<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/NCT03793296</url>
  </required_header>
  <id_info>
    <org_study_id>AMCCV2018-11</org_study_id>
    <nct_id>NCT03793296</nct_id>
  </id_info>
  <brief_title>Percutaneous Device Closure for Significant Paravalvular Leakage After Transcatheter or Surgical Valve Replacement</brief_title>
  <acronym>PVL closure</acronym>
  <official_title>Percutaneous Device Closure for Significant Paravalvular Leakage After Transcatheter or Surgical Valve replacement_Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seung-Jung Park</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CardioVascular Research Foundation, Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Asan Medical Center</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 evaluates the effectiveness and safety of Percutaneous Device Closure for&#xD;
      Significant Paravalvular Leakage after transcatheter or surgical valve replacement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    At sponsor's discretion&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 31, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">June 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>Degree of para-valvular leakage</measure>
    <time_frame>1 month</time_frame>
    <description>classified as none, mild, moderate or severe by doppler echocardiography according to Valve Academic Research Consortium-2(VARC-2)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Event rate of all cause death</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of cardiac death</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of stroke</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of myocardial infarction</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of rehospitalization</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of infection</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Valve related infection or infective endocarditis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of acute kidney injury</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of vascular complication</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of bleeding</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event rate of device success</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Cardiac Valves</condition>
  <condition>Heart Valve Diseases</condition>
  <condition>Valvular Insufficiency</condition>
  <arm_group>
    <arm_group_label>Paravalvular leak</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After transcatheter- or surgical valve replacement</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Percutaneous Device Closure: Vascular plug</intervention_name>
    <description>percutaneous transcatheter approach into cardiac valve</description>
    <arm_group_label>Paravalvular leak</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Significant Paravalvular Leakage After Transcatheter or Surgical Valve Replacement&#xD;
&#xD;
          -  Required treatment of paravalvular leakage due to heart failure or hemolysis&#xD;
&#xD;
          -  There is a formal agreement of heart team as following&#xD;
&#xD;
               -  predicted high-risk (STS score ≥8 OR Logistic EuroSCORE ≥20% OR operative&#xD;
                  mortality is ≥15%)&#xD;
&#xD;
          -  Inoperable status due to old age or frailty&#xD;
&#xD;
          -  Written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Risk of valve embolization because of valve dehiscence or instability&#xD;
&#xD;
          -  Acute myocardial ischemia (enzyme elevation, ST elevation on EKG(electrocardiogram),&#xD;
             or chest pain/discomfort)&#xD;
&#xD;
          -  Evidence of intracardiac mass, thrombus or vegetation on Transthoracic/Transesophageal&#xD;
             echocardiographic study&#xD;
&#xD;
          -  Life expectancy less than 6 months due to non-cardiac disease&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 30, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Seung-Jung Park</investigator_full_name>
    <investigator_title>Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea</investigator_title>
  </responsible_party>
  <keyword>Paravalvular leak</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Valve Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03793296
org study id: AMCCV2018-11
nct id: NCT03793296
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the effectiveness and safety of Percutaneous Device Closure for
      Significant Paravalvular Leakage after transcatheter or surgical valve replacement.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Degree of para-valvular leakage
time frame: 1 month
description: classified as none, mild, moderate or severe by doppler echocardiography according to Valve Academic Research Consortium-2(VARC-2)
measure: Event rate of all cause death
time frame: up to 5 years
measure: Event rate of cardiac death
time frame: up to 5 years
measure: Event rate of stroke
time frame: up to 5 years
measure: Event rate of myocardial infarction
time frame: up to 5 years
measure: Event rate of rehospitalization
time frame: up to 5 years
measure: Event rate of infection
time frame: up to 5 years
description: Valve related infection or infective endocarditis
measure: Event rate of acute kidney injury
time frame: 1 month
measure: Event rate of vascular complication
time frame: 1 month
measure: Event rate of bleeding
time frame: 1 month
measure: Event rate of device success
time frame: 1 month
arm group label: Paravalvular leak
arm group type: Experimental
description: After transcatheter- or surgical valve replacement
intervention type: Device
intervention name: Percutaneous Device Closure: Vascular plug
description: percutaneous transcatheter approach into cardiac valve
arm group label: Paravalvular leak
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Asan Medical Center
investigator full name: Seung-Jung Park
investigator title: Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
mesh term: Heart Valve Diseases
sharing ipd: Undecided