<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/NCT02984631</url>
  </required_header>
  <id_info>
    <org_study_id>CFT-37215-ECH-02</org_study_id>
    <nct_id>NCT02984631</nct_id>
  </id_info>
  <brief_title>The Evaluation and Treatment of Elevated Left-Sided Filling Pressures by Balloon Inflation Within the IVC</brief_title>
  <official_title>The Evaluation and Treatment of Elevated Left-Sided Filling Pressures by Balloon Inflation Within the Interior Vena Cava</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardioflow Technologies, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cardioflow Technologies, LLC</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>
      In patients with heart failure, elevated filling pressures may contribute to symptoms while&#xD;
      not improving cardiac output. The current study is focused on evaluating the relationship&#xD;
      between exercise capacity, pulmonary pressures, cardiopulmonary parameters, and symptoms of&#xD;
      dyspnea in patients with heart failure during exercise.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous studies have suggested that intracardiac pressures can be decreased without&#xD;
      compromising cardiac function. During an invasive cardiopulmonary exercise test (CPET),&#xD;
      catheters are placed within the heart and pulmonary vasculature to evaluate cardiopulmonary&#xD;
      function in response to exercise. We will be testing whether pulmonary hypertension can be&#xD;
      prevented during exercise by adjusting right ventricular pre-load. We will also be evaluating&#xD;
      parameters of cardiopulmonary function during the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in respiratory rate at matched levels of exercise.</measure>
    <time_frame>During the CPET, within 30 minutes of study.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in patient symptoms-- dyspnea and leg discomfort (Borg units)</measure>
    <time_frame>During the CPET, within 30 minutes of study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in ventilatory threshold</measure>
    <time_frame>During the CPET, within 30 minutes of study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in exercise time</measure>
    <time_frame>During the CPET, within 30 minutes of study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in heart rate for given level of exercise (work rate in watts)</measure>
    <time_frame>During the CPET, within 30 minutes of study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anaerobic threshold</measure>
    <time_frame>During the CPET, within 30 minutes of study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pulmonary diastolic pressure for a given level of exercise (work rate)</measure>
    <time_frame>During the CPET, within 30 minutes of study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in dead space ventilation at a given level of exercise (and VE/VCO2 slope)</measure>
    <time_frame>During the CPET, within 30 minutes of study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cardiac output at a given level of exercise</measure>
    <time_frame>During the CPET, within 30 minutes of study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determining predictors of peak VO2</measure>
    <time_frame>During the CPET, within 30 minutes of study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in oxygen uptake at a given level of exercise</measure>
    <time_frame>During the CPET, within 30 minutes of study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pH level at a given level of exercise</measure>
    <time_frame>During the CPET, within 30 minutes of study.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Peak VO2</measure>
    <time_frame>During the CPET, within 30 minutes of study.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Hypertension, Pulmonary</condition>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Preventing pulm HTN during exercise 2nd</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard of care invasive cardiopulmonary exercise test (CPET) followed by CPET with pre-load control.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Preventing pulm HTN during exercise 1st</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Pre-load control of invasive cardiopulmonary exercise test (CPET) followed by standard CPET.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Preventing pulm HTN during exercise</intervention_name>
    <description>Balloon catheter is inflated within the IVC to maintain pulmonary pressures during exercise.</description>
    <arm_group_label>Preventing pulm HTN during exercise 1st</arm_group_label>
    <arm_group_label>Preventing pulm HTN during exercise 2nd</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects scheduled to undergo an exercise right heart catheterization at El Camino&#xD;
             Hospital.&#xD;
&#xD;
          2. New York Heart Association (NYHA) II or III.&#xD;
&#xD;
          3. Subjects must be between 18 and 80 years of age.&#xD;
&#xD;
          4. A left ventricular ejection fraction ≥ 35%.&#xD;
&#xD;
          5. Subjective or objective evidence (e.g. 6 minute walk test) of impaired exercise&#xD;
             capacity.&#xD;
&#xD;
          6. Is willing and able to sign an IRB-approved written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to peddle exercise while laying flat.&#xD;
