<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/NCT02226133</url>
  </required_header>
  <id_info>
    <org_study_id>D&amp;D CIP-0030</org_study_id>
    <nct_id>NCT02226133</nct_id>
  </id_info>
  <brief_title>Video-Assisted Left Atrial Appendage Exclusion Trial</brief_title>
  <acronym>VALET</acronym>
  <official_title>A Clinical Trial to Evaluate Safety and Effectiveness of the LAAx,Inc., TigerPaw System II LAA Exclusion Device for the Exclusion of the Left Atrial Appendage Via Video-Assisted Thoracoscopic Surgery (&quot;VATS&quot;)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LAAx, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LAAx, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Exclusion of the LAA(Left Atrial Appendage) using the TigerPaw II System with VATS technique&#xD;
      is safe and effective.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this confirmatory study is to demonstrate that the LAAx, Inc. TigerPaw® II&#xD;
      System can be safely and effectively used to exclude the Left Atrial Appendage (LAA) during&#xD;
      cardiac surgery utilizing thoracoscopic camera and light source and thus remove, from the&#xD;
      cleared indication for use, the direct vision limitation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    stopped for operational reasons&#xD;
  </why_stopped>
  <start_date>April 2015</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>rate of device related adverse and serious adverse events</measure>
    <time_frame>30 (plus or minus 7) days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exclusion of the Left Atrial Appendage</measure>
    <time_frame>30 days</time_frame>
    <description>Primary effectiveness will be measured by the percentage of patients with exclusion of the LAA assessed intraoperatively via endoscopic image and transesophageal echocardiography (TEE).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Heart Diseases</condition>
  <arm_group>
    <arm_group_label>Exclusion of Left Atrial Appendage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Left Atrial Appendage (LAA) occlusion, using the LAAx, Inc. TigerPaw® System II (delivery system and implant/Fastener) using VATS techniques,</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LAAx, Inc. TigerPaw® System II</intervention_name>
    <description>Exclusion of Left Atrial Appendage.</description>
    <arm_group_label>Exclusion of Left Atrial Appendage</arm_group_label>
    <other_name>LAAx,Inc. TigerPaw System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Greater than or equal to 18 years of age;&#xD;
&#xD;
          2. Capable and willing to give informed consent;&#xD;
&#xD;
          3. Able and willing to complete a 30 day ± 7 day follow-up evaluation;&#xD;
&#xD;
          4. Ejection fraction ≥ 30%;&#xD;
&#xD;
          5. Life expectancy of &gt; 1 year;&#xD;
&#xD;
          6. Stroke Risk (CHADS score of ≥ 1), CHADS scoring: CHF=1 point, Hypertension (or treated&#xD;
             hypertension) = 1 point, Age &gt; 75 = 1 point, Diabetes = 1 point, Prior stroke or TIA =&#xD;
             2 points;&#xD;
&#xD;
          7. Subjects suitable for elective Video-Assisted Thoracoscopic Surgical (VATS)&#xD;
             procedure(s) including, but not limited to, cardiac surgery for one or more of the&#xD;
             following:&#xD;
&#xD;
               1. mitral valve repair or replacement,&#xD;
&#xD;
               2. aortic valve repair or replacement,&#xD;
&#xD;
               3. tricuspid valve repair or replacement,&#xD;
&#xD;
               4. coronary artery bypass procedures,&#xD;
&#xD;
               5. concomitant surgical (ablation or cut and sew) Maze procedure and other ablation&#xD;
                  procedures&#xD;
&#xD;
               6. hybrid procedures including combination surgical and interventional procedures&#xD;
                  and surgical procedures with a combination of left and right thoracic access&#xD;
                  sites&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous cardiac surgery;&#xD;
&#xD;
          2. Active systemic or cutaneous infection or inflammation;&#xD;
&#xD;
          3. Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids not&#xD;
             including intermittent use of inhaled steroids for respiratory diseases;&#xD;
&#xD;
          4. Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's&#xD;
             disease or current platelet count &lt; 100,000 cells/mm3, baseline INR ≥1.8, or&#xD;
             fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24&#xD;
             hours);&#xD;
&#xD;
          5. Severe co-existing morbidities having a life expectancy of less than 1 year;&#xD;
&#xD;
          6. Currently involved in any other investigational clinical trials that have not&#xD;
             completed their primary endpoint or that may interfere with the TigerPaw study&#xD;
             results;&#xD;
&#xD;
          7. Thrombus in the LAA/LA;&#xD;
&#xD;
          8. NYHA Class IV heart failure symptoms;&#xD;
&#xD;
          9. Mental impairment or other conditions which may not allow the subject to understand&#xD;
             the nature, significance and scope of the study and to cooperate with follow-up&#xD;
             requirements;&#xD;
&#xD;
         10. Preoperative need for an intra-aortic balloon pump;&#xD;
&#xD;
         11. Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than&#xD;
             30%;&#xD;
&#xD;
         12. Females who are pregnant, planning to become pregnant within 1 month of the procedure,&#xD;
             or lactating;&#xD;
&#xD;
         13. Extreme morbid obesity (BMI greater than 45 kg/m2);&#xD;
&#xD;
         14. Any active medical condition that would preclude the patient from completing the study&#xD;
             or would result in an unreasonable risk;&#xD;
&#xD;
         15. Contraindication to Transesophageal Echocardiography (TEE);&#xD;
&#xD;
         16. Need for emergent cardiac surgery (e.g., cardiogenic shock);&#xD;
&#xD;
         17. Creatinine &gt;200 umol/L;&#xD;
&#xD;
         18. Renal failure requiring dialysis or hepatic failure;&#xD;
&#xD;
         19. A known drug and/or alcohol addiction;&#xD;
&#xD;
         20. Concurrent chemotherapy.&#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>ValleyCare Health System-Pleasanton</name>
      <address>
        <city>Pleasanton</city>
        <state>California</state>
        <zip>94588</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMD School of Medicine</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Heart Institute</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>18711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lankenau MOB East</name>
      <address>
        <city>Wynnewood</city>
        <state>Pennsylvania</state>
        <zip>19096</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 23, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>May 1, 2015</last_update_submitted>
  <last_update_submitted_qc>May 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 5, 2015</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>Heart Diseases</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/NCT02226133
org study id: D&D CIP-0030
nct id: NCT02226133
lead sponsor: 
has dmc: Yes
Exclusion of the LAA(Left Atrial Appendage) using the TigerPaw II System with VATS technique
      is safe and effective.
The objective of this confirmatory study is to demonstrate that the LAAx, Inc. TigerPaw® II
      System can be safely and effectively used to exclude the Left Atrial Appendage (LAA) during
      cardiac surgery utilizing thoracoscopic camera and light source and thus remove, from the
      cleared indication for use, the direct vision limitation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: rate of device related adverse and serious adverse events
time frame: 30 (plus or minus 7) days
measure: Exclusion of the Left Atrial Appendage
time frame: 30 days
description: Primary effectiveness will be measured by the percentage of patients with exclusion of the LAA assessed intraoperatively via endoscopic image and transesophageal echocardiography (TEE).
arm group label: Exclusion of Left Atrial Appendage
arm group type: Experimental
description: Left Atrial Appendage (LAA) occlusion, using the LAAx, Inc. TigerPaw® System II (delivery system and implant/Fastener) using VATS techniques,
intervention type: Device
intervention name: LAAx, Inc. TigerPaw® System II
description: Exclusion of Left Atrial Appendage.
arm group label: Exclusion of Left Atrial Appendage
other name: LAAx,Inc. TigerPaw System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Diseases