status as measured by the Six Minute Walk Test. The Six Minute Walk Test measures the distance a patient is able to walk during 6 minutes without running or jogging.
measure: New York Heart Association (NYHA) Classification
time frame: Baseline to 24 months
description: Functional status as measured by NYHA classification. NYHA class categorizes patients by the severity of their heart failure symptoms. As the class increases, the degree of symptoms is more severe indicating worse functional status. Class I indicates no limitation of physical activity. Class II indicates slight limitation of physical activity. Class IIIA indicates marked limitation of physical activity where less than ordinary physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IIIB indicates marked limitation of physical activity where mild physical activity causes fatigue, palpitation, dyspnea, or angina pain. Class IV indicates inability to carry on any physical activity without discomfort.
measure: Rehospitalizations
time frame: From initial discharge to two years post-implant
description: Rate of all cause rehospitalization
measure: Adverse Event Rates
time frame: Two years post-implant
description: Events-per-patient-year (EPPY) for anticipated adverse events as defined in the study protocol
arm group label: HeartMate 3 LVAS (HM3 LVAS)
arm group type: Experimental
description: Evaluation of the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
arm group label: HeartMate II LVAS
arm group type: Active Comparator
description: Evaluation of the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
intervention type: Device
intervention name: HeartMate 3 LVAS
description: Implantation of HeartMate 3 LVAD to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure
arm group label: HeartMate 3 LVAS (HM3 LVAS)
intervention type: Device
intervention name: HeartMate II LVAS
description: Implantation of the commercially approved HeartMate II LVAD which is the standard treatment for advanced heart failure
arm group label: HeartMate II LVAS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Daniel Crandall, PhD
role: Study Director
affiliation: Abbott
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country: United States
citation: Mehra MR, Naka Y, Uriel N, Goldstein DJ, Cleveland JC Jr, Colombo PC, Walsh MN, Milano CA, Patel CB, Jorde UP, Pagani FD, Aaronson KD, Dean DA, McCants K, Itoh A, Ewald GA, Horstmanshof D, Long JW, Salerno C; MOMENTUM 3 Investigators. A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure. N Engl J Med. 2017 Feb 2;376(5):440-450. doi: 10.1056/NEJMoa1610426. Epub 2016 Nov 16.
PMID: 27959709
responsible party type: Sponsor
mesh term: Heart Failure
provided document: 
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reported events: 
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limitations and caveats: This was a non-blinded study
point of contact: 