<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/NCT03040622</url>
  </required_header>
  <id_info>
    <org_study_id>16-2583</org_study_id>
    <nct_id>NCT03040622</nct_id>
  </id_info>
  <brief_title>The Evaluation of Thrombogenicity in Patients Undergoing WATCHMAN Left Atrial Appendage Closure Trial</brief_title>
  <official_title>The Evaluation of Thrombogenicity in Patients Undergoing WATCHMAN Left Atrial Appendage Closure Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inova Health Care Services</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Inova Health Care Services</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate thrombogenicity in patients undergoing left atrial appendage closure&#xD;
      using the WATCHMAN device. Parameters of thrombosis and platelet function, as well as other&#xD;
      bio-markers, will be measure before, during, and after WATCHMAN implantation at several&#xD;
      follow up visits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 15, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Platelet Aggregation measured by Light Transmissions Aggregometry with 5 and 20 µM ADP, 2mM AA, and 4ug/ml collagen as agonists.</measure>
    <time_frame>12 Months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Thrombelastography preformed to determine physical characteristics of the platelet-fibrin clot.</measure>
    <time_frame>12 Months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Thrombin generation measured by thrombogram (CAT assay) to identify patients with hypo- or hypercoagulable phenotypes.</measure>
    <time_frame>12 Months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Biomarker measurements to determine any that may predict thrombo-embolic events.</measure>
    <time_frame>12 Months</time_frame>
    <description>Biomarkers include fibrinogen, d-dimer, hsCRP, PAI, Urninary TxB2, sST2, and Galectin-3.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Left Atrial Thrombus measured by transesophageal echocardiography (TEE).</measure>
    <time_frame>12 Months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Major or clinically-relevant non-major bleeding.</measure>
    <time_frame>12 Months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of high on-treatment platelet reactivity.</measure>
    <time_frame>12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of low, medium, and high risk thrombogenic phenotype within the study population.</measure>
    <time_frame>12 Months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Left Atrial Appendage Closure</condition>
  <condition>WATCHMAN Device Implantation</condition>
  <arm_group>
    <arm_group_label>Watchman Left Atrial Appendage Closure</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WATCHMAN Left Atrial Appendage Closure</intervention_name>
    <description>WATCHMAN Left Atrial Appendage Closure</description>
    <arm_group_label>Watchman Left Atrial Appendage Closure</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects &gt;18 years of age scheduled for left atrial appendage closure procedure with the&#xD;
        WATCHMAN device.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject indicated and scheduled for WATCHMAN device implantation at IHVI.&#xD;
&#xD;
          -  Subject may be of either sex and of any race, and must be &gt;18 years of age.&#xD;
&#xD;
          -  Subject must be willing and able to give appropriate informed consent.&#xD;
&#xD;
          -  The subject is able to read and has signed and dated the informed consent document&#xD;
             including authorization permitting release of personal health information approved by&#xD;
             the investigator's Institutional Review Board (IRB).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Subjects with contraindications for WATCHMAN device implantation Intracardiac thrombus is&#xD;
        visualized by echocardiographic imaging An atrial septal defect repair or closure device or&#xD;
        a patent foramen ovale repair or closure device is present The LAA anatomy will not&#xD;
        accommodate a device Any of the customary contraindications for other percutaneous&#xD;
        catheterization procedures (e.g., patient size too small to accommodate TEE probe or&#xD;
        required catheters) or conditions (e.g., active infection, bleeding disorder) are present.&#xD;
&#xD;
        There are contraindications to the use of warfarin, aspirin, or clopidogrel The patient has&#xD;
        a known hypersensitivity to any portion of the device material or the individual components&#xD;
        such that the use of the WATCHMAN Device is contraindicated&#xD;
&#xD;
          -  Concurrent participation in any investigational study.&#xD;
&#xD;
          -  Subject likely to not be available to complete all protocol-required study visits or&#xD;
             procedures, to the best of the subject's and investigator's knowledge&#xD;
&#xD;
          -  History or evidence of any other clinically significant disorder, condition, or&#xD;
             disease other than those outlined above that, in the opinion of the investigator, may&#xD;
             compromise the ability of the subject to give written informed consent, would pose a&#xD;
             risk to subject safety or interfere with the study evaluation, procedures, or&#xD;
             completion.&#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>Inova Fairfax Hospital</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>October 8, 2019</last_update_submitted>
  <last_update_submitted_qc>October 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>WATCHMAN</keyword>
  <keyword>Left Atrial Appendage Closure</keyword>
  <keyword>Thrombosis</keyword>
  <keyword>Platelet Function</keyword>
  <pending_results>
    <submitted>April 5, 2022</submitted>
    <returned>October 24, 2022</returned>
    <submitted>November 18, 2022</submitted>
  </pending_results>
  <!-- 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/NCT03040622
org study id: 16-2583
nct id: NCT03040622
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
This study will evaluate thrombogenicity in patients undergoing left atrial appendage closure
      using the WATCHMAN device. Parameters of thrombosis and platelet function, as well as other
      bio-markers, will be measure before, during, and after WATCHMAN implantation at several
      follow up visits.
observational model: Case-Only
time perspective: Prospective
measure: Platelet Aggregation measured by Light Transmissions Aggregometry with 5 and 20 µM ADP, 2mM AA, and 4ug/ml collagen as agonists.
time frame: 12 Months
measure: Thrombelastography preformed to determine physical characteristics of the platelet-fibrin clot.
time frame: 12 Months
measure: Thrombin generation measured by thrombogram (CAT assay) to identify patients with hypo- or hypercoagulable phenotypes.
time frame: 12 Months
measure: Biomarker measurements to determine any that may predict thrombo-embolic events.
time frame: 12 Months
description: Biomarkers include fibrinogen, d-dimer, hsCRP, PAI, Urninary TxB2, sST2, and Galectin-3.
measure: Left Atrial Thrombus measured by transesophageal echocardiography (TEE).
time frame: 12 Months
measure: Major or clinically-relevant non-major bleeding.
time frame: 12 Months
measure: Frequency of high on-treatment platelet reactivity.
time frame: 12 Months
measure: Frequency of low, medium, and high risk thrombogenic phenotype within the study population.
time frame: 12 Months
arm group label: Watchman Left Atrial Appendage Closure
intervention type: Device
intervention name: WATCHMAN Left Atrial Appendage Closure
description: WATCHMAN Left Atrial Appendage Closure
arm group label: Watchman Left Atrial Appendage Closure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
submitted: April 5, 2022
returned: October 24, 2022
submitted: November 18, 2022