<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/NCT02996929</url>
  </required_header>
  <id_info>
    <org_study_id>Leadexx CL-001</org_study_id>
    <nct_id>NCT02996929</nct_id>
  </id_info>
  <brief_title>Safety and Performance of LeadExx LC System in Lead Extraction</brief_title>
  <official_title>Prospective, Investigational Study to Assess the Safety and Performance of LeadExx LC System in Lead Extraction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LeadExx Cardiac Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LeadExx Cardiac Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study's main purpose is to evaluate the safety and performance of the LeadExx LC System&#xD;
      and its ability to safely extract leads.&#xD;
&#xD;
      The study will enroll 10 patients scheduled for CIED lead extraction. The decision upon lead&#xD;
      extraction will be based upon the applicable Heart Rhythm Society guidelines or European&#xD;
      Heart Rhythm Association (EHRA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use of implantable cardiac devices has been exponentially increasing, and lead extraction&#xD;
      has become a necessary procedure. But lead extraction has potentially serious complications,&#xD;
      including venous or myocardial tear, cardiac tamponade, and even death. Powered sheaths, such&#xD;
      as Excimer laser or a radiofrequency system, have been used for extraction of ICD or&#xD;
      pacemaker leads. However, the Heart Rhythm Society (HRS) has stated that &quot;possible predictors&#xD;
      of major complications were implant duration of the oldest lead, female gender, ICD lead&#xD;
      removal, and use of the laser extraction technique, multiple leads, and calcified leads&quot;.&#xD;
&#xD;
      To reduce the risk of the lead extraction procedure and therefore reduce the number of&#xD;
      abandoned leads, LeadExx had developed its system.&#xD;
&#xD;
      The LC system is an active disposable system provided sterile for single use. The system is&#xD;
      comprised of the following two main parts:&#xD;
&#xD;
      a. Dilation Unit (DU) - (invasive, sterile) b. Control Unit- (CU) - (non-invasive, sterile&#xD;
      fluid path) The physical connection between the units is achieved by 3 Luer locks that&#xD;
      connect the CU Solenoids' output to 3 flexible tubes at the proximal end of the DU.&#xD;
&#xD;
        1. Dilation Unit (DU):&#xD;
&#xD;
           The dilation unit is an invasive sterile unit, comprised of a dilation tip and a&#xD;
           connecting shaft. The unit is activated using a hydraulic mechanism.&#xD;
&#xD;
           The dilation tip is threaded over the lead, inserted into the vessel together with its&#xD;
           connecting shaft and while advancing along the lead, dilates the surrounding tissue and&#xD;
           ultimately enables the lead removal from the vein.&#xD;
&#xD;
        2. Control Unit (CU):&#xD;
&#xD;
      The Control Unit is a non-invasive fluid path sterile unit, comprised of various off the&#xD;
      shelf modules . The unit is being filled with sterile Saline just prior to its operation and&#xD;
      by synchronizing the transfer of the Saline into the DU controls its advancement. I&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <completion_date type="Anticipated">April 2017</completion_date>
  <primary_completion_date type="Anticipated">February 2017</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>Adverse events</measure>
    <time_frame>1 month</time_frame>
    <description>Monitoring Adverse events that are related to the extraction procedure, or the extraction system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Performance</measure>
    <time_frame>During procedure</time_frame>
    <description>Secondary Objectives:&#xD;
To assess the ease of use by questions&#xD;
Duration of procedure,&#xD;
Physician satisfaction by questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Practical removal of intact lead</measure>
    <time_frame>During procedure</time_frame>
    <description>Performance primary objective:&#xD;
To verify that the attachment and advancement of the LC system enables a safe and practical removal of the Lead.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Implant Site Infection</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects who are scheduled for CIED lead extraction with the LC system</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LC System</intervention_name>
    <description>Subjects will undergo CIED lead extraction with the LC system</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female 18-75 years old.&#xD;
&#xD;
          2. Scheduled for an CIED lead extraction upon current guidelines&#xD;
&#xD;
          3. Willing and able to sign the informed consent.&#xD;
&#xD;
          4. Lead implant duration more than 1 year and less than 5 years.&#xD;
&#xD;
          5. Patient with Lead size 7F&#xD;
&#xD;
          6. BMI 22-32&#xD;
&#xD;
          7. Number of implanted leads 1-3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lead implant duration is less than 1 year or more than 5 years.&#xD;
&#xD;
          2. Patients with acute and chronic lead infections&#xD;
&#xD;
          3. Pericardial or subcutaneous CIED systems (without trans venous CIED lead)&#xD;
&#xD;
          4. Pregnant or lactating.&#xD;
&#xD;
          5. Patients with expected survival of less than 1 year.&#xD;
&#xD;
          6. Subjects who are participating in another clinical study.&#xD;
&#xD;
          7. Subjects who are unable or unwilling to follow the study schedule of visits.&#xD;
&#xD;
          8. Contraindication to administration of iodinated contrast (creatinine &gt; 2.0 or contrast&#xD;
             allergy)&#xD;
&#xD;
          9. Patients with a history of venous thromboembolism, coagulopathy or malignancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eyal Nof, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheba Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eyal Nof, Dr.</last_name>
    <phone>972-3-530-3810</phone>
    <email>Eyal.Nof@sheba.health.gov.il</email>
  </overall_contact>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>December 14, 2016</last_update_submitted>
  <last_update_submitted_qc>December 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT02996929
org study id: Leadexx CL-001
nct id: NCT02996929
lead sponsor: 
has dmc: No
The study's main purpose is to evaluate the safety and performance of the LeadExx LC System
      and its ability to safely extract leads.

