<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/NCT03247829</url>
  </required_header>
  <id_info>
    <org_study_id>SJM-CIP-10178</org_study_id>
    <nct_id>NCT03247829</nct_id>
  </id_info>
  <brief_title>Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™</brief_title>
  <acronym>Intellect2</acronym>
  <official_title>Investigation to Optimize Hemodynamic Management of HeartMate II™ Left Ventricular Assist Device Patients Using the CardioMEMS™ Pulmonary Artery Pressure Sensor in Advanced Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This observational post market study is intended to characterize hemodynamic-guided&#xD;
      management of patients with an existing left ventricular assist device (LVAD) to protocol&#xD;
      specified target ranges and its impact on functional status, quality of life, and&#xD;
      readmissions&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is an observational, single group study where all participants receive the same&#xD;
      intervention. The study plans to enroll up to 100 patients at 25 US sites. All patients will&#xD;
      have a HeartMate Left Ventricular Assist Device (LVAD) and a CardioMEMS device implanted as&#xD;
      standard of care. After enrollment into the study, the patient will be followed until six&#xD;
      month follow up completion. The objective of this clinical investigation is to understand the&#xD;
      role of hemodynamic monitoring in LVAD patients and:&#xD;
&#xD;
        -  Characterize PA pressure measurements with the CardioMEMS HF System in LVAD patients&#xD;
           under different clinical and physiologic conditions&#xD;
&#xD;
        -  Characterize the effects of PA pressure on functional status, quality of life, and&#xD;
           hospital readmissions of LVAD patients&#xD;
&#xD;
        -  Evaluate target ranges for PA pressure and assess the impact of medication and pump&#xD;
           speed changes on PA pressures&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 17, 2017</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 12, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Six Minute Hall Walk (6MHW) distance</measure>
    <time_frame>six months</time_frame>
    <description>Change in 6MHW distance</description>
  </primary_outcome>
  <other_outcome>
    <measure>CardioMEMS PA pressure over time</measure>
    <time_frame>six months</time_frame>
    <description>Changes in PA pressure measurement over time</description>
  </other_outcome>
  <other_outcome>
    <measure>Days PA pressure is in the pre-specified target range</measure>
    <time_frame>six months</time_frame>
    <description>Percentage of days PA pressure is in the pre-specified target range</description>
  </other_outcome>
  <other_outcome>
    <measure>PA pressure before 6MHW test to after 6MHW test</measure>
    <time_frame>six months</time_frame>
    <description>Changes in PA pressure before 6MHW test to after 6MHW test</description>
  </other_outcome>
  <other_outcome>
    <measure>CardioMEMS and HeartMate Device malfunctions</measure>
    <time_frame>six months</time_frame>
    <description>Loss of performance, such as inability to submit pressure data for CardioMEMS and/or Pump failure for LVAD</description>
  </other_outcome>
  <other_outcome>
    <measure>New York Heart Association (NYHA) classification</measure>
    <time_frame>six months</time_frame>
    <description>NYHA classification at baseline and each scheduled follow-up visit</description>
  </other_outcome>
  <other_outcome>
    <measure>EQ-5D-5L</measure>
    <time_frame>six months</time_frame>
    <description>Health related quality of life (EQ-5D-5L)</description>
  </other_outcome>
  <other_outcome>
    <measure>All-cause hospitalizations</measure>
    <time_frame>six months</time_frame>
    <description>All-cause hospitalization rate</description>
  </other_outcome>
  <other_outcome>
    <measure>Worsening heart failure events</measure>
    <time_frame>six months</time_frame>
    <description>Heart failure hospitalization rate including emergency department visits, or unscheduled clinic visits for worsening HF, volume management, and/or cardiovascular medication management</description>
  </other_outcome>
  <other_outcome>
    <measure>6MHW distance by PA pressure ranges</measure>
    <time_frame>six months</time_frame>
    <description>Change in 6MHW distance by various PA pressure ranges</description>
  </other_outcome>
  <other_outcome>
    <measure>NYHA class by PA pressure ranges</measure>
    <time_frame>six months</time_frame>
    <description>Change in NYHA class by various PA pressure ranges</description>
  </other_outcome>
  <other_outcome>
    <measure>EQ-5D-5L by PA pressure ranges</measure>
    <time_frame>six months</time_frame>
    <description>Change in EQ-5D-5L by various PA pressure ranges</description>
  </other_outcome>
  <other_outcome>
    <measure>All cause hospitalization rate by PA pressure ranges</measure>
    <time_frame>six months</time_frame>
    <description>All cause hospitalization rate by various PA pressure ranges</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">101</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Patients with CardioMEMS and LVAD</arm_group_label>
    <description>Patients with CardioMEMS and LVAD, previously implanted, will receive hemodynamic management using CardioMEMS</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hemodynamic management using CardioMEMS</intervention_name>
    <description>Using the CardioMEMS HF system, clinicians will treat to target PA pressure ranges</description>
    <arm_group_label>Patients with CardioMEMS and LVAD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Heart Failure patients will be recruited from the clinicians practice based on the presence&#xD;
        of both devices under study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject has CardioMEMS HF PA Sensor and a commercially-approved HeartMate LVAD (Group&#xD;
             A) OR Subject has commercially-approved HeartMate LVAD, is experiencing NYHA class III&#xD;
             symptoms, and has had a previous HF hospitalization and meets FDA indications for&#xD;
             CardioMEMS. The CardioMEMS sensor must be implanted within 72 hours of consent (Group&#xD;
             B)&#xD;
&#xD;
          2. Signed an informed consent form and agreed to provide access to patient and device&#xD;
             data (including CardioMEMS Merlin.net data)&#xD;
&#xD;
          3. No connectivity or transmission problems with CardioMEMS&#xD;
&#xD;
          4. On HeartMate LVAD support for at least 3 months&#xD;
&#xD;
          5. Age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current participation in an investigation that is likely to confound study results or&#xD;
             affect study outcome&#xD;
&#xD;
          2. Current participation in the MOMENTUM3 IDE Clinical trial and has not completed the&#xD;
             two year follow-up for that trial&#xD;
&#xD;
          3. Inability to perform 6MHW test due to conditions other than heart failure (e.g. severe&#xD;
             arthritis, orthopedic issues, amputation etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Poornima Sood</last_name>
    <role>Study Director</role>
    <affiliation>Abbott</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Scripps Health</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC University Hospital</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ronald Reagan UCLA Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Diego Cardiac</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 - Van Ness Campus</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</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>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore University Hospital</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York-Presbyterian/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>St. Francis Hospital</name>
      <address>
        <city>Roslyn</city>
        <state>New York</state>
        <zip>11576</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>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The 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 Sate University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Heart and Vascular Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palmetto Health Richland</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The 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 Utah Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora 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>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>January 7, 2021</last_update_submitted>
  <last_update_submitted_qc>January 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CardioMEMS</keyword>
  <keyword>Left Ventricular Assist Device</keyword>
  <keyword>Hemodynamic Management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>February 28, 2022</submitted>
    <returned>May 16, 2022</returned>
    <submitted>June 17, 2022</submitted>
    <returned>March 29, 2023</returned>
  </pending_results>
  <!-- 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/NCT03247829
org study id: SJM-CIP-10178
nct id: NCT03247829
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This observational post market study is intended to characterize hemodynamic-guided
      management of patients with an existing left ventricular assist device (LVAD) to protocol
      specified target ranges and its impact on functional status, quality of life, and
      readmissions
The study is an observational, single group study where all participants receive the same
      intervention. The study plans to enroll up to 100 patients at 25 US sites. All patients will
      have a HeartMate Left Ventricular Assist Device (LVAD) and a CardioMEMS device implanted as
      standard of care. After enrollment into the study, the patient will be followed until six
      month follow up completion. The objective of this clinical investigation is to understand the
      role of hemodynamic monitoring in LVAD patients and:

