<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/NCT01695564</url>
  </required_header>
  <id_info>
    <org_study_id>13240</org_study_id>
    <nct_id>NCT01695564</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Left Atrial Appendage Occlusion Devices</brief_title>
  <official_title>Comparison of Safety and Efficacy of Left Atrial Appendage Occlusion Devices</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kansas City Heart Rhythm Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kansas City Heart Rhythm Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Atrial fibrillation (AF) is the most common cardiac rhythm disorder in clinical practice. In&#xD;
      the last two decades the number of hospitalizations for AF has increased two- to three-fold.&#xD;
      More than 6 million people worldwide suffer from atrial fibrillation (AF), a cardiac disorder&#xD;
      that results in systemic emboli. Patients with AF are 5 times more likely to have a stroke&#xD;
      compared with those without AF.&#xD;
&#xD;
      This registry will collection information on two devices that are used to treat AF. The&#xD;
      WATCHMAN and LARIAT. The differences in techniques and subsequent effects of the two devices&#xD;
      on outcomes related to AF has not been studied. This study will look to compare the two&#xD;
      devices to see how the outcomes may vary.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of LAA occlusion by LARIAT device</measure>
    <time_frame>Change from Day 0 to Day 90</time_frame>
    <description>This registry will provide data on patient outcomes at different times during follow up. This includes: changes in the appendage size, shape and patients medical history.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of LAA occlusion by LARIAT device</measure>
    <time_frame>Change from Day 0 to 356 post-procedure</time_frame>
    <description>This registry will provide data on patient outcomes at different times during follow up.This includes: changes in the appendage size, shape and patients medical history.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare effectiveness of LAA occlusion procedure by evaluating LAA jet velocities</measure>
    <time_frame>Days 0, 90, 180, 365 post-procedure and annually thereafter</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">169</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>WATCHMAN</arm_group_label>
    <description>Patients that had the WATCHMAN device implanted</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LARIAT LAA Device</arm_group_label>
    <description>patients that had LARIAT LAA device implanted</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LARIAT LAA</intervention_name>
    <description>The LARIAT snare device is an over-the-wire device guided over the LAA to enable ligation of the LAA. The LARIAT can be opened and closed as desired for ideal positioning without risk of suture deployment.</description>
    <arm_group_label>LARIAT LAA Device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WATCHMAN</intervention_name>
    <description>The WATCHMAN is an expandable device deployed in the LAA via a trans-septal catheter. The implanted device has a self-expanding nitinol frame to secure it in the LAA. The fabric of the WATCHMAN device is permeable to blood.</description>
    <arm_group_label>WATCHMAN</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have had a LARIAT LAA device occlusion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have had a LARIAT LAA device occlusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have PFO/ASD/critical carotid artery (&gt;70% blockage) disease and&#xD;
             hemorrhagic strokes&#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>Dhanunjaya Lakkireddy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>April 30, 2019</last_update_submitted>
  <last_update_submitted_qc>April 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>atrial enlargement</keyword>
  <keyword>left atrial appendage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</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/NCT01695564
org study id: 13240
nct id: NCT01695564
lead sponsor: 
has dmc: No
Atrial fibrillation (AF) is the most common cardiac rhythm disorder in clinical practice. In
      the last two decades the number of hospitalizations for AF has increased two- to three-fold.
      More than 6 million people worldwide suffer from atrial fibrillation (AF), a cardiac disorder
      that results in systemic emboli. Patients with AF are 5 times more likely to have a stroke
      compared with those without AF.

      This registry will collection information on two devices that are used to treat AF. The
      WATCHMAN and LARIAT. The differences in techniques and subsequent effects of the two devices
      on outcomes related to AF has not been studied. This study will look to compare the two
      devices to see how the outcomes may vary.
observational model: Case-Control
time perspective: Retrospective
measure: Effect of LAA occlusion by LARIAT device
time frame: Change from Day 0 to Day 90
description: This registry will provide data on patient outcomes at different times during follow up. This includes: changes in the appendage size, shape and patients medical history.
measure: Effect of LAA occlusion by LARIAT device
time frame: Change from Day 0 to 356 post-procedure
description: This registry will provide data on patient outcomes at different times during follow up.This includes: changes in the appendage size, shape and patients medical history.
measure: Compare effectiveness of LAA occlusion procedure by evaluating LAA jet velocities
time frame: Days 0, 90, 180, 365 post-procedure and annually thereafter
arm group label: WATCHMAN
description: Patients that had the WATCHMAN device implanted
arm group label: LARIAT LAA Device
description: patients that had LARIAT LAA device implanted
intervention type: Device
intervention name: LARIAT LAA
description: The LARIAT snare device is an over-the-wire device guided over the LAA to enable ligation of the LAA. The LARIAT can be opened and closed as desired for ideal positioning without risk of suture deployment.
arm group label: LARIAT LAA Device
intervention type: Device
intervention name: WATCHMAN
description: The WATCHMAN is an expandable device deployed in the LAA via a trans-septal catheter. The implanted device has a self-expanding nitinol frame to secure it in the LAA. The fabric of the WATCHMAN device is permeable to blood.
arm group label: WATCHMAN
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dhanunjaya Lakkireddy, MD
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation