xml: <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/NCT05997446</url>
    </required_header>
    <id_info>
      <org_study_id>ABT-CIP-10467</org_study_id>
      <secondary_id>CRD_1056</secondary_id>
      <nct_id>NCT05997446</nct_id>
    </id_info>
    <brief_title>Amulet™ ADVANCE LAA</brief_title>
    <official_title>A Real-World Study to Observe Outcomes of Patients Undergoing Closure With the Amplatzer™ Amulet™ Left Atrial Appendage Occluder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Abbott Medical Devices</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Abbott Medical Devices</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective, multicenter, observational study intended to characterize real-world&#xD;
        outcomes on the commercially available Amulet device in the United States. The study will&#xD;
        enroll approximately 1000 subjects at up to 50 US clinical sites. Subjects will be followed&#xD;
        through 24 months in accordance with each site's standard care practices.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The ADVANCE LAA study is intended to characterize real-world outcomes of patients receiving&#xD;
        the commercially available Amulet device in the United States. The Amulet device is intended&#xD;
        to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients&#xD;
        who have nonvalvular atrial fibrillation (NVAF) and who are at increased risk for stroke and&#xD;
        systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short-term&#xD;
        anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic&#xD;
        alternative to oral anticoagulation, taking into consideration the safety and effectiveness&#xD;
        of the device.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 12, 2023</start_date>
    <completion_date type="Anticipated">June 2027</completion_date>
    <primary_completion_date type="Anticipated">June 2027</primary_completion_date>
    <study_type>Observational</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>
    <primary_outcome>
      <measure>Composite endpoint: Death or complications</measure>
      <time_frame>Within 7 days of implant or hospital discharge, whichever is later</time_frame>
      <description>Composite of all-cause death, ischemic stroke, systemic embolism, or device/procedure related complications requiring an invasive surgical or percutaneous intervention within 7 days of implant or hospital discharge, whichever is later</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Device closure, defined as residual jet around the device ≤ 3mm</measure>
      <time_frame>Assessed at first trans-esophageal echocardiogram (TEE) occurring between 30-240 days post-implant.</time_frame>
      <description>Device closure (defined as residual jet around the device ≤ 3mm) at the first follow-up visit documented by trans-esophageal echocardiography (TEE), as assessed by an independent core laboratory</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Composite endpoint: Ischemic stroke or systemic embolism</measure>
      <time_frame>Through 24 months</time_frame>
      <description>Composite of ischemic stroke or systemic embolism through 24 months</description>
    </primary_outcome>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Atrial Fibrillation</condition>
    <condition>Stroke</condition>
    <condition>Bleeding</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Left atrial appendage occlusion (LAAO)</intervention_name>
      <description>Implantation of an Amplatzer Amulet left atrial appendage occluder</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with non-valvular atrial fibrillation who are at increased risk for ischemic&#xD;
          stroke or systemic embolism.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Intended for LAAO with the Amulet device&#xD;
  &#xD;
            -  At least 18 years of age&#xD;
  &#xD;
            -  Willing and capable of providing informed consent and participating in all testing&#xD;
               associated with this clinical study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of other conditions that, in the investigator's opinion, could limit the&#xD;
               subject's ability to participate in follow-up&#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>Kansas City Cardiac Arrhythmia Research Foundation</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>The ADVANCE LAA Study Team</last_name>
      <phone>(651) 756-5400</phone>
      <email>ADVANCE_LAA@abbott.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Arizona Arrhythmia Research</name>
        <address>
          <city>Phoenix</city>
          <state>Arizona</state>
          <zip>85016</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Akash Makkar, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Arrhythmia Research Group</name>
        <address>
          <city>Jonesboro</city>
          <state>Arkansas</state>
          <zip>72401</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <investigator>
        <last_name>Devi Nair, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Arkansas Heart Hospital</name>
        <address>
          <city>Little Rock</city>
          <state>Arkansas</state>
          <zip>72211</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Monica Lo, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Baptist Medical Center</name>
        <address>
          <city>Jacksonville</city>
          <state>Florida</state>
          <zip>32207</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Ruby Satpathy, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Siddharth Wayangankar, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Kansas City Cardiac Arrhythmia Research Foundation</name>
        <address>
          <city>Overland Park</city>
          <state>Kansas</state>
          <zip>66211</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Dhanunjaya Lakkireddy, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Bryan Heart</name>
        <address>
          <city>Lincoln</city>
          <state>Nebraska</state>
          <zip>68506</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <investigator>
        <last_name>Robert Percell, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Brock Cookman, DO</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</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>Atrial Fibrillation</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997446
  org study id: ABT-CIP-10467
  secondary id: CRD_1056
  nct id: NCT05997446
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  This is a prospective, multicenter, observational study intended to characterize real-world
        outcomes on the commercially available Amulet device in the United States. The study will
        enroll approximately 1000 subjects at up to 50 US clinical sites. Subjects will be followed
        through 24 months in accordance with each site's standard care practices.
  The ADVANCE LAA study is intended to characterize real-world outcomes of patients receiving
        the commercially available Amulet device in the United States. The Amulet device is intended
        to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients
        who have nonvalvular atrial fibrillation (NVAF) and who are at increased risk for stroke and
        systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short-term
        anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic
        alternative to oral anticoagulation, taking into consideration the safety and effectiveness
        of the device.
  observational model: Cohort
  time perspective: Prospective
  measure: Composite endpoint: Death or complications
  time frame: Within 7 days of implant or hospital discharge, whichever is later
  description: Composite of all-cause death, ischemic stroke, systemic embolism, or device/procedure related complications requiring an invasive surgical or percutaneous intervention within 7 days of implant or hospital discharge, whichever is later
  measure: Device closure, defined as residual jet around the device ≤ 3mm
  time frame: Assessed at first trans-esophageal echocardiogram (TEE) occurring between 30-240 days post-implant.
  description: Device closure (defined as residual jet around the device ≤ 3mm) at the first follow-up visit documented by trans-esophageal echocardiography (TEE), as assessed by an independent core laboratory
  measure: Composite endpoint: Ischemic stroke or systemic embolism
  time frame: Through 24 months
  description: Composite of ischemic stroke or systemic embolism through 24 months
  intervention type: Device
  intervention name: Left atrial appendage occlusion (LAAO)
  description: Implantation of an Amplatzer Amulet left atrial appendage occluder
  study pop: 
  sampling method: 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: Kansas City Cardiac Arrhythmia Research Foundation
  last name: The ADVANCE LAA Study Team
  phone: (651) 756-5400
  email: ADVANCE_LAA@abbott.com
  facility: 
  status: Not yet recruiting
  investigator: 
  facility: 
  status: Not yet recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  facility: 
  status: Recruiting
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Atrial Fibrillation