<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/NCT02205411</url>
  </required_header>
  <id_info>
    <org_study_id>CAP00030</org_study_id>
    <nct_id>NCT02205411</nct_id>
  </id_info>
  <brief_title>Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation</brief_title>
  <official_title>A Prospective, Randomized, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of the HeartAssist 5® VAD System Compared to the Thoratec HeartMate II® VAD and HeartWare® HVAD for Left Ventricular Support in Patients Awaiting Cardiac Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ReliantHeart Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ReliantHeart Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the safety and effectiveness of the ReliantHeart&#xD;
      HeartAssist 5® VAD System in patients listed for heart transplantation and at risk of death&#xD;
      from refractory end-stage heart failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The HeartAssist 5® VAD System is intended for use as a bridge to heart transplantation and&#xD;
      will be compared to the HeartMate II and HVAD devices.&#xD;
&#xD;
      Patients that meet the study criteria will be randomized 1:1 to either the HeartAssist 5® VAD&#xD;
      System (treatment group) or control group (HeartMate II and HVAD). The physician will have&#xD;
      the option to choose which control device to implant.&#xD;
&#xD;
      The primary objective of the study is to show non-inferiority of the HeartAssist 5®&#xD;
      (treatment group) to the control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Inability to timely enroll.&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 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>The primary endpoint is success at 180 days</measure>
    <time_frame>180 days</time_frame>
    <description>Success at 180 days is defined as alive on the original device, transplanted or explanted for heart recovery and alive 60 days after device explant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>180 days</time_frame>
    <description>Device safety will be reported as the frequency of each adverse event, (including device failure, device malfunction or unanticipated adverse device effects) and the rate of adverse events per patient year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>180 days</time_frame>
    <description>Quality of life data, as measured by the EuroQol (EQ-5D) will be summarized and analyzed, for both groups, comparing data at baseline and study intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Status</measure>
    <time_frame>180 days</time_frame>
    <description>NYHA and six-minute walk analysis will be reported by group for data at pre-implant and at study-defined intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurologic Status</measure>
    <time_frame>180 days</time_frame>
    <description>Evaluation of any change in Modified Rankin Scale from baseline to 180-days post-implant or device explant.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Heart Failure</condition>
  <condition>Cardiac Failure</condition>
  <condition>Congestive Heart Failure</condition>
  <condition>Heart Failure, Left-sided</condition>
  <arm_group>
    <arm_group_label>HeartAssist 5® VAD System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implant of the HeartAssist 5® VAD System</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control VAD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HeartAssist 5® VAD System</intervention_name>
    <description>The HeartAssist 5® VAD System is a small, implantable pump that is designed to increase blood flow for patients who have heart failure. The device is intended to support patients in the hospital or at home.</description>
    <arm_group_label>HeartAssist 5® VAD System</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control VAD</intervention_name>
    <description>The HeartMate II® VAD or HVAD®</description>
    <arm_group_label>Control VAD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Able to sign Informed Consent.&#xD;
&#xD;
          2. Age ≥ 18&#xD;
&#xD;
          3. Body Surface Area (BSA) ≥ 1.2 m2.&#xD;
&#xD;
          4. Cardiac transplant candidate, defined as: Listed for cardiac transplant, and&#xD;
             designated by the institution's multidisciplinary transplant committee as appropriate&#xD;
             forLVAD Bridge-to-Transplantation therapy, or Designated by the institutions's&#xD;
             multidisciplinary transplant committee as: 1) an appropriate candidate for LVAD&#xD;
             Bridge-to transplant therapy, and 2) An inappropriate candidate for LVAD destination&#xD;
             therapy&#xD;
&#xD;
          5. LVAD implantation has been approved by the institution's multidisciplinary transplant&#xD;
             committee.&#xD;
&#xD;
          6. Patient is NYHA Class IV.&#xD;
&#xD;
          7. Able to return to the clinical site for all routine follow up visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cardiothoracic surgery within 30 days prior to enrollment.&#xD;
&#xD;
          2. Acute Myocardial Infarction within 14 days prior to enrollment.&#xD;
&#xD;
          3. Prior cardiac transplantation, left ventricular reduction surgery, cardiomyoplasty or&#xD;
             left ventricular assist device.&#xD;
&#xD;
          4. Mechanical, animal, or human tissue heart valve.&#xD;
&#xD;
          5. History of untreated abdominal or thoracic aortic aneurysm &gt; 5 cm.&#xD;
&#xD;
          6. On ventilator support for &gt; 72 hours within four days immediately prior to enrollment.&#xD;
&#xD;
          7. Ongoing mechanical circulatory support other than an intra-aortic balloon pump (IABP).&#xD;
&#xD;
          8. Proven history of pulmonary embolism within 90 days of enrollment.&#xD;
&#xD;
          9. Moderate to severe aortic insufficiency as determined by echocardiogram without plans&#xD;
             for correction during pump implantation surgery.&#xD;
&#xD;
         10. Requires aortic, mitral, tricuspid or pulmonary valve replacements (including&#xD;
             Bioprosthetic valves) or left ventricular (LV) aneurysm resection.&#xD;
&#xD;
         11. Uncorrected thrombocytopenia or generalized coagulopathy (e.g., platelets &lt;100,000,&#xD;
             INR &gt; 1.6 or PTT &gt; 2.5 times control in the absence of anticoagulation therapy)&#xD;
&#xD;
         12. Severe right ventricular failure as defined by the anticipated need for right&#xD;
             ventricular assist device (RVAD) support OR extracorporeal membrane oxygenation (ECMO)&#xD;
             at the time of implantation OR right atrial pressure &gt; 20 mmHg while on multiple&#xD;
             inotropes.&#xD;
&#xD;
         13. Significant renal dysfunction defined as &gt; 3.5 mg/dl or requires hemo or peritoneal&#xD;
             dialysis for renal failure (excluding ultra-filtration for fluid removal).&#xD;
&#xD;
         14. Evidence of intrinsic hepatic disease defined as liver enzyme values (AST, ALT and LDH&#xD;
             that are &gt; 3 times the upper limit of normal) OR a total bilirubin &gt; 3 mg/dl OR biopsy&#xD;
             proven liver cirrhosis or portal hypertension.&#xD;
&#xD;
         15. Pregnancy&#xD;
&#xD;
         16. Active systemic infection prior to study enrollment not yet resolved by treatment.&#xD;
             Active Systemic Infection is defined by any one of the following in spite of&#xD;
             antibiotic, antiviral or antifungal treatment: 2 or more consecutive positive&#xD;
             cultures; elevated temperature &gt; 37.2 (°C) and white blood cell count &gt; 11.0 (103/ml);&#xD;
             hypotension, tachycardia and generalized malaise.&#xD;
&#xD;
         17. Stroke within 90 days prior to enrollment OR patient has a history of cerebral&#xD;
             vascular disease with &gt; 80% extra cranial stenosis documented by carotid Doppler study&#xD;
             during transplant evaluation&#xD;
&#xD;
         18. Modified Rankin Scale score of ≥ 2 or has any neurologic disability as confirmed by&#xD;
             imaging (CT or MRI).&#xD;
&#xD;
         19. Significant lower extremity peripheral vascular disease accompanied by rest pain or&#xD;
             leg ulceration.&#xD;
&#xD;
         20. Intolerant to anticoagulant or antiplatelet therapies or any other peri- or&#xD;
             postoperative therapy that the investigator may administer based upon the patient's&#xD;
             health status.&#xD;
&#xD;
         21. Psychiatric disorder, or other psychosocial behavior that is likely to impair&#xD;
             compliance with the study protocol.&#xD;
&#xD;
         22. Receiving therapy with an investigational intervention or participating in any other&#xD;
             clinical investigation at the time of enrollment.&#xD;
&#xD;
         23. Condition, other than heart failure, that may limit survival to less than three (3)&#xD;
             years and/or would exclude cardiac transplantation.&#xD;
&#xD;
         24. Unwilling or unable to comply with any study requirement.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Stanford</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33146</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>Indiana University Health, Inc. d/b/a Methodist Research Institute</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent Hospital &amp; Health Care Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</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>Minneapolis Heart Institute Foundation</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Hospital - Saint Mary's Campus</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI St. Luke's Baylor College of Medicine Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Sacred Heart Hospital</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>July 16, 2018</last_update_submitted>
  <last_update_submitted_qc>July 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>heart assist device</keyword>
  <keyword>ventricular assist device</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02205411
org study id: CAP00030
nct id: NCT02205411
lead sponsor: 
has dmc: Yes
The purpose of the study is to evaluate the safety and effectiveness of the ReliantHeart
      HeartAssist 5® VAD System in patients listed for heart transplantation and at risk of death
      from refractory end-stage heart failure.
The HeartAssist 5® VAD System is intended for use as a bridge to heart transplantation and
      will be compared to the HeartMate II and HVAD devices.

      Patients that meet the study criteria will be randomized 1:1 to either the HeartAssist 5® VAD
      System (treatment group) or control group (HeartMate II and HVAD). The physician will have
      the option to choose which control device to implant.

      The primary objective of the study is to show non-inferiority of the HeartAssist 5®
      (treatment group) to the control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The primary endpoint is success at 180 days
time frame: 180 days
description: Success at 180 days is defined as alive on the original device, transplanted or explanted for heart recovery and alive 60 days after device explant.
measure: Adverse Events
time frame: 180 days
description: Device safety will be reported as the frequency of each adverse event, (including device failure, device malfunction or unanticipated adverse device effects) and the rate of adverse events per patient year.
measure: Quality of Life
time frame: 180 days
description: Quality of life data, as measured by the EuroQol (EQ-5D) will be summarized and analyzed, for both groups, comparing data at baseline and study intervals.
measure: Functional Status
time frame: 180 days
description: NYHA and six-minute walk analysis will be reported by group for data at pre-implant and at study-defined intervals.
measure: Neurologic Status
time frame: 180 days
description: Evaluation of any change in Modified Rankin Scale from baseline to 180-days post-implant or device explant.
arm group label: HeartAssist 5® VAD System
arm group type: Experimental
description: Implant of the HeartAssist 5® VAD System
arm group label: Control VAD
arm group type: Active Comparator
intervention type: Device
intervention name: HeartAssist 5® VAD System
description: The HeartAssist 5® VAD System is a small, implantable pump that is designed to increase blood flow for patients who have heart failure. The device is intended to support patients in the hospital or at home.
arm group label: HeartAssist 5® VAD System
intervention type: Device
intervention name: Control VAD
description: The HeartMate II® VAD or HVAD®
arm group label: Control VAD
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Failure