<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/NCT03751748</url>
  </required_header>
  <id_info>
    <org_study_id>AC201809</org_study_id>
    <nct_id>NCT03751748</nct_id>
  </id_info>
  <brief_title>Flow Regulation by Opening the Septum in Patients With Heart Failure Trial</brief_title>
  <acronym>FROST-HF</acronym>
  <official_title>Flow Regulation by Opening the Septum in Patients With Heart Failure (FROST-HF) Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sinai Health System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Unity Health Toronto</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To investigate the safety and efficacy of a novel atrial flow regulator (AFR) device in&#xD;
      patients with heart failure and preserved ejection fraction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will allow us to demonstrate the safety of the AFR device as well as determine the&#xD;
      clinical response of the therapeutic intervention. In addition, the invasive exercise&#xD;
      hemodynamics will provide objective data for the changes in the cardiac hemodynamics and&#xD;
      delineate underlying mechanisms of creating a permanent inter atrial shunting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">April 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Multicenter, randomized, sham controlled, single blind with objective end points.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6MWT</measure>
    <time_frame>12 months</time_frame>
    <description>Six minute walk test at 12 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MACE</measure>
    <time_frame>12 months</time_frame>
    <description>Composite of cardiac death, heart failure hospitalization and worsening heart failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac death</measure>
    <time_frame>12 months</time_frame>
    <description>Death from a cardiac cause (myocardial infarction, sudden death)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Congestive heart failure (CHF)</measure>
    <time_frame>12 months</time_frame>
    <description>Heart failure hospitalization, worsening heart failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QOL)</measure>
    <time_frame>12 months</time_frame>
    <description>QOL as per KCCQE questionaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">230</enrollment>
  <condition>Heart Failure With Normal Ejection Fraction</condition>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AFR arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implantation of Occlutech atrial flow regulator (AFR) device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AFR implantation</intervention_name>
    <description>Implantation of atrial flow regulator (AFR) device</description>
    <arm_group_label>AFR arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham procedure</intervention_name>
    <description>Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo</description>
    <arm_group_label>Control arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Age &gt; 40 years&#xD;
&#xD;
          -  LVEF &gt; 45% documented within the last 3 months.&#xD;
&#xD;
          -  NYHA class ≥II status or 6MWT distance &lt;80% predicted.&#xD;
&#xD;
          -  Left atrial enlargement&#xD;
&#xD;
          -  PCWP ≥25 mmHg during supine bicycle exercise on hemodynamic monitoring.&#xD;
&#xD;
          -  Left atrial pressure greater than right atrial pressure by ≥5 mmHg on hemodynamic&#xD;
             monitoring.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent MI, PCI or CABG&#xD;
&#xD;
          -  Untreated CAD with indication for revascularization&#xD;
&#xD;
          -  Recent stroke, pulmonary embolism or major surgery&#xD;
&#xD;
          -  Uncontrolled atrial fibrillation&#xD;
&#xD;
          -  H/O cardiomyopathy (hypertrophic, restrictive, infiltrative) or pericardial disease&#xD;
&#xD;
          -  Inability to perform a 6-minute walk test.&#xD;
&#xD;
          -  Clinically significant valvular disease&#xD;
&#xD;
          -  Uunsuitable for study participation at investigator discretion.&#xD;
&#xD;
          -  Severe COPD, Anemia or morbid obesity&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Women of child bearing age&#xD;
&#xD;
          -  RA pressure &gt;15 mmHg or PVR &gt;4 wood units&#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_contact>
    <last_name>Asim Cheema, MD, PhD</last_name>
    <phone>416-864-5739</phone>
    <email>cheemaa@smh.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>St. Michael's hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <contact>
      <last_name>Asim Cheema, MD</last_name>
      <phone>416-864-5739</phone>
      <email>cheemaA@smh.ca</email>
    </contact>
    <investigator>
      <last_name>Asim Cheema, MD, FRCPC</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Abdul Alhesayen, MD, FRCPC</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sinai Health System</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <contact>
      <last_name>Susanna Mak, MD, FRCPC</last_name>
    </contact>
    <investigator>
      <last_name>Susanna Mak, MD, FRCPC</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <contact>
      <last_name>Mark Osten, MD, FRCPC</last_name>
    </contact>
    <investigator>
      <last_name>Mark Osten, MD, FRCPC</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 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>Heart Failure</mesh_term>
  </condition_browse>
  <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/NCT03751748
org study id: AC201809
nct id: NCT03751748
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To investigate the safety and efficacy of a novel atrial flow regulator (AFR) device in
      patients with heart failure and preserved ejection fraction.
The study will allow us to demonstrate the safety of the AFR device as well as determine the
      clinical response of the therapeutic intervention. In addition, the invasive exercise
      hemodynamics will provide objective data for the changes in the cardiac hemodynamics and
      delineate underlying mechanisms of creating a permanent inter atrial shunting.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Multicenter, randomized, sham controlled, single blind with objective end points.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: 6MWT
time frame: 12 months
description: Six minute walk test at 12 months
measure: MACE
time frame: 12 months
description: Composite of cardiac death, heart failure hospitalization and worsening heart failure
measure: Cardiac death
time frame: 12 months
description: Death from a cardiac cause (myocardial infarction, sudden death)
measure: Congestive heart failure (CHF)
time frame: 12 months
description: Heart failure hospitalization, worsening heart failure
measure: Quality of Life (QOL)
time frame: 12 months
description: QOL as per KCCQE questionaire
arm group label: Control arm
arm group type: Sham Comparator
description: Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo
arm group label: AFR arm
arm group type: Experimental
description: Implantation of Occlutech atrial flow regulator (AFR) device
intervention type: Device
intervention name: AFR implantation
description: Implantation of atrial flow regulator (AFR) device
arm group label: AFR arm
intervention type: Device
intervention name: Sham procedure
description: Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo
arm group label: Control arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Asim Cheema, MD, PhD
phone: 416-864-5739
email: cheemaa@smh.ca
facility: 
contact: 
investigator: 
investigator: 
facility: 
contact: 
investigator: 
facility: 
contact: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No