      The study will enroll 10 patients scheduled for CIED lead extraction. The decision upon lead
      extraction will be based upon the applicable Heart Rhythm Society guidelines or European
      Heart Rhythm Association (EHRA).
The use of implantable cardiac devices has been exponentially increasing, and lead extraction
      has become a necessary procedure. But lead extraction has potentially serious complications,
      including venous or myocardial tear, cardiac tamponade, and even death. Powered sheaths, such
      as Excimer laser or a radiofrequency system, have been used for extraction of ICD or
      pacemaker leads. However, the Heart Rhythm Society (HRS) has stated that "possible predictors
      of major complications were implant duration of the oldest lead, female gender, ICD lead
      removal, and use of the laser extraction technique, multiple leads, and calcified leads".

      To reduce the risk of the lead extraction procedure and therefore reduce the number of
      abandoned leads, LeadExx had developed its system.

      The LC system is an active disposable system provided sterile for single use. The system is
      comprised of the following two main parts:

      a. Dilation Unit (DU) - (invasive, sterile) b. Control Unit- (CU) - (non-invasive, sterile
      fluid path) The physical connection between the units is achieved by 3 Luer locks that
      connect the CU Solenoids' output to 3 flexible tubes at the proximal end of the DU.

        1. Dilation Unit (DU):

           The dilation unit is an invasive sterile unit, comprised of a dilation tip and a
           connecting shaft. The unit is activated using a hydraulic mechanism.

           The dilation tip is threaded over the lead, inserted into the vessel together with its
           connecting shaft and while advancing along the lead, dilates the surrounding tissue and
           ultimately enables the lead removal from the vein.

        2. Control Unit (CU):

      The Control Unit is a non-invasive fluid path sterile unit, comprised of various off the
      shelf modules . The unit is being filled with sterile Saline just prior to its operation and
      by synchronizing the transfer of the Saline into the DU controls its advancement. I
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse events
time frame: 1 month
description: Monitoring Adverse events that are related to the extraction procedure, or the extraction system
measure: Performance
time frame: During procedure
description: Secondary Objectives:
To assess the ease of use by questions
Duration of procedure,
Physician satisfaction by questions
measure: Practical removal of intact lead
time frame: During procedure
description: Performance primary objective:
To verify that the attachment and advancement of the LC system enables a safe and practical removal of the Lead.
arm group label: Study group
arm group type: Experimental
description: Subjects who are scheduled for CIED lead extraction with the LC system
intervention type: Device
intervention name: LC System
description: Subjects will undergo CIED lead extraction with the LC system
arm group label: Study group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Eyal Nof, Dr.
role: Principal Investigator
affiliation: Sheba Medical Center
last name: Eyal Nof, Dr.
phone: 972-3-530-3810
email: Eyal.Nof@sheba.health.gov.il
responsible party type: Sponsor
sharing ipd: No