<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/NCT01700244</url>
  </required_header>
  <id_info>
    <org_study_id>LCP004</org_study_id>
    <nct_id>NCT01700244</nct_id>
  </id_info>
  <brief_title>Evaluation of a New Cardiac Pacemaker</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanostim, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanostim, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An evaluation of a safety and performance of a new cardiac pacemaker&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">August 2013</completion_date>
  <primary_completion_date type="Anticipated">July 2013</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>Complication rate, where a complication is defined as a serious adverse device effect (SADE)</measure>
    <time_frame>90 days</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) Block</condition>
  <condition>Normal Sinus Rhythm With 2 or 3° AV or BBB Block</condition>
  <condition>Sinus Bradycardia With Infrequent Pauses or Unexplained Syncope With EP Findings</condition>
  <arm_group>
    <arm_group_label>Pacemaker</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pacemaker implant</intervention_name>
    <arm_group_label>Pacemaker</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must have one of the following clinical indications:&#xD;
&#xD;
               1. Chronic atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block&#xD;
                  (BBB block) ; or&#xD;
&#xD;
               2. Normal sinus rhythm with 2 or 3° AV or BBB block and a low level of physical&#xD;
                  activity or short expected lifespan (but at least one year); or&#xD;
&#xD;
               3. Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings;&#xD;
                  and&#xD;
&#xD;
          -  Subject ≥18 years of age;&#xD;
&#xD;
          -  Subject has life expectancy of at least one year;&#xD;
&#xD;
          -  Subject is not enrolled in another clinical investigation;&#xD;
&#xD;
          -  Subject is willing to comply with clinical investigation procedures and agrees to&#xD;
             return for all required follow-up visits, tests, and exams;&#xD;
&#xD;
          -  Subject has been informed of the nature of the study, agrees to its provisions and has&#xD;
             provided written informed consent, approved by the EC;&#xD;
&#xD;
          -  If female, for 3 months post-operative, subject will actively practice a contraception&#xD;
             method, or will practice abstinence, or is surgically sterilized, or is&#xD;
             postmenopausal.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pacemaker dependent;&#xD;
&#xD;
          -  Known pacemaker syndrome, have retrograde VA conduction or suffer a drop in arterial&#xD;
             blood pressure with the onset of ventricular pacing;&#xD;
&#xD;
          -  Hypersensitivity to &lt; 1 mg of dexamethasone sodium phosphate;&#xD;
&#xD;
          -  Mechanical tricuspid valve prosthesis;&#xD;
&#xD;
          -  Pre-existing pulmonary arterial (PA) hypertension or significant&#xD;
             physiologically-impairing lung disease;&#xD;
&#xD;
          -  Pre-existing pacing or defibrillation leads;&#xD;
&#xD;
          -  Current implantation of an implantable cardioverter defibrillator (ICD) or cardiac&#xD;
             resynchronization therapy (CRT);&#xD;
&#xD;
          -  Presence of implanted vena cava filter;&#xD;
&#xD;
          -  Presence of implanted leadless cardiac pacemaker;&#xD;
&#xD;
          -  Pregnant or breastfeeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johannes Sperzel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kerckhoff Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Na Homolce Hospital</name>
      <address>
        <city>Prague 5</city>
        <state>Prague</state>
        <zip>15000</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IKEM</name>
      <address>
        <city>Prague 4</city>
        <zip>140 21</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kerckhoff Clinic</name>
      <address>
        <city>Bad Nauheim</city>
        <zip>61231</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Hospital Munich</name>
      <address>
        <city>Munich</city>
        <zip>80636</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academic Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Antonius Hospital</name>
      <address>
        <city>Nieuwegein</city>
        <zip>3430</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMC Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3584</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czech Republic</country>
    <country>Germany</country>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>June 25, 2013</last_update_submitted>
  <last_update_submitted_qc>June 25, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 26, 2013</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>Syncope</mesh_term>
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Bradycardia</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/NCT01700244
org study id: LCP004
nct id: NCT01700244
lead sponsor: 
has dmc: Yes
An evaluation of a safety and performance of a new cardiac pacemaker
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complication rate, where a complication is defined as a serious adverse device effect (SADE)
time frame: 90 days
arm group label: Pacemaker
arm group type: Experimental
intervention type: Device
intervention name: Pacemaker implant
arm group label: Pacemaker
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Johannes Sperzel, MD
role: Principal Investigator
affiliation: Kerckhoff Clinic
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Czech Republic
country: Germany
country: Netherlands
responsible party type: Sponsor
mesh term: Syncope
mesh term: Atrial Fibrillation
mesh term: Bradycardia