<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/NCT03234647</url>
  </required_header>
  <id_info>
    <org_study_id>Doraya FIH Study for AHF</org_study_id>
    <nct_id>NCT03234647</nct_id>
  </id_info>
  <brief_title>First In Human Study of the Doraya Catheter for the Treatment of AHF Patients</brief_title>
  <official_title>First In Human Study of the Doraya Catheter for the Treatment of AHF Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Revamp Medical Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Revamp Medical Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Safety and performance evaluation of the Doraya catheter in patients admitted with AHF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this clinical investigation is to evaluate the safety and performance of the&#xD;
      Doraya catheter in patients admitted with AHF, presenting persistent volume over load and&#xD;
      poor response to diuretic treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Device or procedure related Serious Adverse Event (SAE) rate through 60 days</measure>
    <time_frame>60 days</time_frame>
    <description>SAE as defined by ISO 14155</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Acute Heart Failure</condition>
  <arm_group>
    <arm_group_label>AHF patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AHF patient treatment with the Doraya catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Doraya catheter</intervention_name>
    <description>Temporary deployment of the Doraya catheter in AHF patients.</description>
    <arm_group_label>AHF patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AHF subjects with poor diuretic response&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  AHF subjects with sufficient diuretic response&#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_official>
    <last_name>Tal Hasin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shaare Zedek Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Onze-Lieve-Vrouwziekenhuis Aalst</name>
      <address>
        <city>Aalst</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ZNA Middelheim</name>
      <address>
        <city>Antwerpen</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Śląski Uniwersytet Medyczny w Katowicach</name>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>4th Military</name>
      <address>
        <city>Wrocław</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Wrocław</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Israel</country>
    <country>Poland</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>May 4, 2021</last_update_submitted>
  <last_update_submitted_qc>May 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2021</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>
  <!-- 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/NCT03234647
org study id: Doraya FIH Study for AHF
nct id: NCT03234647
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Safety and performance evaluation of the Doraya catheter in patients admitted with AHF.
The purpose of this clinical investigation is to evaluate the safety and performance of the
      Doraya catheter in patients admitted with AHF, presenting persistent volume over load and
      poor response to diuretic treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Device or procedure related Serious Adverse Event (SAE) rate through 60 days
time frame: 60 days
description: SAE as defined by ISO 14155
arm group label: AHF patients
arm group type: Experimental
description: AHF patient treatment with the Doraya catheter
intervention type: Device
intervention name: Doraya catheter
description: Temporary deployment of the Doraya catheter in AHF patients.
arm group label: AHF patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Tal Hasin, MD
role: Principal Investigator
affiliation: Shaare Zedek Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Israel
country: Poland
responsible party type: Sponsor
mesh term: Heart Failure