<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/NCT03251742</url>
  </required_header>
  <id_info>
    <org_study_id>Fontan0615</org_study_id>
    <nct_id>NCT03251742</nct_id>
  </id_info>
  <brief_title>Feasibility and Efficacy of Portable Non-invasive Negative Pressure Ventilation in Fontan Patients</brief_title>
  <acronym>FONTAN-CMR</acronym>
  <official_title>Feasibility and Efficacy Of Negative Pressure Ventilation in Fontan populatioN: Cardiovascular Flow Assessment by Magnetic Resonance Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hayek Medical</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Health Network, Toronto</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>
      The human heart has 4 chambers: 2 collecting chambers (atria) and 2 pumping chambers&#xD;
      (ventricles) to allow blood flow within two distinct circuits: &quot;pulmonary&quot; and &quot;systemic&quot;.&#xD;
      The pulmonary circuit directs the blood to the lungs to receive oxygen and the systemic&#xD;
      circuit delivers oxygen-rich blood throughout the body. In children born with a single&#xD;
      ventricle, blood from these two circuits mixes within the heart resulting in lower oxygen&#xD;
      levels in the blood delivered to the body (cyanosis).&#xD;
&#xD;
      The Fontan procedure is a palliative surgery which bypasses the need for a ventricle to&#xD;
      deliver blood to the lungs, as blood from the body flows passively to the lungs by a man-made&#xD;
      connection (whereby two large body veins [cavae] are sewn to the pulmonary arteries), thereby&#xD;
      preventing mixing of blood through restoration of two distinct circuits without mixing of&#xD;
      blood. Although the Fontan operation effectively eliminates cyanosis and enables survival&#xD;
      into adulthood, increased systemic venous pressure is an unavoidable systemic complication&#xD;
      and low cardiac output (CO) is pervasive finding.&#xD;
&#xD;
      Despite excellent pediatric surgical results, the risk of late complications and death&#xD;
      dramatically increases in the decades following Fontan surgery. A chronically low CO state&#xD;
      secondary to decreased forward flow of blood to the lungs can result in end-organ dysfunction&#xD;
      and shortened life expectancy. Short of heart transplantation, deemed suitable only for a&#xD;
      minority of patients, effective therapies for low CO are largely absent. The investigators&#xD;
      aim to investigate a novel, non-invasive, ambulatory therapy which can augment CO.&#xD;
      Specifically, external suction is applied intermittently to the chest wall, much like a&#xD;
      vacuum, to increase CO, called negative pressure ventilation (NPV) using a Cuirass®&#xD;
      ventilator (Hayek Medical). Although used in patients with lung disease, the investigators'&#xD;
      proposal is to evaluate this novel, portable, ventilation system would be the first study of&#xD;
      its kind in adults with congenital heart disease, specifically those with a Fontan&#xD;
      palliation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 17, 2017</start_date>
  <completion_date type="Actual">May 1, 2018</completion_date>
  <primary_completion_date type="Actual">May 1, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a cross-sectional study designed to evaluate the immediate impact of negative pressure ventilation (NPV) in an ambulatory Fontan population using cardiovascular magnetic resonance imaging (CMR) for assessment of cardiovascular flows.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of the NPV on cardiac output</measure>
    <time_frame>6-8 months</time_frame>
    <description>Cardiac output will be measured in L/min/m2 using phase contrast MRI. Flow measurements will be made at baseline and with application of the device.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of the NPV on organ perfusion</measure>
    <time_frame>6-8 months</time_frame>
    <description>Multi organ perfusion will be measured in L/min/m2 using phase contrast MRI. Flow measurements will be made at baseline and with application of the device.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tolerability and safety of negative pressure ventilation.</measure>
    <time_frame>6-8 months</time_frame>
    <description>Assessed by participant questionnaire rating tolerance, safety, overall satisfaction with the device.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Fontan Physiology</condition>
  <arm_group>
    <arm_group_label>Fontan patient population</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hayek RTX ventilator</intervention_name>
    <description>Negative pressure ventilation in Fontan patients.</description>
    <arm_group_label>Fontan patient population</arm_group_label>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <other_name>Cuirass</other_name>
    <other_name>Negative pressure ventilation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fontan patients age &gt; 13 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to complete MRI (pacemaker/defibrillator/retained wires, pregnancy,&#xD;
             claustrophobia);&#xD;
&#xD;
          -  evidence of Fontan failure (requiring ongoing medical / device therapy) protein-losing&#xD;
             enteropathy, intracardiac thrombus, anatomical obstruction to the Fontan circuit;&#xD;
&#xD;
          -  patent Fontan fenestration;&#xD;
&#xD;
          -  oxygen saturation &lt; 90%;&#xD;
&#xD;
          -  ongoing arrhythmia;&#xD;
&#xD;
          -  ejection fraction &lt; 50% on echocardiography or CMR;&#xD;
&#xD;
          -  moderate or severe valve insufficiency on echocardiography or CMR;&#xD;
&#xD;
          -  Obesity (BMI &gt;35);&#xD;
&#xD;
          -  severe obstructive sleep apnea (AHI&gt;20);&#xD;
&#xD;
          -  chronic obstructive lung disease (FEV1/FVC&lt;60%);&#xD;
&#xD;
          -  severe chest wall deformities (scoliosis, kyphosis, kyphoscoliosis);&#xD;
&#xD;
          -  acute or chronic kidney disease (eGFR&lt;60)&#xD;
&#xD;
          -  unable to provide informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachel Wald, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Toronto General Hospital/University Health Network</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pradeepkumar Charla, MD, MS</last_name>
    <role>Study Director</role>
    <affiliation>Toronto General Hospital/University Health Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Toronto General Hospital/University of Toronto.</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G2N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>April 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>May 30, 2018</last_update_submitted>
  <last_update_submitted_qc>May 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Health Network, Toronto</investigator_affiliation>
    <investigator_full_name>Pradeepkumar Charla</investigator_full_name>
    <investigator_title>Clinical Fellow</investigator_title>
  </responsible_party>
  <keyword>Fontan operation</keyword>
  <keyword>Negative pressure ventilation</keyword>
  <keyword>MRI</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03251742
org study id: Fontan0615
nct id: NCT03251742
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The human heart has 4 chambers: 2 collecting chambers (atria) and 2 pumping chambers
      (ventricles) to allow blood flow within two distinct circuits: "pulmonary" and "systemic".
      The pulmonary circuit directs the blood to the lungs to receive oxygen and the systemic
      circuit delivers oxygen-rich blood throughout the body. In children born with a single
      ventricle, blood from these two circuits mixes within the heart resulting in lower oxygen
      levels in the blood delivered to the body (cyanosis).

      The Fontan procedure is a palliative surgery which bypasses the need for a ventricle to
      deliver blood to the lungs, as blood from the body flows passively to the lungs by a man-made
      connection (whereby two large body veins [cavae] are sewn to the pulmonary arteries), thereby
      preventing mixing of blood through restoration of two distinct circuits without mixing of
      blood. Although the Fontan operation effectively eliminates cyanosis and enables survival
      into adulthood, increased systemic venous pressure is an unavoidable systemic complication
      and low cardiac output (CO) is pervasive finding.

      Despite excellent pediatric surgical results, the risk of late complications and death
      dramatically increases in the decades following Fontan surgery. A chronically low CO state
      secondary to decreased forward flow of blood to the lungs can result in end-organ dysfunction
      and shortened life expectancy. Short of heart transplantation, deemed suitable only for a
      minority of patients, effective therapies for low CO are largely absent. The investigators
      aim to investigate a novel, non-invasive, ambulatory therapy which can augment CO.
      Specifically, external suction is applied intermittently to the chest wall, much like a
      vacuum, to increase CO, called negative pressure ventilation (NPV) using a Cuirass®
      ventilator (Hayek Medical). Although used in patients with lung disease, the investigators'
      proposal is to evaluate this novel, portable, ventilation system would be the first study of
      its kind in adults with congenital heart disease, specifically those with a Fontan
      palliation.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: This is a cross-sectional study designed to evaluate the immediate impact of negative pressure ventilation (NPV) in an ambulatory Fontan population using cardiovascular magnetic resonance imaging (CMR) for assessment of cardiovascular flows.
primary purpose: Other
masking: None (Open Label)
measure: Efficacy of the NPV on cardiac output
time frame: 6-8 months
description: Cardiac output will be measured in L/min/m2 using phase contrast MRI. Flow measurements will be made at baseline and with application of the device.
measure: Efficacy of the NPV on organ perfusion
time frame: 6-8 months
description: Multi organ perfusion will be measured in L/min/m2 using phase contrast MRI. Flow measurements will be made at baseline and with application of the device.
measure: Tolerability and safety of negative pressure ventilation.
time frame: 6-8 months
description: Assessed by participant questionnaire rating tolerance, safety, overall satisfaction with the device.
arm group label: Fontan patient population
arm group type: Active Comparator
arm group label: Healthy volunteers
arm group type: Sham Comparator
intervention type: Device
intervention name: Hayek RTX ventilator
description: Negative pressure ventilation in Fontan patients.
arm group label: Fontan patient population
arm group label: Healthy volunteers
other name: Cuirass
other name: Negative pressure ventilation
criteria: 
gender: All
minimum age: 13 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rachel Wald, MD, MS
role: Principal Investigator
affiliation: Toronto General Hospital/University Health Network
last name: Pradeepkumar Charla, MD, MS
role: Study Director
affiliation: Toronto General Hospital/University Health Network
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University Health Network, Toronto
investigator full name: Pradeepkumar Charla
investigator title: Clinical Fellow
sharing ipd: No