<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/NCT01721642</url>
  </required_header>
  <id_info>
    <org_study_id>CIP-DP1</org_study_id>
    <nct_id>NCT01721642</nct_id>
  </id_info>
  <brief_title>A Pilot Study to Evaluate the Safety and Efficacy of the Apica Access, Stabilization and Closure (ASC™) Device</brief_title>
  <official_title>A Pilot Study to Evaluate the Safety and Efficacy of the Apica Access, Stabilization and Closure (ASC™) Device During and After Transcatheter Aortic Valve Implantation (TAVI) Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Apica Cardiovascular Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Apica Cardiovascular Limited</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A pilot study to evaluate the safety and efficacy of the Apica Access, Stabilization, and&#xD;
      Closure Device for accessing and closing the left ventricular apex during and after&#xD;
      Transcatheter Aortic Valve Implantation (TAVI) procedures. Follow-up assessment will be made&#xD;
      post-procedure, at 30 days and 90 days as well as longer term follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Access safety</measure>
    <time_frame>Within 2 hours from initial skin incision</time_frame>
    <description>Observation of no myocardial tearing on entry of the device</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Closure safety</measure>
    <time_frame>Within 2 hours from initial skin incision</time_frame>
    <description>Observation of no acute post-procedural bleeding or pericardial effusion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigational device performance: LV function</measure>
    <time_frame>24 hours, 30 days and 90 days post-procedure</time_frame>
    <description>% LVEF no worse than baseline as assessed by echocardiography</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <arm_group>
    <arm_group_label>Apica Cardiovascular ASC Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Access, stabilisation and closure with the Apica Cardiovascular ASC Device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Apica Cardiovascular ASC Access, Stability and Closure Device</intervention_name>
    <description>Access, stabilisation and closure of trans-apical approach for TAVI</description>
    <arm_group_label>Apica Cardiovascular ASC Device</arm_group_label>
    <other_name>Apica Cardiovascular, ASC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject age ≥ 18 years of age.&#xD;
&#xD;
          -  Subjects will be selected in accordance with the investigating centers standard&#xD;
             operating procedures for TAVI subject selection and treatment. Subjects selected will&#xD;
             meet all of the TAVI inclusion criteria as follows:&#xD;
&#xD;
               -  Subject has Senile degenerative aortic stenosis with echocardiography derived&#xD;
                  criteria: mean gradient &gt; 40 mm Hg or jet velocity &gt; 4.0 m/s or an aortic valve&#xD;
                  area (AVA) of &lt; 0.8 cm2 (or AVA index &lt; 0.5 cm2/m2.&#xD;
&#xD;
               -  Subject is symptomatic due to aortic valve stenosis as demonstrated by NYHA&#xD;
                  Functional Class &gt; II.&#xD;
&#xD;
               -  Additive EuroScore &gt; 9&#xD;
&#xD;
               -  Aortic annulus diameter &gt; 21mm to &lt; 27mm by TEE&#xD;
&#xD;
               -  The subject or the subject's legal representative has been informed of the nature&#xD;
                  of the study, agrees to its provisions and has provided written informed consent.&#xD;
&#xD;
               -  The subject and the treating physician agree that the subject will return for all&#xD;
                  required post-procedure follow-up visits.&#xD;
&#xD;
               -  The subject, after formal consults by a cardiologist and two cardiovascular&#xD;
                  surgeons agreed that medical factors precluding operation, based on a conclusion&#xD;
                  that the probability of death or serious, irreversible morbidity exceeded the&#xD;
                  probability of meaningful improvement. Specifically the probability of death or&#xD;
                  serious, irreversible morbidity exceeded 50%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects will be selected in accordance with the investigating centers standard operating&#xD;
        procedures for TAVI subject selection and treatment. The following TAVI exclusion criteria&#xD;
        shall apply:&#xD;
&#xD;
          -  Evidence of an acute myocardial infarction &lt; 1 month before the intended treatment&#xD;
&#xD;
          -  Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified&#xD;
&#xD;
          -  Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant&#xD;
             aortic regurgitation &gt; 3+)&#xD;
&#xD;
          -  Pre-existing prosthetic heart valve in an position, prosthetic ring, or severe&#xD;
             (greater than 3+) mitral insufficiency&#xD;
&#xD;
          -  Blood dyscrasias as defined: Leukopenia, acute anemia, thrombocytopenia, history of&#xD;
             bleeding diathesis or coagulopathy.&#xD;
&#xD;
          -  Untreated clinically significant coronary artery disease requiring revascularization&#xD;
&#xD;
          -  Hemodynamic instability requiring inotropic therapy or mechanical hemodynamic support&#xD;
             devices&#xD;
&#xD;
          -  Need for emergency surgery for any reason&#xD;
&#xD;
          -  Hypertrophic cardiomyopathy with or without obstruction&#xD;
&#xD;
          -  Echocardiographic evidence of intracardiac mass, thrombus or vegetation&#xD;
&#xD;
          -  Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months&#xD;
&#xD;
          -  A known hypersensitivity of contraindication to asprin, heparin, ticlopidine (Ticlid),&#xD;
             or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately&#xD;
             pre-medicated&#xD;
&#xD;
          -  Recent (within 6 months) cerebrovascular accident or transient ischemic attack&#xD;
&#xD;
          -  Renal insufficiency and/or end stage renal disease requiring chronic dialysis.&#xD;
&#xD;
          -  Life expectancy &lt; 12 months due to non-cardiac co-morbid conditions.&#xD;
&#xD;
        The following ASC device exclusion criteria shall apply:&#xD;
&#xD;
          -  Subjects with &lt;10mm Left ventricular wall thickness at apical access site&#xD;
&#xD;
          -  LVEF &lt; 30%&#xD;
&#xD;
          -  Subject with previous DOR procedure&#xD;
&#xD;
          -  Subject access site has less than 2 cm squared &quot;fat&quot; free area under visual&#xD;
             observation&#xD;
&#xD;
          -  Subject has known Allergy or hypersensitivity to Titanium&#xD;
&#xD;
          -  Subject requires MR Imaging post procedure&#xD;
&#xD;
          -  Subject is Pregnant&#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>Thomas Walther, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kerckhoff Klinik</affiliation>
  </overall_official>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>June 26, 2014</last_update_submitted>
  <last_update_submitted_qc>June 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 27, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>access</keyword>
  <keyword>closure</keyword>
  <keyword>trans-apical</keyword>
  <keyword>trans-catheter aortic valve implantation</keyword>
  <keyword>TAVI</keyword>
  <keyword>trans-catheter aortic valve repair</keyword>
  <keyword>TAVR</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</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/NCT01721642
org study id: CIP-DP1
nct id: NCT01721642
lead sponsor: 
has dmc: Yes
A pilot study to evaluate the safety and efficacy of the Apica Access, Stabilization, and
      Closure Device for accessing and closing the left ventricular apex during and after
      Transcatheter Aortic Valve Implantation (TAVI) procedures. Follow-up assessment will be made
      post-procedure, at 30 days and 90 days as well as longer term follow-up.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Access safety
time frame: Within 2 hours from initial skin incision
description: Observation of no myocardial tearing on entry of the device
measure: Closure safety
time frame: Within 2 hours from initial skin incision
description: Observation of no acute post-procedural bleeding or pericardial effusion.
measure: Investigational device performance: LV function
time frame: 24 hours, 30 days and 90 days post-procedure
description: % LVEF no worse than baseline as assessed by echocardiography
arm group label: Apica Cardiovascular ASC Device
arm group type: Experimental
description: Access, stabilisation and closure with the Apica Cardiovascular ASC Device
intervention type: Device
intervention name: Apica Cardiovascular ASC Access, Stability and Closure Device
description: Access, stabilisation and closure of trans-apical approach for TAVI
arm group label: Apica Cardiovascular ASC Device
other name: Apica Cardiovascular, ASC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thomas Walther, Prof
role: Principal Investigator
affiliation: Kerckhoff Klinik
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis