<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/NCT04468334</url>
  </required_header>
  <id_info>
    <org_study_id>RS-011, Appendix 16</org_study_id>
    <nct_id>NCT04468334</nct_id>
  </id_info>
  <brief_title>aMAZE Trial Continued Access Protocol</brief_title>
  <acronym>aMAZE CAP</acronym>
  <official_title>Non-randomized, Multicenter Expanded Use Evaluation of the LARIAT® Suture Delivery Device (Appendix 16 to Ongoing Investigation)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AtriCure, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AtriCure, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      aMAZE CAP is an extension to the current aMAZE Trial investigation&#xD;
      (IDEG150107/NCT02517397/Protocol Appendix 16) in the form of a nested, non-randomized&#xD;
      registry, to allow ongoing treatment of subjects and the collection of additional safety and&#xD;
      effectiveness data at existing aMAZE investigational sites.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For consistency, aMAZE CAP primary and secondary safety and efficacy endpoints, eligibility&#xD;
      criteria and follow up visit assessments remain unchanged from the current aMAZE Trial&#xD;
      investigation (NCT02517397).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 9, 2020</start_date>
  <completion_date type="Anticipated">March 2025</completion_date>
  <primary_completion_date type="Anticipated">July 2023</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Freedom from episodes of atrial fibrillation &gt; 30 seconds at 12 months post index pulmonary vein isolation</measure>
    <time_frame>12 months following Pulmonary Vein Isolation catheter ablation procedure</time_frame>
    <description>Measured by 24-hour Holter Monitoring</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Freedom from any atrial fibrillation/atrial tachycardia/atrial flutter recurrence defined as any episode &gt; 30 seconds with or without AAD</measure>
    <time_frame>Following the 90 day blanking period through 12 months post-index pulmonary vein isolation</time_frame>
    <description>Measured by 24-hour Holter Monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite endpoint of stroke of any cause and systemic embolism as adjudicated by the clinical events committee</measure>
    <time_frame>12 months following index pulmonary vein isolation</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>LARIAT Technical Success</measure>
    <time_frame>Immediately post-LARIAT ligation (acute) and at 12 months following index pulmonary vein isolation</time_frame>
    <description>Successful placement of the LARIAT device pre-tied suture around the left atrial appendage to achieve left atrial appendage ligation defined as ≤1 ± 1mm diameter residual communication w/ left atrium, as assessed by transesophageal echocardiography</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">85</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>LARIAT + PVI Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Percutaneously isolate and ligate the Left Atrial Appendage (LAA) from the left atrium (LA) with the LARIAT System prior to planned pulmonary vein isolation (PVI) catheter ablation&#xD;
Subgroup 1: Radiofrequency (RF) PVI catheter ablation treatment (n&lt;65) Subgroup 2: Cryoballoon PVI catheter ablation treatment (n&lt;20)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LARIAT + PVI</intervention_name>
    <description>LAA ligation with the LARIAT System initially performed followed by adjunctive PVI catheter ablation (RF or cryoballoon) in staged procedures</description>
    <arm_group_label>LARIAT + PVI Treatment Group</arm_group_label>
    <other_name>LAA + RF PVI</other_name>
    <other_name>LAA + Cryo PVI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented diagnosis of symptomatic continuous persistent or longstanding persistent&#xD;
             non-valvular atrial fibrillation&#xD;
&#xD;
          -  Failed at least one Class I or III Antiarrythmic drug (AAD) and therefore, eligible&#xD;
             and intended for standard of care catheter ablation;&#xD;
&#xD;
          -  Life expectancy ≥ 1 year;&#xD;
&#xD;
          -  Willing and able to return to and comply with scheduled follow-up visits and tests;&#xD;
             and&#xD;
&#xD;
          -  Willing and able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior procedure involving opening of the pericardium or entering the pericardial space&#xD;
             (e.g., coronary artery bypass graft, heart transplantation, valve surgery) where&#xD;
             adhesions are suspected;&#xD;
&#xD;
          -  Any prior epicardial ablation or any type of left-sided atrial ablation procedure;&#xD;
&#xD;
          -  LA diameter &gt; 6 cm as measured by computerized tomography and confirmed by the imaging&#xD;
             core laboratory;&#xD;
&#xD;
          -  Documented embolic stroke, transient ischemic attach or suspected neurologic event&#xD;
             within 3 months prior to the planned study intervention;&#xD;
&#xD;
          -  Currently exhibits New York Heart Association Class IV heart failure symptoms;&#xD;
&#xD;
          -  Documented history of right heart failure specifically when right ventricle exceeds&#xD;
             the left ventricular size;&#xD;
&#xD;
          -  Documented history of myocardial infarction (MI) within 3 months prior to the planned&#xD;
             study intervention;&#xD;
&#xD;
          -  Documented history of unstable angina within 3 months prior to the planned study&#xD;