        -  Characterize PA pressure measurements with the CardioMEMS HF System in LVAD patients
           under different clinical and physiologic conditions

        -  Characterize the effects of PA pressure on functional status, quality of life, and
           hospital readmissions of LVAD patients

        -  Evaluate target ranges for PA pressure and assess the impact of medication and pump
           speed changes on PA pressures
observational model: Cohort
time perspective: Prospective
measure: Six Minute Hall Walk (6MHW) distance
time frame: six months
description: Change in 6MHW distance
measure: CardioMEMS PA pressure over time
time frame: six months
description: Changes in PA pressure measurement over time
measure: Days PA pressure is in the pre-specified target range
time frame: six months
description: Percentage of days PA pressure is in the pre-specified target range
measure: PA pressure before 6MHW test to after 6MHW test
time frame: six months
description: Changes in PA pressure before 6MHW test to after 6MHW test
measure: CardioMEMS and HeartMate Device malfunctions
time frame: six months
description: Loss of performance, such as inability to submit pressure data for CardioMEMS and/or Pump failure for LVAD
measure: New York Heart Association (NYHA) classification
time frame: six months
description: NYHA classification at baseline and each scheduled follow-up visit
measure: EQ-5D-5L
time frame: six months
description: Health related quality of life (EQ-5D-5L)
measure: All-cause hospitalizations
time frame: six months
description: All-cause hospitalization rate
measure: Worsening heart failure events
time frame: six months
description: Heart failure hospitalization rate including emergency department visits, or unscheduled clinic visits for worsening HF, volume management, and/or cardiovascular medication management
measure: 6MHW distance by PA pressure ranges
time frame: six months
description: Change in 6MHW distance by various PA pressure ranges
measure: NYHA class by PA pressure ranges
time frame: six months
description: Change in NYHA class by various PA pressure ranges
measure: EQ-5D-5L by PA pressure ranges
time frame: six months
description: Change in EQ-5D-5L by various PA pressure ranges
measure: All cause hospitalization rate by PA pressure ranges
time frame: six months
description: All cause hospitalization rate by various PA pressure ranges
arm group label: Patients with CardioMEMS and LVAD
description: Patients with CardioMEMS and LVAD, previously implanted, will receive hemodynamic management using CardioMEMS
intervention type: Device
intervention name: Hemodynamic management using CardioMEMS
description: Using the CardioMEMS HF system, clinicians will treat to target PA pressure ranges
arm group label: Patients with CardioMEMS and LVAD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Poornima Sood
role: Study Director
affiliation: Abbott
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country: United States
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No
submitted: February 28, 2022
returned: May 16, 2022
submitted: June 17, 2022
returned: March 29, 2023