&#xD;
          2. More than mild valve disease.&#xD;
&#xD;
          3. Clinical or objective evidence of inducible myocardial ischemia.&#xD;
&#xD;
          4. Significant lung disease, such as prior diagnosis of COPD.&#xD;
&#xD;
          5. Resting or dynamic outflow tract gradient.&#xD;
&#xD;
          6. Severe pulmonary HTN (&gt;60mmHg at rest)&#xD;
&#xD;
          7. Moderate to severe RV dysfunction&#xD;
&#xD;
          8. History of DVT, PE&#xD;
&#xD;
          9. Pregnancy (women of child-bearing age, regardless of contraceptive measures, must be&#xD;
             willing to take a pregnancy test prior to the study).&#xD;
&#xD;
         10. Recent major surgery or hospitalization (within 30 days)&#xD;
&#xD;
         11. Participation in another clinical study (within 30 days)&#xD;
&#xD;
         12. Advanced neurological disease (e.g. dementia)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel W Kaiser, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Electrophysiologist at El Camino Hospital.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniel W Kaiser, MD</last_name>
    <email>danielkaisermd@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>El Camino Hospital</name>
      <address>
        <city>Mountain View</city>
        <state>California</state>
        <zip>94040</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ryan Schroeder</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>December 3, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>April 5, 2018</last_update_submitted>
  <last_update_submitted_qc>April 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2018</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>Hypertension, Pulmonary</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02984631
org study id: CFT-37215-ECH-02
nct id: NCT02984631
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In patients with heart failure, elevated filling pressures may contribute to symptoms while
      not improving cardiac output. The current study is focused on evaluating the relationship
      between exercise capacity, pulmonary pressures, cardiopulmonary parameters, and symptoms of
      dyspnea in patients with heart failure during exercise.
Previous studies have suggested that intracardiac pressures can be decreased without
      compromising cardiac function. During an invasive cardiopulmonary exercise test (CPET),
      catheters are placed within the heart and pulmonary vasculature to evaluate cardiopulmonary
      function in response to exercise. We will be testing whether pulmonary hypertension can be
      prevented during exercise by adjusting right ventricular pre-load. We will also be evaluating
      parameters of cardiopulmonary function during the study.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Reduction in respiratory rate at matched levels of exercise.
time frame: During the CPET, within 30 minutes of study.
measure: Change in patient symptoms-- dyspnea and leg discomfort (Borg units)
time frame: During the CPET, within 30 minutes of study.
measure: Change in ventilatory threshold
time frame: During the CPET, within 30 minutes of study.
measure: Change in exercise time
time frame: During the CPET, within 30 minutes of study.
measure: Change in heart rate for given level of exercise (work rate in watts)
time frame: During the CPET, within 30 minutes of study.
measure: Change in anaerobic threshold
time frame: During the CPET, within 30 minutes of study.
measure: Change in pulmonary diastolic pressure for a given level of exercise (work rate)
time frame: During the CPET, within 30 minutes of study.
measure: Change in dead space ventilation at a given level of exercise (and VE/VCO2 slope)
time frame: During the CPET, within 30 minutes of study.
measure: Change in cardiac output at a given level of exercise
time frame: During the CPET, within 30 minutes of study.
measure: Determining predictors of peak VO2
time frame: During the CPET, within 30 minutes of study.
measure: Change in oxygen uptake at a given level of exercise
time frame: During the CPET, within 30 minutes of study.
measure: Change in pH level at a given level of exercise
time frame: During the CPET, within 30 minutes of study.
measure: Change in Peak VO2
time frame: During the CPET, within 30 minutes of study.
arm group label: Preventing pulm HTN during exercise 2nd
arm group type: Other
description: Standard of care invasive cardiopulmonary exercise test (CPET) followed by CPET with pre-load control.
arm group label: Preventing pulm HTN during exercise 1st
arm group type: Other
description: Pre-load control of invasive cardiopulmonary exercise test (CPET) followed by standard CPET.
intervention type: Procedure
intervention name: Preventing pulm HTN during exercise
description: Balloon catheter is inflated within the IVC to maintain pulmonary pressures during exercise.
arm group label: Preventing pulm HTN during exercise 1st
arm group label: Preventing pulm HTN during exercise 2nd
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Daniel W Kaiser, MD
role: Principal Investigator
affiliation: Electrophysiologist at El Camino Hospital.
last name: Daniel W Kaiser, MD
email: danielkaisermd@gmail.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Hypertension, Pulmonary
sharing ipd: Undecided