<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/NCT04417712</url>
  </required_header>
  <id_info>
    <org_study_id>LT/TS/45CE-04-01</org_study_id>
    <nct_id>NCT04417712</nct_id>
  </id_info>
  <brief_title>Lifetech MFO Post-Market Clinical Follow-Up Study</brief_title>
  <official_title>Lifetech KONAR-MF™ VSD Occluder Post-Market Clinical Follow-Up Study Clinical Investigation Plan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lifetech Scientific (Shenzhen) Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lifetech Scientific (Shenzhen) Co., Ltd.</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>
      The purpose of the study is to collect real world data on patient outcomes and evaluate the&#xD;
      procedural success and performance of the Lifetech KONAR-MF™ VSD Occluder for patients with&#xD;
      ventricular septal defect (VSD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a non-randomized prospective post-marketing clinical follow-up study (PMCFS) in order&#xD;
      to evaluate the feasibility and safety of Lifetech KONAR-MF™ VSD Occluder device used for&#xD;
      patients with ventricular septal defect. The implantation should be performed in accordance&#xD;
      to the instructions for use (IFU).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 4, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Actual">March 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Accurate success rate</measure>
    <time_frame>12 month</time_frame>
    <description>VSD closure without complication (dislocation, hemolysis, AVB, device related valve dysfunction, thrombosis, infection or endocarditis) and no or only mild residual shunt.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Procedure successful</measure>
    <time_frame>12 month</time_frame>
    <description>Optimal position of the VSD with appropriate closure rate at echocardiographic examination. No or only tiny or without residual shunt and absence of device related aortic or atrio ventricular valve reflux.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Ventricular Septal Defect</condition>
  <arm_group>
    <arm_group_label>Patients with ventricular septal defect</arm_group_label>
    <description>All patients who signed informed consent and are implanted with a KONAR-MF™ VSD Occluder device will undergo follow-up (FU) evaluations as per local hospital standard and corresponding IFU which is expected to be at the following time points post-implant:&#xD;
Before discharge 1-3 months after the Procedure 6 months after the procedure 12 months after the procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>KONAR-MF™ VSD Occluder</intervention_name>
    <description>All patients will be implanted with a KONAR-MF™ VSD Occluder in accordance with the instructions for use (IFU).</description>
    <arm_group_label>Patients with ventricular septal defect</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with ventricular septal defect.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients have a clinically relevant ventricular septum defect (VSD) by echocardiography&#xD;
        and/or X-ray examination according to current clinical standard and centre-specific&#xD;
        protocols.&#xD;
&#xD;
        The patient should be older than 6 months of age and the bodyweight heavier than 8kg.&#xD;
&#xD;
        Defect diameter (by 2D echocardiography): Size of the VSD is larger than or equal to 2mm&#xD;
        and less than 10mm.&#xD;
&#xD;
        Upper margin of VSD to aortic valve distance &gt;2 mm for models 6-4, 8-6, 10-8, 12-10, 14-12&#xD;
        and &gt;2.5mm for models 5-3, 7-5, 9-7, in case of PmVSD.&#xD;
&#xD;
        Only left to right shunt of the ventricular shunt.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Any contraindication mentioned in the corresponding IFU*.&#xD;
&#xD;
        The patient does present with an aortic valve prolapsing into the VSD.&#xD;
&#xD;
        Currently participating in other investigational drugs- or device studies.&#xD;
&#xD;
        The patient who is pregnant, planning to become pregnant, or breastfeeding.&#xD;
&#xD;
        Patients don't give informed written consent for the procedure.&#xD;
&#xD;
        Patient with other cardiac anomalies by surgery therapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephan Schubert</last_name>
    <role>Principal Investigator</role>
    <affiliation>Heart- and Diabetescenter NRW</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heart- and Diabetescenter NRW</name>
      <address>
        <city>Bad Oeynhausen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deutsches Herzzentrum Berlin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deutsches Herzzentrum München</name>
      <address>
        <city>Munich</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Policlinico San Donato</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>February 2, 2023</last_update_submitted>
  <last_update_submitted_qc>February 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 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 Septal Defects, Ventricular</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/NCT04417712
org study id: LT/TS/45CE-04-01
nct id: NCT04417712
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to collect real world data on patient outcomes and evaluate the
      procedural success and performance of the Lifetech KONAR-MF™ VSD Occluder for patients with
      ventricular septal defect (VSD).
This is a non-randomized prospective post-marketing clinical follow-up study (PMCFS) in order
      to evaluate the feasibility and safety of Lifetech KONAR-MF™ VSD Occluder device used for
      patients with ventricular septal defect. The implantation should be performed in accordance
      to the instructions for use (IFU).
observational model: Cohort
time perspective: Prospective
measure: Accurate success rate
time frame: 12 month
description: VSD closure without complication (dislocation, hemolysis, AVB, device related valve dysfunction, thrombosis, infection or endocarditis) and no or only mild residual shunt.
measure: Procedure successful
time frame: 12 month
description: Optimal position of the VSD with appropriate closure rate at echocardiographic examination. No or only tiny or without residual shunt and absence of device related aortic or atrio ventricular valve reflux.
arm group label: Patients with ventricular septal defect
description: All patients who signed informed consent and are implanted with a KONAR-MF™ VSD Occluder device will undergo follow-up (FU) evaluations as per local hospital standard and corresponding IFU which is expected to be at the following time points post-implant:
Before discharge 1-3 months after the Procedure 6 months after the procedure 12 months after the procedure
intervention type: Device
intervention name: KONAR-MF™ VSD Occluder
description: All patients will be implanted with a KONAR-MF™ VSD Occluder in accordance with the instructions for use (IFU).
arm group label: Patients with ventricular septal defect
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Months
maximum age: N/A
healthy volunteers: No
last name: Stephan Schubert
role: Principal Investigator
affiliation: Heart- and Diabetescenter NRW
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Italy
responsible party type: Sponsor
mesh term: Heart Septal Defects, Ventricular