<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/NCT03836079</url>
  </required_header>
  <id_info>
    <org_study_id>101773-002</org_study_id>
    <nct_id>NCT03836079</nct_id>
  </id_info>
  <brief_title>SVC Occlusion in Subjects With Acute Decompensated Heart Failure</brief_title>
  <acronym>VENUS-HF</acronym>
  <official_title>Superior Vena Caval Occlusion in Subjects With Acute Decompensated Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abiomed Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abiomed Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Safety and performance evaluation of the preCARDIA System for patients with ADHF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this early feasibility study is to evaluate the safety and performance of&#xD;
      the preCARDIA System for Superior Vena Caval (SVC) intermittent mechanical occlusion as a&#xD;
      therapeutic approach in significantly congested subjects with Acute Decompensated Heart&#xD;
      Failure (ADHF), who are not diuresing adequately.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 31, 2019</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Freedom from Major Adverse Events through 90 days post-discharge.</measure>
    <time_frame>90 days post-discharge</time_frame>
    <description>MAE is defined as death, myocardial infarction, major thromboembolic event, vascular damage requiring surgical intervention, hemorrhagic stroke or prolongation of heart failure- related hospitalization attributable to the preCARDIA device or procedure.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Acute Decompensated Heart Failure</condition>
  <condition>Acute Heart Failure</condition>
  <condition>Congestive Heart Failure</condition>
  <condition>Heart Diseases</condition>
  <arm_group>
    <arm_group_label>ADHF Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with preCARDIA System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>preCARDIA system</intervention_name>
    <description>Intermittent occlusion of the SVC</description>
    <arm_group_label>ADHF Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  NYHA Class III-IV heart failure&#xD;
&#xD;
          -  Subjects with inadequate diuresis&#xD;
&#xD;
          -  Stage C-D systolic heart failure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active myocardial ischemia or acute coronary syndrome (ACS)&#xD;
&#xD;
          -  Severe aortic or mitral valve insufficiency&#xD;
&#xD;
          -  Severe peripheral vascular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Kelsey Hedquist</last_name>
    <phone>651-252-1773</phone>
    <email>venushf@abiomed.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Northwestern</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Kansas University Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Precardia</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CentraCare Heart &amp; Vascular Center</name>
      <address>
        <city>Saint Cloud</city>
        <state>Minnesota</state>
        <zip>56303</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Providence Health &amp; Services</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Precardia</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Allegheny General Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>preCardia</last_name>
    </contact>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Precardia</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Houston Methodist</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Precardia</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>July 26, 2023</last_update_submitted>
  <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Heart Diseases</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/NCT03836079
org study id: 101773-002
nct id: NCT03836079
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
Safety and performance evaluation of the preCARDIA System for patients with ADHF.
The objective of this early feasibility study is to evaluate the safety and performance of
      the preCARDIA System for Superior Vena Caval (SVC) intermittent mechanical occlusion as a
      therapeutic approach in significantly congested subjects with Acute Decompensated Heart
      Failure (ADHF), who are not diuresing adequately.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Freedom from Major Adverse Events through 90 days post-discharge.
time frame: 90 days post-discharge
description: MAE is defined as death, myocardial infarction, major thromboembolic event, vascular damage requiring surgical intervention, hemorrhagic stroke or prolongation of heart failure- related hospitalization attributable to the preCARDIA device or procedure.
arm group label: ADHF Patients
arm group type: Experimental
description: Treatment with preCARDIA System
intervention type: Device
intervention name: preCARDIA system
description: Intermittent occlusion of the SVC
arm group label: ADHF Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Kelsey Hedquist
phone: 651-252-1773
email: venushf@abiomed.com
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Heart Diseases