<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/NCT01731210</url>
  </required_header>
  <id_info>
    <org_study_id>LCNA02 - LENEA</org_study_id>
    <nct_id>NCT01731210</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation Of The Nano Lv Lead System In Chronic Situation (LENEA)</brief_title>
  <acronym>LENEA</acronym>
  <official_title>Clinical Evaluation Of The Nano Lv Lead System In Chronic Situation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LivaNova</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LivaNova</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The LENEA study is an international, prospective, open label, non-randomized multicenter&#xD;
      clinical research study designed to assess the safety and effectiveness of the NANO LV lead&#xD;
      system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study stopped due to investigational device deficiency&#xD;
  </why_stopped>
  <start_date type="Actual">October 31, 2012</start_date>
  <completion_date type="Actual">December 19, 2013</completion_date>
  <phase>Phase 2/Phase 3</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>
    <intervention_model_description>NANO LV lead</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Freedom from left ventricular lead related complications through 1 month</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <enrollment type="Actual">9</enrollment>
  <condition>LV Lead</condition>
  <condition>LV Therapy</condition>
  <condition>LV Treatment</condition>
  <condition>LV Microcable</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>implantation of the new LV lead: NANO system.</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for&#xD;
             treatment of heart failure or life threatening ventricular tachyarrhythmia(s)&#xD;
&#xD;
          -  Receiving a new implant OR undergoing an upgrade from an existing ICD or pacemaker&#xD;
             implant with no prior implanted LV lead OR undergoing a new LV implant attempt&#xD;
             consecutive to a recent LV lead placement failure not related to coronary sinus&#xD;
             cannulation failure&#xD;
&#xD;
          -  Patient receiving the PARADYM RF CRT or PARADYM RF CRT SONR devices&#xD;
&#xD;
          -  Ability to provide informed consent for study participation and is willing and able to&#xD;
             comply with the prescribed follow-up tests and schedule of evaluations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial&#xD;
             infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance,&#xD;
             hypoxia or sepsis, uncorrected at the time of the enrolment;&#xD;
&#xD;
          -  Incessant Ventricular tachyarrhythmias;&#xD;
&#xD;
          -  Unstable angina, or acute MI , CABG , or PTCA within the past 4 weeks;&#xD;
&#xD;
          -  Correctable valvular disease that is the primary cause of heart failure;&#xD;
&#xD;
          -  Post heart transplant (patients who are waiting for a heart transplant are allowed in&#xD;
             the study);&#xD;
&#xD;
          -  Patient who had previously a permanently implanted LV lead;&#xD;
&#xD;
          -  Concurrent implant with another pacemaker or ICD (previously implanted pacemaker or&#xD;
             ICD devices should be removed prior to implant with the Paradym RF CRT-D or Paradym RF&#xD;
             CRT SONR);&#xD;
&#xD;
          -  Already included in another clinical study that could confound the results of this&#xD;
             study;&#xD;
&#xD;
          -  Life expectancy less than 1 year.&#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>CHU Charles Nicolle</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>March 12, 2018</last_update_submitted>
  <last_update_submitted_qc>March 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2018</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/NCT01731210
org study id: LCNA02 - LENEA
nct id: NCT01731210
lead sponsor: 
has dmc: No
The LENEA study is an international, prospective, open label, non-randomized multicenter
      clinical research study designed to assess the safety and effectiveness of the NANO LV lead
      system.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: NANO LV lead
primary purpose: Treatment
masking: None (Open Label)
measure: Freedom from left ventricular lead related complications through 1 month
time frame: 1 month
intervention type: Device
intervention name: implantation of the new LV lead: NANO system.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor