<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/NCT01722591</url>
  </required_header>
  <id_info>
    <org_study_id>CLN-PRO-01</org_study_id>
    <nct_id>NCT01722591</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of the Cardiapex Percutaneous Trans-apical Access and Closure System</brief_title>
  <official_title>A Prospective, Multicenter, Uncontrolled Study to Evaluate the Safety and Efficacy of the Cardiapex Percutaneous Trans-apical Access and Closure System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiapex Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cardiapex Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective, multicenter, uncontrolled study to evaluate the safety and efficacy of the&#xD;
      Cardiapex percutaneous trans-apical access and closure system. The Cardiapex device intended&#xD;
      for percutaneous access and closure of the left ventricular apex in conjunction with&#xD;
      transapical Transcatheter Aortic Valve Implantation (TAVI).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>January 2013</start_date>
  <primary_completion_date type="Actual">February 2014</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Successful performance of percutaneous transapical TAVI defined as: &quot;Successful percutaneous transapical access and deployment of a single prosthetic heart valve&quot;</measure>
    <time_frame>Outcome measure assessed during the TAVI surgical procedure - an average of 3 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>≤30 day apical bleeding requiring surgical intervention</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">38</enrollment>
  <condition>Transapical Transcatheter Aortic Valve Implantation</condition>
  <arm_group>
    <arm_group_label>Cardiapex device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of the Cardiapex device in the context of transapical TAVI procedures</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cardiapex device</intervention_name>
    <description>Cardiapex percutaneous transapical access and closure system</description>
    <arm_group_label>Cardiapex device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient scheduled for transapical TAVI&#xD;
&#xD;
          -  Patient ≥ 70 years of age&#xD;
&#xD;
          -  Patient able to give informed written consent&#xD;
&#xD;
          -  Patient able to attend follow up examinations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Scheduled concomitant non-TAVI cardiac procedure&#xD;
&#xD;
          -  Patient with Left Ventricular Ejection Fraction (LVEF) &lt; 30% at time of enrollment&#xD;
&#xD;
          -  Patient with known apical infarcted area&#xD;
&#xD;
          -  Patient with a distinct large vessel right at the anatomical apex9 (based on&#xD;
             pre-operative coronary angiography&#xD;
&#xD;
          -  Patients with known lung tissue surrounding the apex and possibly interfering with the&#xD;
             in-out puncture (based on preoperative gated CT assessment&#xD;
&#xD;
          -  Patient with contra-indications to transapical TAVI&#xD;
&#xD;
          -  Patient's inability to tolerate or comply with normal post-surgical drug regimen&#xD;
&#xD;
          -  Patient's inability to comply with required follow-ups, including echocardiography&#xD;
&#xD;
          -  Patient participation in other clinical trials within previous month&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kerckhoff Clinic</name>
      <address>
        <city>Bad Nauheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamburg University Heart Center</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <removed_countries>
    <country>Canada</country>
  </removed_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>February 3, 2015</last_update_submitted>
  <last_update_submitted_qc>February 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 4, 2015</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/NCT01722591
org study id: CLN-PRO-01
nct id: NCT01722591
lead sponsor: 
has dmc: No
A prospective, multicenter, uncontrolled study to evaluate the safety and efficacy of the
      Cardiapex percutaneous trans-apical access and closure system. The Cardiapex device intended
      for percutaneous access and closure of the left ventricular apex in conjunction with
      transapical Transcatheter Aortic Valve Implantation (TAVI).
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Successful performance of percutaneous transapical TAVI defined as: "Successful percutaneous transapical access and deployment of a single prosthetic heart valve"
time frame: Outcome measure assessed during the TAVI surgical procedure - an average of 3 hours
measure: ≤30 day apical bleeding requiring surgical intervention
time frame: 30 days
arm group label: Cardiapex device
arm group type: Experimental
description: Use of the Cardiapex device in the context of transapical TAVI procedures
intervention type: Device
intervention name: Cardiapex device
description: Cardiapex percutaneous transapical access and closure system
arm group label: Cardiapex device
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Germany
country: Canada
responsible party type: Sponsor