<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/NCT03003481</url>
  </required_header>
  <id_info>
    <org_study_id>Occ2016_01</org_study_id>
    <nct_id>NCT03003481</nct_id>
  </id_info>
  <brief_title>Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech PLD Device</brief_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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Collect patient data and to monitor the clinical use (safety and efficacy) of the device&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">May 2021</completion_date>
  <primary_completion_date type="Actual">May 2021</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>4 Years</target_duration>
  <primary_outcome>
    <measure>Proper closure of the PVL (defined as Reduction in paravalvular regurgitation of ≥ one grade as assessed by echocardiography pre vs post implantation) and/or reduction in the number of hemolysis related transfusions.</measure>
    <time_frame>6 month following implantation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Absence of device -and/or procedure-related Serious Adverse Events (SAEs) including deaths, stroke (ischemic stroke that occurs within 24 hours following implantation), systemic embolism or device embolizations.</measure>
    <time_frame>6 month following implantation</time_frame>
  </primary_outcome>
  <enrollment type="Actual">144</enrollment>
  <condition>Mitral Paravalvular Leaks (PVL)</condition>
  <condition>Aortic Paravalvular Leaks (PVL)</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with aortic or mitral PVL&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        - Patients with PVL associated hemolysis, recurrent blood transfusions, or hemodynamically&#xD;
        significant heart failure&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
        The device is contraindicated for patients known to have any of the following:&#xD;
&#xD;
          -  Known coagulation dysfunction&#xD;
&#xD;
          -  Leak reversal with separate or significant residual or recurrent leak&#xD;
&#xD;
          -  Acute infection&#xD;
&#xD;
          -  Known intra-cardiac thrombi&#xD;
&#xD;
          -  Recent pelvic venous thrombosis&#xD;
&#xD;
          -  Recent myocardial infarction or a surgical bypass operation in the last 30 days&#xD;
&#xD;
          -  If adequate oral anticoagulation therapy / antiplatelet aggregation inhibition is not&#xD;
             possible post-procedurally&#xD;
&#xD;
          -  Intolerance of contrast agent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cardiovascular Department</name>
      <address>
        <city>Bergamo</city>
        <zip>24125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>October 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>April 13, 2022</last_update_submitted>
  <last_update_submitted_qc>April 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03003481
org study id: Occ2016_01
nct id: NCT03003481
lead sponsor: 
has dmc: No
Collect patient data and to monitor the clinical use (safety and efficacy) of the device
observational model: Case-Only
time perspective: Prospective
measure: Proper closure of the PVL (defined as Reduction in paravalvular regurgitation of ≥ one grade as assessed by echocardiography pre vs post implantation) and/or reduction in the number of hemolysis related transfusions.
time frame: 6 month following implantation
measure: Absence of device -and/or procedure-related Serious Adverse Events (SAEs) including deaths, stroke (ischemic stroke that occurs within 24 hours following implantation), systemic embolism or device embolizations.
time frame: 6 month following implantation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Sponsor