             intervention;&#xD;
&#xD;
          -  Documented history of cardiogenic shock, hemodynamic instability or any medical&#xD;
             condition in which intra-aortic balloon pump (IABP) therapy is clinically indicated&#xD;
             within 3 months prior to the planned study intervention;&#xD;
&#xD;
          -  Documented symptomatic carotid disease, defined as &gt; 70% stenosis or &gt; 50% stenosis&#xD;
             with symptoms;&#xD;
&#xD;
          -  Diagnosed active local or systemic infection, septicemia or fever of unknown origin at&#xD;
             tme of baseline screening;&#xD;
&#xD;
          -  Chronic renal insufficiency defined as eGFR &lt; 30 mL/min/1.73m2 within 3 months prior&#xD;
             to planned study intervention;&#xD;
&#xD;
          -  End Stage Renal Disease (ESRD) or documented history of renal replacement / dialysis;&#xD;
&#xD;
          -  Current documented history of clinically significant liver disease which predisposes&#xD;
             the subject to significant bleeding risk (clinically defined by the treating&#xD;
             physician);&#xD;
&#xD;
          -  Any history of thoracic radiation with the exception of localized radiation treatment&#xD;
             for breast cancer;&#xD;
&#xD;
          -  Current documented use of long-term treatment with oral corticoid steroids, not&#xD;
             including use of inhaled steroids for respiratory diseases;&#xD;
&#xD;
          -  Active pericarditis;&#xD;
&#xD;
          -  Active endocarditis;&#xD;
&#xD;
          -  Any documented history or autoimmune disease associated with pericarditis;&#xD;
&#xD;
          -  Evidence of Pectus Excavatum (documented and clinically defined by the treating&#xD;
             physician);&#xD;
&#xD;
          -  Untreated severe scoliosis (documented and clinically defined by treating physician);&#xD;
&#xD;
          -  Documented Left Ventricular Ejection Fraction (LVEF) &lt; 30% within 30 days prior to&#xD;
             planned intervention;&#xD;
&#xD;
          -  Documented presence of implanted congenital defect closure devices, (e.g., atrial&#xD;
             septal defect, patent foramen ovale or ventricular septal defect device);&#xD;
&#xD;
          -  Previously attempted occlusion of the left atrial appendage (by any surgical or&#xD;
             percutaneous method);&#xD;
&#xD;
          -  Inability, or unwillingness or contraindication to undergo TEE or CTA imaging or&#xD;
             24-hour Holter monitoring;&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt; 40;&#xD;
&#xD;
          -  Evidence of active Graves disease;&#xD;
&#xD;
          -  Current untreated hypothyroidism;&#xD;
&#xD;
          -  Any contraindication to suture, endovascular device, or other minimally invasive&#xD;
             techniques including percutaneous, transseptal, and/or sub-xiphoid access;&#xD;
&#xD;
          -  Subject is pregnant or plans / desires to get pregnant within next 12 months;&#xD;
&#xD;
          -  Current enrollment in an investigation or study of an investigational device or&#xD;
             investigational drug that would interfere with this study and the required follow up;&#xD;
&#xD;
          -  Mental impairment or other psychiatric conditions which may not allow patient to&#xD;
             understand the nature, significance and scope of the study;&#xD;
&#xD;
          -  Any other criteria, medical illness or comorbidity which would make the subject&#xD;
             unsuitable to participate in this study as determined by the clinical site Primary&#xD;
             Investigator;&#xD;
&#xD;
        Additional Exclusion Criteria: Based on Screening / Pre-procedure Imaging&#xD;
&#xD;
        Subjects will also be excluded if they meet any of the following:&#xD;
&#xD;
        Based on screening computed tomography angiography performed within 90 days prior to study&#xD;
        intervention as confirmed by the core lab:&#xD;
&#xD;
        Left atrial appendage morphology: Superior-posterior oriented left atrial appendage (i.e.&#xD;
        superior C shape), that has Left atrial appendage distal apex extending posterior to the&#xD;
        ostium of the appendage.&#xD;
&#xD;
        Left atrial appendage positioned behind the pulmonary artery; or All other left atrial&#xD;
        morphology: Left atrial appendage LARIAT approach width &gt; 50 mm.&#xD;
&#xD;
        Based on a peri-procedural imaging (transesophageal echocardiography) at time of LARIAT or&#xD;
        catheter ablation) and confirmed by institution's designated LARIAT echocardiographer:&#xD;
&#xD;
        Intracardiac thrombus; or Significant mitral valve stenosis (i.e., mitral valve stenosis &lt;&#xD;
        1.5cm2)&#xD;
&#xD;
        NOTE: It is anticipated that a majority of subjects enrolled in the aMAZE CAP Trial will be&#xD;
        elderly US Medicare beneficiaries. Therefore, the results from the aMAZE CAP Trial are&#xD;
        expected to be generalizable to the Medicare population&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David J Wilber, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loyola University Department of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dhanunjaya Lakkireddy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kansas City Cardiac Arrhythmia Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent's HealthCare</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University / Bluhm Cardiovascular Institute</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola University Center for Heart and Vascular Medicine</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advocate Christ Medical Center</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prairie Education and Research Cooperative</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62769</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Medicine Central DuPage Hospital</name>
      <address>
        <city>Winfield</city>
        <state>Illinois</state>
        <zip>60190</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Heart Center</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center Research Institute</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas City Cardiac Arrhythmia Research</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Institute of the South Clinical Research Corporation</name>
      <address>
        <city>Houma</city>
        <state>Louisiana</state>
        <zip>70360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UP Health System- Marquette</name>
      <address>
        <city>Marquette</city>
        <state>Michigan</state>
        <zip>49855</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Valley Hospital</name>
      <address>
        <city>Ridgewood</city>
        <state>New Jersey</state>
        <zip>07450</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Mexico Heart Institute</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Oregon Cardiology</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bryn Mawr Medical Specialists Association / Bryn Mawr Hospital</name>
      <address>
        <city>Bryn Mawr</city>
        <state>Pennsylvania</state>
        <zip>19010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</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>Baylor - St. Luke's Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Sacred Heart Medical Center</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Lee RJ, Lakkireddy D, Mittal S, Ellis C, Connor JT, Saville BR, Wilber D. Percutaneous alternative to the Maze procedure for the treatment of persistent or long-standing persistent atrial fibrillation (aMAZE trial): Rationale and design. Am Heart J. 2015 Dec;170(6):1184-94. doi: 10.1016/j.ahj.2015.09.019. Epub 2015 Oct 3.</citation>
    <PMID>26678640</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04468334
org study id: RS-011, Appendix 16
nct id: NCT04468334
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
aMAZE CAP is an extension to the current aMAZE Trial investigation
      (IDEG150107/NCT02517397/Protocol Appendix 16) in the form of a nested, non-randomized
      registry, to allow ongoing treatment of subjects and the collection of additional safety and
      effectiveness data at existing aMAZE investigational sites.
For consistency, aMAZE CAP primary and secondary safety and efficacy endpoints, eligibility
      criteria and follow up visit assessments remain unchanged from the current aMAZE Trial
      investigation (NCT02517397).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Freedom from episodes of atrial fibrillation > 30 seconds at 12 months post index pulmonary vein isolation
time frame: 12 months following Pulmonary Vein Isolation catheter ablation procedure
description: Measured by 24-hour Holter Monitoring
measure: Freedom from any atrial fibrillation/atrial tachycardia/atrial flutter recurrence defined as any episode > 30 seconds with or without AAD
time frame: Following the 90 day blanking period through 12 months post-index pulmonary vein isolation
description: Measured by 24-hour Holter Monitoring
measure: Composite endpoint of stroke of any cause and systemic embolism as adjudicated by the clinical events committee
time frame: 12 months following index pulmonary vein isolation
measure: LARIAT Technical Success
time frame: Immediately post-LARIAT ligation (acute) and at 12 months following index pulmonary vein isolation
description: Successful placement of the LARIAT device pre-tied suture around the left atrial appendage to achieve left atrial appendage ligation defined as ≤1 ± 1mm diameter residual communication w/ left atrium, as assessed by transesophageal echocardiography
arm group label: LARIAT + PVI Treatment Group
arm group type: Experimental
description: Percutaneously isolate and ligate the Left Atrial Appendage (LAA) from the left atrium (LA) with the LARIAT System prior to planned pulmonary vein isolation (PVI) catheter ablation
Subgroup 1: Radiofrequency (RF) PVI catheter ablation treatment (n<65) Subgroup 2: Cryoballoon PVI catheter ablation treatment (n<20)
intervention type: Device
intervention name: LARIAT + PVI
description: LAA ligation with the LARIAT System initially performed followed by adjunctive PVI catheter ablation (RF or cryoballoon) in staged procedures
arm group label: LARIAT + PVI Treatment Group
other name: LAA + RF PVI
other name: LAA + Cryo PVI
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: David J Wilber, MD
role: Principal Investigator
affiliation: Loyola University Department of Medicine
last name: Dhanunjaya Lakkireddy, MD
role: Principal Investigator
affiliation: Kansas City Cardiac Arrhythmia Research
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Lee RJ, Lakkireddy D, Mittal S, Ellis C, Connor JT, Saville BR, Wilber D. Percutaneous alternative to the Maze procedure for the treatment of persistent or long-standing persistent atrial fibrillation (aMAZE trial): Rationale and design. Am Heart J. 2015 Dec;170(6):1184-94. doi: 10.1016/j.ahj.2015.09.019. Epub 2015 Oct 3.
PMID: 26678640
responsible party type: Sponsor
mesh term: Atrial Fibrillation