<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/NCT02232659</url>
  </required_header>
  <id_info>
    <org_study_id>SynCardia 70cc TAH-t for DT</org_study_id>
    <nct_id>NCT02232659</nct_id>
  </id_info>
  <brief_title>SynCardia 70cc TAH-t for Destination Therapy (DT)</brief_title>
  <acronym>RA-540</acronym>
  <official_title>SynCardia 70cc Temporary Total Artificial Heart (TAH-t) for Destination Therapy (DT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SynCardia Systems. LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SynCardia Systems. LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The SynCardia 70cc temporary Total Artificial Heart (TAH-t) is approved by the U.S. Food and&#xD;
      Drug Administration (FDA) for use as a bridge to transplant for patients at risk of imminent&#xD;
      (about to happen) death from irreversible biventricular heart failure.&#xD;
&#xD;
      The purpose of this research study is to evaluate whether the TAH-t can support patients with&#xD;
      life-threatening irreversible biventricular heart failure who are not eligible for&#xD;
      transplantation. The TAH-t, when used for patients who are not eligible for transplant, is&#xD;
      considered to be an investigational (not approved by FDA) use. This use is called destination&#xD;
      therapy (DT).&#xD;
&#xD;
      Nineteen (19) patients with life-threatening, biventricular failure who are not eligible for&#xD;
      cardiac transplant will be enrolled in the Primary Arm of the study and followed for up to&#xD;
      six months post-TAH-t implant. Safety will be evaluated by reviewing the adverse events that&#xD;
      are experienced by the enrolled subjects and comparing them to previous experience of TAH-t&#xD;
      patients who were waiting for a heart transplant. Since approximately 74% of patients with&#xD;
      this condition would not be expected to live beyond six months, the benefit of the TAH-t for&#xD;
      DT will be confirmed based on survival to six months without experiencing permanent disabling&#xD;
      stroke-related deficits. After the six month follow-up visit, patients will continue to be&#xD;
      followed under the study for up to five (5) years postTAH-t implant [every six months for up&#xD;
      to two years while supported with the TAH-t implant and then annually for another three&#xD;
      years].&#xD;
&#xD;
      Up to an additional 19 patients may be enrolled in the Secondary Arm of the study to further&#xD;
      characterize the use of the TAH-t for DT in a broader patient population. Follow-up would be&#xD;
      the same for patients enrolled in both arms of the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      On 15 October 2004, the SynCardia temporary Total Artificial Heart (TAH-t) received Food and&#xD;
      Drug Administration (FDA) approval (Premarket Approval Application [PMA] #P030011) for&#xD;
      in-hospital use as a bridge to transplant (BTT) in cardiac transplant-eligible candidates at&#xD;
      risk of imminent death from biventricular failure.&#xD;
&#xD;
      On 2 March 2012, FDA granted a Humanitarian Use Designation (HUD) to the 70cc TAH-t System&#xD;
      for use as Destination Therapy (DT) in patients at risk of imminent death from irreversible&#xD;
      biventricular heart failure who are not eligible for transplant and have a body surface area&#xD;
      (BSA) &gt;1.7m. This clinical study is intended to determine the safety and probable benefit of&#xD;
      the 70cc TAH-t for use in DT and support a Humanitarian Device Exemption (HDE) application&#xD;
      for this new indication for the TAH-t System.&#xD;
&#xD;
      The SynCardia TAH-t System is a pulsatile biventricular device that replaces a patient's&#xD;
      native ventricles and valves by pumping blood to both the pulmonary and systemic circulation.&#xD;
&#xD;
      The TAH-t System for DT consists of the implantable TAH-t with SynHall Valves, powered by&#xD;
      PMA-approved external pneumatic drivers [the Circulatory Support System (CSS) Console, the&#xD;
      Companion 2 Driver System and the Freedom Driver System]. The TAH-t System is intended to be&#xD;
      implanted in the operating room by a qualified surgeon and is capable of supporting the&#xD;
      patients both inside and outside the hospital.&#xD;
&#xD;
      The SynCardia TAH-t for DT is indicated for refractory advanced heart failure patients with&#xD;
      biventricular failure who are not candidates for cardiac transplant because of the presence&#xD;
      of contraindications to transplant, including cancer, advanced age, obesity, end-stage&#xD;
      diabetes mellitus, high panel reactive antibodies (PRAs), non-cardiac congenital defects,&#xD;
      contraindications to immunosuppression, lack of social support, poor medical compliance,&#xD;
      neurological impairment or other co-morbidities with a poor prognosis for survival. Patients&#xD;
      with life-threatening, irreversible biventricular failure who are not eligible for transplant&#xD;
      currently have no alternative but death.&#xD;
&#xD;
      The rationale for conducting this study is based on the results of clinical studies in the&#xD;
      bridge-to-transplant (BTT) patient population, together with the in vitro design verification&#xD;
      and validation testing, in vitro reliability testing, and clinical reliability experience of&#xD;
      more than thirty years.&#xD;
&#xD;
      The study design is a prospective, non-randomized, two-treatment arm, multi-center study.&#xD;
      Nineteen (19) patients will be enrolled in the Primary Arm at up to 30 investigational sites&#xD;
      to support an HDE for the use of the TAH-t as DT. Up to an additional 19 patients may be&#xD;
      enrolled in the Secondary Arm to futher characterize the use of the TAH-t for DT in a broader&#xD;
      patient population.&#xD;
&#xD;
      Patients treated with the 70cc TAH-t System for DT under the Primary Arm will be adult male&#xD;
      and female patients between the ages of 19 and 75 years old with a BSA ≥1.7m2 with&#xD;
      life-threatening irreversible biventricular failure who are not eligible for a heart&#xD;
      transplant (as determined by the implanting center at the time of implant assessment) and who&#xD;
      meet the enrollment criteria defined in the clinical protocol. Patients treated with the 70cc&#xD;
      TAH-t System for DT under the Secondary Arm will be adult male and female patients who are at&#xD;
      least 19 years old, are not eligible for a heart transplant (as determined by the implanting&#xD;
      center at the time of implant assessment), and who meet the less restrictive enrollment&#xD;
      criteria defined in the clinical protocol.&#xD;
&#xD;
      The risks to which the TAH-t subjects will be exposed in this clinical investigation are&#xD;
      expected to be no more than the well-characterized risks of the PMA-approved TAH-t System&#xD;
      when used for the bridge-to-transplant population and have been mitigated by the design and&#xD;
      testing of the TAH-t System.&#xD;
&#xD;
      The primary objective of the SynCardia temporary Total Artificial Heart (TAH-t) for DT Study&#xD;
      is to evaluate whether the TAH-t can support patients with life-threatening irreversible&#xD;
      biventricular heart failure who are ineligible for cardiac transplantation (as determined by&#xD;
      the implanting center at time of implant screening assessment), without experiencing&#xD;
      permanent disabling stroke-related deficits (as evidenced by a Modified Rankin Scale score of&#xD;
      0 - 2). The other primary objective of the study is to evaluate whether the safety profile of&#xD;
      the device, when used for DT, is acceptable.&#xD;
&#xD;
      Probable benefit is defined as survival to six months on TAH-t System support with the same&#xD;
      implanted TAH-t, without experiencing permanent disabling stroke-related deficits. This&#xD;
      patient population, without treatment, has a poor prognosis of survival. Per M.L.A. Haeck,&#xD;
      &quot;Patients with drug refractory end-stage HF [heart failure] receiving support with inotropic&#xD;
      drugs [have] a 3-, 6-, and 12-month survival of 51%, 26%, and 6%, respectively, with a mean&#xD;
      survival of only 3.4 months.&quot;1&#xD;
&#xD;
      The study success criteria are: alive on the original TAH-t and free from permanent disabling&#xD;
      stroke-related deficits (as evidenced by Modified Rankin Scale score of 0 - 2) at six months&#xD;
      post-implant (or transplanted prior to six months post-implant). For the study to be&#xD;
      considered a success, eight of the 19 subjects either must be alive at six months on the&#xD;
      original TAH-t implant, without experiencing a permanent disabling stroke deficit, or have&#xD;
      become transplant eligible (or have been transplanted).&#xD;
&#xD;
      The safety endpoints will be captured according to the Intermacs Registry AE definitions and&#xD;
      will be assessed according to the same data collection schedule followed under the Intermacs&#xD;
      Registry protocol. Secondary safety endpoints will be the incidences of major infection&#xD;
      (sepsis), neurological events (ischemic or hemorrhagic cardiovascular accident [CVA]),&#xD;
      chronic renal dysfunction, and the rate of major device failures/malfunctions, each defined&#xD;
      per the Intermacs definitions. A performance goal for each has been established based on the&#xD;
      previous experience of TAH-t patients who were waiting for a heart transplant.&#xD;
&#xD;
      All subjects will be followed in the study from the date of TAH-t implant until six months&#xD;
      post-implant, cardiac transplantation, death, or withdrawal from study, whichever occurs&#xD;
      first. Data from the six month post-TAH-t implant period will be used to support an HDE&#xD;
      application. After the six month follow-up visit, patients will continue to be followed under&#xD;
      the study for up to five (5) years post-TAH-t implant [every six months for up to two years&#xD;
      while supported with the TAH-t implant and then annually for another three years].&#xD;
&#xD;
      1 Neth Heart J (2012) 20:167-175 15 November 2011&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 2016</start_date>
  <completion_date type="Anticipated">May 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Probable Benefit</measure>
    <time_frame>Six Months</time_frame>
    <description>Alive on original TAH-t and free from permanent disabling stroke-related deficits (as evidenced by Modified Rankin Scale score of 0 - 2) at six months post-implant (or transplanted prior to six months post-implant).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>Six Months</time_frame>
    <description>Adverse Events (AEs) will be captured according to the Intermacs Registry AE definitions and will be assessed according to the same data collection schedule followed under the Intermacs Registry protocol for up to two years post-implant. In addition to reporting of rate, number and percent of subjects experiencing each adverse event, individual performance goals have been determined for four adverse event categories, based on the previous experience of patients supported by the TAH-t while awaiting cardiac transplant.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">38</enrollment>
  <condition>Life-threatening</condition>
  <condition>Biventricular Heart Failure</condition>
  <condition>Ineligible for Cardiac Transplant</condition>
  <arm_group>
    <arm_group_label>Primary Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of the SynCardia 70cc TAH-t for Destination Therapy to support an HDE Application.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Secondary Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of the SynCardia 70cc TAH-t for Destination Therapy in a less-restrictive patient population to further characterize the use of the 70cc TAH-t for DT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>70cc TAH-t for Destination Therapy</intervention_name>
    <description>Use of the approved SynCardia 70cc TAH-t for patients who are in biventricular failure (approved use), but who are ineligible for cardiac transplant (experimental use).</description>
    <arm_group_label>Primary Arm</arm_group_label>
    <arm_group_label>Secondary Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Primary Arm&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with ife-threatening, irreversible biventricular heart failure (Intermacs&#xD;
             Patient Profile Classifications 1 - 4)&#xD;
&#xD;
          2. Ineligible for cardiac transplantation (e.g., contraindication to immunosuppression,&#xD;
             cancer, elevated panel reactive antibodies [PRAs]) as determined by the implanting&#xD;
             center at time of implant screening assessment.&#xD;
&#xD;
          3. On optimal medical management and failing to respond or failing DT VAD therapy&#xD;
             (continuing to decline)&#xD;
&#xD;
          4. Ambulatory without assistance&#xD;
&#xD;
          5. Patients between 19 and 75 years of age&#xD;
&#xD;
          6. Patients with Body Surface Area (BSA) of ≥ 1.7m2&#xD;
&#xD;
          7. Sternum to T10 distance &gt; 10cm OR adequate room in chest as determined by 3-D imaging&#xD;
             assessment or by other standard clinical assessments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cardiac transplant-eligible patients&#xD;
&#xD;
          2. Patients who cannot be adequately anticoagulated on the TAH-t&#xD;
&#xD;
          3. Patients with insufficient space in the chest&#xD;
&#xD;
          4. Patients on ECMO support&#xD;
&#xD;
          5. Patients with Cirrhosis (evidenced by ultrasound, CT scan, or positive biopsy)&#xD;
&#xD;
          6. Patients with Acute or Chronic Renal dysfunction (per Intermacs AE Definitions)&#xD;
&#xD;
          7. Patients with cardiac cachexia (e.g., pre-albumin &lt;17, fragility, and&#xD;
             catabolic/anabolic imbalance)&#xD;
&#xD;
          8. Patients with a comorbidity that has a poor prognosis of survival beyond six months&#xD;
&#xD;
          9. Patients with insufficient social support or who have demonstrated non-compliance with&#xD;
             medical instructions (as determined by the Principal Investigator)&#xD;
&#xD;
        Secondary Arm&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who are NOT eligible to participate in the Primary Arm&#xD;
&#xD;
          2. Patients with life-threatening, irreversible biventricular heart failure (Intermacs&#xD;
             Patient Profile Classifications 1 - 7)&#xD;
&#xD;
          3. Ineligible for cardiac transplantation (as determined by the implanting center at time&#xD;
             of implant screening assessment).&#xD;
&#xD;
          4. On optimal medical management and failing to respond or failing DT VAD therapy&#xD;
             (continuing to decline)&#xD;
&#xD;
          5. Patients 19 years of age or older&#xD;
&#xD;
          6. Sternum to T10 distance &gt; 10cm OR adequate room in chest as determined by 3-D imaging&#xD;
             assessment or by other standard clinical assessments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who are less than 19 years old&#xD;
&#xD;
          2. Cardiac transplant-eligible patients&#xD;
&#xD;
          3. Patients with Cirrhosis (evidenced by ultrasound, CT scan, or positive biopsy)&#xD;
&#xD;
          4. Patients with Chronic Renal dysfunction (per Intermacs AE Definitions)&#xD;
&#xD;
          5. Patients with insufficient space in the chest&#xD;
&#xD;
          6. Patients who cannot be adequately anticoagulated on the TAH-t&#xD;
&#xD;
          7. Patients with insufficient social support or who have demonstrated non-compliance with&#xD;
             medical instructions (as determined by the Principal Investigator)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jack Copeland, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <overall_contact>
    <last_name>Judy Skroback, CIP, CRCP</last_name>
    <phone>520-545-1234</phone>
    <email>jskroback@syncardia.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Banner University Medical Center Phoenix</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Radha Gopalan, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Banner University Medical Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85726</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>David Bull, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Alfredo Trento, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Recruiting</status>
    <investigator>
      <last_name>Michael Sasevich, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Hermann Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Igor Gregoric, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Daniel Tang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Froedtert &amp; the Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>David Joyce, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>March 16, 2021</last_update_submitted>
  <last_update_submitted_qc>March 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SynCardia</keyword>
  <keyword>Total Artificial Heart</keyword>
  <keyword>Biventricular heart failure</keyword>
  <keyword>Ineligible for cardiac transplant</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/NCT02232659
org study id: SynCardia 70cc TAH-t for DT
nct id: NCT02232659
lead sponsor: 
has dmc: Yes
The SynCardia 70cc temporary Total Artificial Heart (TAH-t) is approved by the U.S. Food and
      Drug Administration (FDA) for use as a bridge to transplant for patients at risk of imminent
      (about to happen) death from irreversible biventricular heart failure.

      The purpose of this research study is to evaluate whether the TAH-t can support patients with
      life-threatening irreversible biventricular heart failure who are not eligible for
      transplantation. The TAH-t, when used for patients who are not eligible for transplant, is
      considered to be an investigational (not approved by FDA) use. This use is called destination
      therapy (DT).

      Nineteen (19) patients with life-threatening, biventricular failure who are not eligible for
      cardiac transplant will be enrolled in the Primary Arm of the study and followed for up to
      six months post-TAH-t implant. Safety will be evaluated by reviewing the adverse events that
      are experienced by the enrolled subjects and comparing them to previous experience of TAH-t
      patients who were waiting for a heart transplant. Since approximately 74% of patients with
      this condition would not be expected to live beyond six months, the benefit of the TAH-t for
      DT will be confirmed based on survival to six months without experiencing permanent disabling
      stroke-related deficits. After the six month follow-up visit, patients will continue to be
      followed under the study for up to five (5) years postTAH-t implant [every six months for up
      to two years while supported with the TAH-t implant and then annually for another three
      years].

      Up to an additional 19 patients may be enrolled in the Secondary Arm of the study to further
      characterize the use of the TAH-t for DT in a broader patient population. Follow-up would be
      the same for patients enrolled in both arms of the study.
On 15 October 2004, the SynCardia temporary Total Artificial Heart (TAH-t) received Food and
      Drug Administration (FDA) approval (Premarket Approval Application [PMA] #P030011) for
      in-hospital use as a bridge to transplant (BTT) in cardiac transplant-eligible candidates at
      risk of imminent death from biventricular failure.

      On 2 March 2012, FDA granted a Humanitarian Use Designation (HUD) to the 70cc TAH-t System
      for use as Destination Therapy (DT) in patients at risk of imminent death from irreversible
      biventricular heart failure who are not eligible for transplant and have a body surface area
      (BSA) >1.7m. This clinical study is intended to determine the safety and probable benefit of
      the 70cc TAH-t for use in DT and support a Humanitarian Device Exemption (HDE) application
      for this new indication for the TAH-t System.

      The SynCardia TAH-t System is a pulsatile biventricular device that replaces a patient's
      native ventricles and valves by pumping blood to both the pulmonary and systemic circulation.

      The TAH-t System for DT consists of the implantable TAH-t with SynHall Valves, powered by
      PMA-approved external pneumatic drivers [the Circulatory Support System (CSS) Console, the
      Companion 2 Driver System and the Freedom Driver System]. The TAH-t System is intended to be
      implanted in the operating room by a qualified surgeon and is capable of supporting the
      patients both inside and outside the hospital.

      The SynCardia TAH-t for DT is indicated for refractory advanced heart failure patients with
      biventricular failure who are not candidates for cardiac transplant because of the presence
      of contraindications to transplant, including cancer, advanced age, obesity, end-stage
      diabetes mellitus, high panel reactive antibodies (PRAs), non-cardiac congenital defects,
      contraindications to immunosuppression, lack of social support, poor medical compliance,
      neurological impairment or other co-morbidities with a poor prognosis for survival. Patients
      with life-threatening, irreversible biventricular failure who are not eligible for transplant
      currently have no alternative but death.

      The rationale for conducting this study is based on the results of clinical studies in the
      bridge-to-transplant (BTT) patient population, together with the in vitro design verification
      and validation testing, in vitro reliability testing, and clinical reliability experience of
      more than thirty years.

      The study design is a prospective, non-randomized, two-treatment arm, multi-center study.
      Nineteen (19) patients will be enrolled in the Primary Arm at up to 30 investigational sites
      to support an HDE for the use of the TAH-t as DT. Up to an additional 19 patients may be
      enrolled in the Secondary Arm to futher characterize the use of the TAH-t for DT in a broader
      patient population.

      Patients treated with the 70cc TAH-t System for DT under the Primary Arm will be adult male
      and female patients between the ages of 19 and 75 years old with a BSA ≥1.7m2 with
      life-threatening irreversible biventricular failure who are not eligible for a heart
      transplant (as determined by the implanting center at the time of implant assessment) and who
      meet the enrollment criteria defined in the clinical protocol. Patients treated with the 70cc
      TAH-t System for DT under the Secondary Arm will be adult male and female patients who are at
      least 19 years old, are not eligible for a heart transplant (as determined by the implanting
      center at the time of implant assessment), and who meet the less restrictive enrollment
      criteria defined in the clinical protocol.

      The risks to which the TAH-t subjects will be exposed in this clinical investigation are
      expected to be no more than the well-characterized risks of the PMA-approved TAH-t System
      when used for the bridge-to-transplant population and have been mitigated by the design and
      testing of the TAH-t System.

      The primary objective of the SynCardia temporary Total Artificial Heart (TAH-t) for DT Study
      is to evaluate whether the TAH-t can support patients with life-threatening irreversible
      biventricular heart failure who are ineligible for cardiac transplantation (as determined by
      the implanting center at time of implant screening assessment), without experiencing
      permanent disabling stroke-related deficits (as evidenced by a Modified Rankin Scale score of
      0 - 2). The other primary objective of the study is to evaluate whether the safety profile of
      the device, when used for DT, is acceptable.

      Probable benefit is defined as survival to six months on TAH-t System support with the same
      implanted TAH-t, without experiencing permanent disabling stroke-related deficits. This
      patient population, without treatment, has a poor prognosis of survival. Per M.L.A. Haeck,
      "Patients with drug refractory end-stage HF [heart failure] receiving support with inotropic
      drugs [have] a 3-, 6-, and 12-month survival of 51%, 26%, and 6%, respectively, with a mean
      survival of only 3.4 months."1

      The study success criteria are: alive on the original TAH-t and free from permanent disabling
      stroke-related deficits (as evidenced by Modified Rankin Scale score of 0 - 2) at six months
      post-implant (or transplanted prior to six months post-implant). For the study to be
      considered a success, eight of the 19 subjects either must be alive at six months on the
      original TAH-t implant, without experiencing a permanent disabling stroke deficit, or have
      become transplant eligible (or have been transplanted).

      The safety endpoints will be captured according to the Intermacs Registry AE definitions and
      will be assessed according to the same data collection schedule followed under the Intermacs
      Registry protocol. Secondary safety endpoints will be the incidences of major infection
      (sepsis), neurological events (ischemic or hemorrhagic cardiovascular accident [CVA]),
      chronic renal dysfunction, and the rate of major device failures/malfunctions, each defined
      per the Intermacs definitions. A performance goal for each has been established based on the
      previous experience of TAH-t patients who were waiting for a heart transplant.

      All subjects will be followed in the study from the date of TAH-t implant until six months
      post-implant, cardiac transplantation, death, or withdrawal from study, whichever occurs
      first. Data from the six month post-TAH-t implant period will be used to support an HDE
      application. After the six month follow-up visit, patients will continue to be followed under
      the study for up to five (5) years post-TAH-t implant [every six months for up to two years
      while supported with the TAH-t implant and then annually for another three years].

      1 Neth Heart J (2012) 20:167-175 15 November 2011
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Probable Benefit
time frame: Six Months
description: Alive on original TAH-t and free from permanent disabling stroke-related deficits (as evidenced by Modified Rankin Scale score of 0 - 2) at six months post-implant (or transplanted prior to six months post-implant).
measure: Safety
time frame: Six Months
description: Adverse Events (AEs) will be captured according to the Intermacs Registry AE definitions and will be assessed according to the same data collection schedule followed under the Intermacs Registry protocol for up to two years post-implant. In addition to reporting of rate, number and percent of subjects experiencing each adverse event, individual performance goals have been determined for four adverse event categories, based on the previous experience of patients supported by the TAH-t while awaiting cardiac transplant.
arm group label: Primary Arm
arm group type: Experimental
description: Use of the SynCardia 70cc TAH-t for Destination Therapy to support an HDE Application.
arm group label: Secondary Arm
arm group type: Experimental
description: Use of the SynCardia 70cc TAH-t for Destination Therapy in a less-restrictive patient population to further characterize the use of the 70cc TAH-t for DT.
intervention type: Device
intervention name: 70cc TAH-t for Destination Therapy
description: Use of the approved SynCardia 70cc TAH-t for patients who are in biventricular failure (approved use), but who are ineligible for cardiac transplant (experimental use).
arm group label: Primary Arm
arm group label: Secondary Arm
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Jack Copeland, MD
role: Principal Investigator
last name: Judy Skroback, CIP, CRCP
phone: 520-545-1234
email: jskroback@syncardia.com
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Heart Failure