<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/NCT02255851</url>
  </required_header>
  <id_info>
    <org_study_id>CP10879</org_study_id>
    <nct_id>NCT02255851</nct_id>
  </id_info>
  <brief_title>Sentinel(TM) Post-Market Registry</brief_title>
  <official_title>Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Claret Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Claret Medical</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the&#xD;
      CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve&#xD;
      stenosis indicated for TAVR.&#xD;
&#xD;
      Subjects enrolled in the registry will undergo TAVR + Sentinel. Basic demographic information&#xD;
      and detailed procedural data will be captured and documented in a registry case report form.&#xD;
&#xD;
      All Sentinel filters will be sent for histopathology at an independent core-lab.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Primary Observational Endpoint</measure>
    <time_frame>Post-Procedure (day 1)</time_frame>
    <description>Capture rate, debris volume and histopathology analysis at day 1.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Transcatheter Aortic Valve Replacement</condition>
  <condition>Severe Symptomatic Calcified Native Aortic Valve Stenosis</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <description>TAVR + SENTINEL (Cerebral Protection System)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SENTINEL (Cerebral Protection System)</intervention_name>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Capture and histopathology analysis of embolic debris. (Thrombus, valve tissue, amorphous&#xD;
      calcium, etc.)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The registry population comprises subjects with severe symptomatic calcified native aortic&#xD;
        valve stenosis who are selected for TAVR by heart team consensus and treated with CE-Marked&#xD;
        TAVR devices.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Approved indications for commercially available CE-Marked TAVR devices.&#xD;
&#xD;
          2. Compatible left common carotid artery (6.5 - 10 mm) and brachiocephalic artery (9 - 15&#xD;
             mm) diameters without significant stenosis (&gt; 70%).&#xD;
&#xD;
          3. The subject or the subject's legal representative has been informed of the nature of&#xD;
             the registry, agrees to its provisions and has provided written informed consent as&#xD;
             approved by the Ethics Committee of the respective site.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Vasculature in the right extremity precluding 6Fr sheath radial/brachial access&#xD;
&#xD;
          2. Inadequate circulation to the right extremity as evidenced by signs of artery&#xD;
             occlusion or absence of radial or brachial pulse&#xD;
&#xD;
          3. Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity&#xD;
             vasculature&#xD;
&#xD;
          4. Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who&#xD;
             will refuse transfusion&#xD;
&#xD;
          5. Excessive tortuosity in the right radial/brachial/subclavian artery preventing&#xD;
             Sentinel device access and insertion&#xD;
&#xD;
          6. Patient whose brachiocephalic or left carotid artery reveals significant stenosis,&#xD;
             ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium&#xD;
&#xD;
          7. Currently participating in an investigational drug or investigational (non CE-mark)&#xD;
             device study&#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>Christoph Naber, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Elisabeth-Krankenhaus Essen GmbH, Essen, Germany</affiliation>
  </overall_official>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>May 22, 2018</last_update_submitted>
  <last_update_submitted_qc>May 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>selected for TAVR by heart team consensus</keyword>
  <keyword>treated with CE-Marked TAVR devices</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/NCT02255851
org study id: CP10879
nct id: NCT02255851
lead sponsor: 
has dmc: No
The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the
      CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve
      stenosis indicated for TAVR.

      Subjects enrolled in the registry will undergo TAVR + Sentinel. Basic demographic information
      and detailed procedural data will be captured and documented in a registry case report form.

      All Sentinel filters will be sent for histopathology at an independent core-lab.
observational model: Cohort
time perspective: Prospective
measure: Primary Observational Endpoint
time frame: Post-Procedure (day 1)
description: Capture rate, debris volume and histopathology analysis at day 1.
arm group label: Treatment Group
description: TAVR + SENTINEL (Cerebral Protection System)
intervention type: Device
intervention name: SENTINEL (Cerebral Protection System)
arm group label: Treatment Group
Capture and histopathology analysis of embolic debris. (Thrombus, valve tissue, amorphous
      calcium, etc.)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christoph Naber, MD
role: Principal Investigator
affiliation: Elisabeth-Krankenhaus Essen GmbH, Essen, Germany
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis