<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/NCT01680757</url>
  </required_header>
  <id_info>
    <org_study_id>RS-001 PLACE III</org_study_id>
    <nct_id>NCT01680757</nct_id>
  </id_info>
  <brief_title>Study of Left Atrial Appendage Closure in Patients With Atrial Fibrillation - III</brief_title>
  <acronym>PLACE III</acronym>
  <official_title>Multicenter Registry of Permanent Ligation Approximation Closure Exclusion of the Left Atrial Appendage in Patients With Atrial Fibrillation III (PLACE III)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AtriCure, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective, multicenter, non-randomized trial of a stand-alone procedure for&#xD;
      left atrial appendage exclusion in patients with atrial fibrillation at risk for embolic&#xD;
      events who are contraindicated for or intolerant of oral anticoagulation therapy. This study&#xD;
      will enroll 100 participant, who will receive the LAA ligation study treatment. The objective&#xD;
      of this registry is to assess the effectiveness of permanent exclusion of the LAA using the&#xD;
      LARIAT Suture Delivery Device and Accessories in patients unable to be treated with standard&#xD;
      anticoagulation therapy. The results of the study will be used to assess outcomes within the&#xD;
      first year, post-treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    This study has been withdrawn prior to enrollment&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">March 2014</completion_date>
  <primary_completion_date type="Anticipated">March 2014</primary_completion_date>
  <phase>Phase 4</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of complete exclusion</measure>
    <time_frame>During 1 year follow-up.</time_frame>
    <description>To assess the rate of complete exclusion of the left atrial appendage (defined as &lt; 1 mm of communication between left appendage and atrium) measured by color duplex transesophageal echocardiography TEE).</description>
  </primary_outcome>
  <other_outcome>
    <measure>Rate of procedural success</measure>
    <time_frame>Baseline</time_frame>
    <description>Exploratory objectives include assessment of the rate of procedural success (defined as completion of the procedure as intended at baseline, as assessed by the clinical site Principal Investigator)</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of complications</measure>
    <time_frame>During 1 year follow-up</time_frame>
    <description>Exploratory objectives include assessment of the rate of complications related to the use of the LARIAT and accessories</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>LAA exclusion with LARIAT &amp; Accessories</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Permanent exclusion of the LAA using the LARIAT Suture Delivery Device and Accessories</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LARIAT Suture Delivery Device and Accessories</intervention_name>
    <arm_group_label>LAA exclusion with LARIAT &amp; Accessories</arm_group_label>
    <other_name>LARIATTM Suture Delivery Device</other_name>
    <other_name>ENDOCATH Occlusion Balloon</other_name>
    <other_name>SOFTIPTM Guide Cannula</other_name>
    <other_name>FINDRWIRZ Guide Wire System</other_name>
    <other_name>SURECUT Suture Cutter</other_name>
    <other_name>TENSURE Suture Puller</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged ≥ 21 years&#xD;
&#xD;
          2. Diagnosed non-valvular atrial fibrillation&#xD;
&#xD;
          3. Current CHADS2 score &gt; 2&#xD;
&#xD;
          4. Currently contraindicated to or intolerant of standard anticoagulation therapy (i.e.,&#xD;
             warfarin, dabigatran, apixaban, and rivaroxaban) due to at least one of the following:&#xD;
             history of bleeding or high risk of bleeding; labile INR level (While on&#xD;
             anticoagulation therapy, participant had INR results &quot;out of therapeutic range&quot; &gt; 40%&#xD;
             of the time, over a minimum period of 2 months.); non-compliant, unwilling to take, or&#xD;
             anticoagulant failure (e.g., TIA or stroke while on anticoagulant therapy).&#xD;
&#xD;
          5. Life expectancy of at least 1 year&#xD;
&#xD;
          6. Willing and able to return and comply with scheduled follow up visits&#xD;
&#xD;
          7. Willing and able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior cardiac surgery involving opening of pericardium (e.g., CABG, heart&#xD;
             transplantation, valve surgery)&#xD;
&#xD;
          2. Prosthetic heart valve or ring in any position&#xD;
&#xD;
          3. Current NYHA Class IV heart failure symptoms&#xD;
&#xD;
          4. Current right heart failure&#xD;
&#xD;
          5. Myocardial infarction within last 3 months&#xD;
&#xD;
          6. Unstable angina within last 3 months&#xD;
&#xD;
          7. Current cardiogenic shock or hemodynamic instability&#xD;
&#xD;
          8. Current symptomatic carotid disease&#xD;
&#xD;
          9. Need for an intra-aortic balloon pump or intravenous inotropes&#xD;
&#xD;
         10. Embolic stroke within the last 30 days&#xD;
&#xD;
         11. Transient ischemic attack (TIA) within the last 30 days&#xD;
&#xD;
         12. Current diagnosis of active systemic infection&#xD;
&#xD;
         13. eGFR &lt; 60 mL/min/1.73m2 within last 3 months&#xD;
&#xD;
         14. Current renal failure requiring dialysis&#xD;
&#xD;
         15. ALT or AST level &gt; 3 times upper level of normal, indicating hepatic failure. (NOTE:&#xD;
             normal range provided by local laboratory performing the measurement), based on most&#xD;
             recent pre-procedure assessment (within 30 days of study treatment)&#xD;
&#xD;
         16. Current clinical evidence of cirrhosis&#xD;
&#xD;
         17. Any history of thoracic radiation&#xD;
&#xD;
         18. Current use of long term treatment with steroids, not including intermittent use of&#xD;
             inhaled steroids for respiratory diseases&#xD;
&#xD;
         19. Diagnosed autoimmune disease known to be associated with pericarditis (i.e., specific&#xD;
             connective tissue disorders)&#xD;
&#xD;
         20. Any history of pericarditis&#xD;
&#xD;
         21. Pectus excavatum (clinically defined by treating physician)&#xD;
&#xD;
         22. Severe scoliosis&#xD;
&#xD;
         23. Thrombocytopenia (platelet count &lt; 100 x 109/L) based on most recent pre-procedure&#xD;
             assessment (within 30 days of study treatment)&#xD;
&#xD;
         24. Anemia with hemoglobin concentration of &lt; 10 g/dL based on most recent pre-procedure&#xD;
             assessment (within 30 days of study treatment)&#xD;
&#xD;
         25. Pregnancy or desire to get pregnant within next 12 months.&#xD;
&#xD;
         26. Current enrollment in an investigation or study of a cardiovascular device or&#xD;
             investigational drug that would interfere with this registry&#xD;
&#xD;
         27. Mental impairment or other conditions, which may not allow patient to understand the&#xD;
             nature, significance and scope of the study&#xD;
&#xD;
         28. Any other criteria, which would make the patient unsuitable to participate in this&#xD;
             study as determined by clinical site Principal Investigator (e.g., an uncontrolled&#xD;
             drug and/or alcohol addiction)&#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>Gregory Marcus, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner Good Samaritan</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scripps Green Hospital and Clinic</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Hospital of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33176</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Hospital and Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Cardiac Arrhythmia Research Foundation</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Heart Institute</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Methodist Hospital Research Institute</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Center Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <zip>60327</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Paul II Hospital</name>
      <address>
        <city>Krakow</city>
        <zip>31202</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Poland</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>February 21, 2013</last_update_submitted>
  <last_update_submitted_qc>February 21, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 25, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Left Atrial Appendage</keyword>
  <keyword>LARIAT</keyword>
  <keyword>atrial fibrillation</keyword>
  <keyword>contraindication to oral anticoagulation therapy</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/NCT01680757
org study id: RS-001 PLACE III
nct id: NCT01680757
lead sponsor: 
collaborator: 
has dmc: No
This study is a prospective, multicenter, non-randomized trial of a stand-alone procedure for
      left atrial appendage exclusion in patients with atrial fibrillation at risk for embolic
      events who are contraindicated for or intolerant of oral anticoagulation therapy. This study
      will enroll 100 participant, who will receive the LAA ligation study treatment. The objective
      of this registry is to assess the effectiveness of permanent exclusion of the LAA using the
      LARIAT Suture Delivery Device and Accessories in patients unable to be treated with standard
      anticoagulation therapy. The results of the study will be used to assess outcomes within the
      first year, post-treatment.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Rate of complete exclusion
time frame: During 1 year follow-up.
description: To assess the rate of complete exclusion of the left atrial appendage (defined as < 1 mm of communication between left appendage and atrium) measured by color duplex transesophageal echocardiography TEE).
measure: Rate of procedural success
time frame: Baseline
description: Exploratory objectives include assessment of the rate of procedural success (defined as completion of the procedure as intended at baseline, as assessed by the clinical site Principal Investigator)
measure: Rate of complications
time frame: During 1 year follow-up
description: Exploratory objectives include assessment of the rate of complications related to the use of the LARIAT and accessories
arm group label: LAA exclusion with LARIAT & Accessories
arm group type: Experimental
description: Permanent exclusion of the LAA using the LARIAT Suture Delivery Device and Accessories
intervention type: Device
intervention name: LARIAT Suture Delivery Device and Accessories
arm group label: LAA exclusion with LARIAT & Accessories
other name: LARIATTM Suture Delivery Device
other name: ENDOCATH Occlusion Balloon
other name: SOFTIPTM Guide Cannula
other name: FINDRWIRZ Guide Wire System
other name: SURECUT Suture Cutter
other name: TENSURE Suture Puller
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Gregory Marcus, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Poland
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation