<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/NCT03759418</url>
  </required_header>
  <id_info>
    <org_study_id>005</org_study_id>
    <nct_id>NCT03759418</nct_id>
  </id_info>
  <brief_title>Left Atrial Appendage Ligation Using the Atriclip Device</brief_title>
  <official_title>Left Atrial Appendage Ligation Using the Atriclip Device; Single Center Study of Device Safety and Efficacy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Helena Hospital Coon Joint Replacement Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AtriCure, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Adventist Heart and Vascular Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Helena Hospital Coon Joint Replacement Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to collect data regarding ligation of the left atrial appendage&#xD;
      at least 12 months after surgery for patients that had exclusion of the left atrial appendage&#xD;
      as a primary minimally invasive procedure or in conjunction with other open cardiac or&#xD;
      minimally invasive cardiac procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to collect data regarding ligation of the left atrial appendage&#xD;
      at least 12 months after surgery for patients that had exclusion of the left atrial appendage&#xD;
      as a primary minimally invasive procedure or in conjunction with other open cardiac or&#xD;
      minimally invasive cardiac procedures. The patient will undergo a transesophageal&#xD;
      echocardiogram (TEE) to collect the following data: Left Ventricular Ejection Fraction; Left&#xD;
      Atrial diameter size; confirmation of Left Atrial Appendage exclusion defined by the absence&#xD;
      of left atrial to LAA (left atrial appendage) communication measured in millimeters and&#xD;
      absence of LAA pocket measured in millimeters; presence of thrombus in left atrium.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2016</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>12 month follow up with complete exclusion of the Left Atrial Appendage</measure>
    <time_frame>365 days to complete</time_frame>
    <description>The complete exclusion is defined by the lack of fluid communication between the left atrium and left atrial appendage at &lt;/= 12 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Any signs of thrombus in the left atrium</measure>
    <time_frame>365 days to compete</time_frame>
    <description>Any signs of thrombus in the left atrium</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of Cerebrovascular accident/transient Ischemic Attack</measure>
    <time_frame>365 days to complete</time_frame>
    <description>Occurrence of Cerebrovascular accident/transient ischemic attack postoperative ,/= 12 months</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Left Atrial Appendage Ligation</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>exclusion of the left atrial appendage</intervention_name>
    <description>A trans esophageal echocardiogram will be performed to assess the Atriclip device in the closure of the left atrial appendage in patients that had surgery at least 12 months ago.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients who had an Atriclip placed to exclude the left atrial appendage.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patient who had a heart procedure where an Atriclip device was deployed as&#xD;
             the primary or secondary procedure between 3/2013-12/20/2016&#xD;
&#xD;
          -  Patient is willing to undergo a trans esophageal echocardiogram, or if unable a CT&#xD;
             angiogram&#xD;
&#xD;
          -  If female, must be of non-childbearing potential or have a negative pregnancy test&#xD;
             within 7 days prior to the procedure&#xD;
&#xD;
          -  Patient is willing to sign an IRB approved Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient did not have an Atriclip device as part of the surgical procedure between&#xD;
             3/2013 and 12/2016.&#xD;
&#xD;
          -  Patient is unwilling or unable to undergo trans esophageal echocardiogram with general&#xD;
             anesthesia or a CT angiogram&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gansevoort Dunnington, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Helena Hospital Adventist Heart Institute</affiliation>
  </overall_official>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 10, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Left Atrial Appendage Ligation</keyword>
  <keyword>Atriclip</keyword>
  <keyword>atrial fibrillation</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03759418
org study id: 005
nct id: NCT03759418
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of the study is to collect data regarding ligation of the left atrial appendage
      at least 12 months after surgery for patients that had exclusion of the left atrial appendage
      as a primary minimally invasive procedure or in conjunction with other open cardiac or
      minimally invasive cardiac procedures.
The purpose of this study is to collect data regarding ligation of the left atrial appendage
      at least 12 months after surgery for patients that had exclusion of the left atrial appendage
      as a primary minimally invasive procedure or in conjunction with other open cardiac or
      minimally invasive cardiac procedures. The patient will undergo a transesophageal
      echocardiogram (TEE) to collect the following data: Left Ventricular Ejection Fraction; Left
      Atrial diameter size; confirmation of Left Atrial Appendage exclusion defined by the absence
      of left atrial to LAA (left atrial appendage) communication measured in millimeters and
      absence of LAA pocket measured in millimeters; presence of thrombus in left atrium.
observational model: Case-Only
time perspective: Retrospective
measure: 12 month follow up with complete exclusion of the Left Atrial Appendage
time frame: 365 days to complete
description: The complete exclusion is defined by the lack of fluid communication between the left atrium and left atrial appendage at </= 12 months
measure: Any signs of thrombus in the left atrium
time frame: 365 days to compete
description: Any signs of thrombus in the left atrium
measure: Occurrence of Cerebrovascular accident/transient Ischemic Attack
time frame: 365 days to complete
description: Occurrence of Cerebrovascular accident/transient ischemic attack postoperative ,/= 12 months
intervention type: Device
intervention name: exclusion of the left atrial appendage
description: A trans esophageal echocardiogram will be performed to assess the Atriclip device in the closure of the left atrial appendage in patients that had surgery at least 12 months ago.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Gansevoort Dunnington, MD
role: Principal Investigator
affiliation: St. Helena Hospital Adventist Heart Institute
responsible party type: Sponsor
sharing ipd: No