<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/NCT04405583</url>
  </required_header>
  <id_info>
    <org_study_id>Occ2020_01</org_study_id>
    <nct_id>NCT04405583</nct_id>
  </id_info>
  <brief_title>The AFteR Registry - Follow-up Study to Monitor the Efficacy and Safety of the Occlutech AFR in Heart Failure Patients</brief_title>
  <official_title>A Multicentre, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech Atrial Flow Regulator in Heart Failure Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Occlutech International AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Occlutech International AB</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 study aims to monitor the safety and effectiveness of the Occlutech AFR device in&#xD;
      patients with heart failure for 3 years following AFR device implantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, multicentre, international, follow-up registry to monitor the safety and the&#xD;
      performance of the Occlutech AFR device in patients with Heart Failure, evaluated by vital&#xD;
      signs, laboratory tests, quality of life questionnaire, ECG, and echocardiography data.&#xD;
      Patients will be treated according to the instruction-for-use of the device and according to&#xD;
      clinical routine by experienced physicians.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 28, 2020</start_date>
  <completion_date type="Anticipated">October 2027</completion_date>
  <primary_completion_date type="Anticipated">October 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Safety in the 1 year following implantation</measure>
    <time_frame>1 year</time_frame>
    <description>Percentage of patients with at least one SADE</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Device Placement</measure>
    <time_frame>3 years</time_frame>
    <description>Device in situ in the 3 years following implantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left-Right shunt through AFR device</measure>
    <time_frame>3 years</time_frame>
    <description>Evidence of left to right shunt through the AFR device in the 3 years following implantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NYHA status</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of life</measure>
    <time_frame>3 years</time_frame>
    <description>Change in quality of life as assessed by KCCQ</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Heart Failure</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Occlutech Atrial Flow Regulator</intervention_name>
    <description>The Occlutech Atrial Flow Regulator is an interatrial shunt device for transcatheter delivery.</description>
    <other_name>Occlutech AFR</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study will enroll 100 Patients with Heart Failure over 18 years of age, for whom AFR&#xD;
        Implantation is indicated and planned.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients for whom Occlutech AFR Implantation is indicated and planned&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Written informed consent is available&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any condition that, in the opinion of the investigator might interfere with the&#xD;
             implantation of affect the patients well-being&#xD;
&#xD;
          -  Sepsis (local or generalized) or acute infections&#xD;
&#xD;
          -  Allergy to anti-platelet, anti-coagulant or ani-thrombotic therapy&#xD;
&#xD;
          -  Allergy to nickel and/or Titanium and or nickel-titanium-based matierials&#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>Gonul Sonmez Utkun</last_name>
    <phone>+90 542 826 11 95</phone>
    <email>dl_occlutech_clinical_team_eu-ist@occlutech.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Inga-Maria Wefel</last_name>
    <phone>+49 171 715 85 88</phone>
    <email>dl_occlutech_clinical_team_eu-ist@occlutech.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHU Besançon</name>
      <address>
        <city>Besançon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU Lyon</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinic Coburg</name>
      <address>
        <city>Coburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Clinic</name>
      <address>
        <city>Cologne</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Helios Clinic Erfurt</name>
      <address>
        <city>Erfurt</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cardiologicum Hamburg</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>WKK Heide</name>
      <address>
        <city>Heide</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Clinic Jena</name>
      <address>
        <city>Jena</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinic Osnabrück</name>
      <address>
        <city>Osnabrück</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Osnabrueck</name>
      <address>
        <city>Osnabrück</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Elbe Clinic Stade</name>
      <address>
        <city>Stade</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Clinic Tübingen</name>
      <address>
        <city>Tübingen</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>June 14, 2023</last_update_submitted>
  <last_update_submitted_qc>June 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</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/NCT04405583
org study id: Occ2020_01
nct id: NCT04405583
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to monitor the safety and effectiveness of the Occlutech AFR device in
      patients with heart failure for 3 years following AFR device implantation.
Prospective, multicentre, international, follow-up registry to monitor the safety and the
      performance of the Occlutech AFR device in patients with Heart Failure, evaluated by vital
      signs, laboratory tests, quality of life questionnaire, ECG, and echocardiography data.
      Patients will be treated according to the instruction-for-use of the device and according to
      clinical routine by experienced physicians.
observational model: Case-Only
time perspective: Prospective
measure: Safety in the 1 year following implantation
time frame: 1 year
description: Percentage of patients with at least one SADE
measure: Device Placement
time frame: 3 years
description: Device in situ in the 3 years following implantation
measure: Left-Right shunt through AFR device
time frame: 3 years
description: Evidence of left to right shunt through the AFR device in the 3 years following implantation
measure: NYHA status
time frame: 3 years
measure: Change in Quality of life
time frame: 3 years
description: Change in quality of life as assessed by KCCQ
intervention type: Device
intervention name: Occlutech Atrial Flow Regulator
description: The Occlutech Atrial Flow Regulator is an interatrial shunt device for transcatheter delivery.
other name: Occlutech AFR
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gonul Sonmez Utkun
phone: +90 542 826 11 95
email: dl_occlutech_clinical_team_eu-ist@occlutech.com
last name: Inga-Maria Wefel
phone: +49 171 715 85 88
email: dl_occlutech_clinical_team_eu-ist@occlutech.com
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
country: France
country: Germany
responsible party type: Sponsor
mesh term: Heart Failure