<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/NCT04429646</url>
  </required_header>
  <id_info>
    <org_study_id>SAHZJU CT019</org_study_id>
    <nct_id>NCT04429646</nct_id>
  </id_info>
  <brief_title>LAMax Vs. Watchman LAAC Device for Subjects With Non-valvular AF to Reduce the Risk of Stroke</brief_title>
  <official_title>A Prospective, Multicenter, Randomized, Active Controlled, Clinical Trial of the LAMax LAA Closure System Compared to the Watchman® LAAC Device for Subjects With Non-valvular Atrial Fibrillation to Reduce the Risk of Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Third Medical Center, Chinese People's Liberation Army General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ganzhou Municipal Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Guangxi Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Hospital of Hebei Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>LanZhou University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Affiliated Hospital of Nanchang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Nanchang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Municipal hospital of Ningbo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>General Hospital of Tianjin Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>ShenZhen KYD Biomedical Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate&#xD;
      the safety and effectiveness of the LAMax Left Atrial Appendage (LAA) Closure System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate&#xD;
      the safety and effectiveness of the LAMax Left Atrial Appendage Closure (LAAC) System.&#xD;
      Subjects with non-valvular Atrial Fibrillation will be randomized in a 1:1 ratio to the&#xD;
      Experimental Treatment Arm (LAMax LAAC system) or the Control Arm (Watchman LAAC system,&#xD;
      Boston Scientific Inc., USA). The trial is designed to demonstrate that safety and&#xD;
      effectiveness of the LAMax device are non-inferior to the Watchman device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 20, 2019</start_date>
  <completion_date type="Actual">June 10, 2021</completion_date>
  <primary_completion_date type="Actual">November 11, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Prevention Endpoint Classification: Safety/Efficacy Study Masking: Open Label</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Successful sealing of the LAA</measure>
    <time_frame>12 months post-implantation</time_frame>
    <description>A composite rate of successful sealing of the left atrial appendage (defined as residual flow ≤ 5 mm) at the 12-month visit documented by transesophageal echocardiogram (TEE).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ischemic stroke, TIA, or Systemic embolism</measure>
    <time_frame>12 months post-implantation</time_frame>
    <description>A composite rate of ischemic stroke, TIA or systemic embolism.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All stroke, systemic embolism, or cardiovascular/unexplained death</measure>
    <time_frame>12 months post-implantation</time_frame>
    <description>A composite rate of all stroke, systemic embolism, or cardiovascular/unexplained death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of MACCE events</measure>
    <time_frame>12 months post-implantation</time_frame>
    <description>A composite rate of MACCE, includes all-cause mortality, stroke, device embolism, cardiac tamponade.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Bleeding post-device implant</measure>
    <time_frame>12 months post-implantation</time_frame>
    <description>Major bleeding rate at 12 months post-implant: defined as Type 3a or greater based on the Bleeding Academic Research Consortium (BARC) definition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Success rate of device collapse and reposition during implantation procedure</measure>
    <time_frame>0 day</time_frame>
    <description>It is one of the measures to describe device performance during implantation procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of cardiac temponade during implantation procedure</measure>
    <time_frame>0 day</time_frame>
    <description>It is one of the measures to describe the performance of device and delivery system during implantation procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Success rate of delivering an occlusion device to the LAA by the delivery system</measure>
    <time_frame>0 day</time_frame>
    <description>It is one of the measures to describe the performance of delivery system during implantation procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Success rate of withdrawing a delivery system after LAAC</measure>
    <time_frame>0 day</time_frame>
    <description>It is one of the measures to describe the performance of delivery system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device performance post-implantation</measure>
    <time_frame>12 months post-implantation</time_frame>
    <description>A composite rate of device migration, embolization, regurgitation, perivalvular leak post-implantation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device success rate</measure>
    <time_frame>0 day</time_frame>
    <description>A composite rate to describe that the device can be successfully delivered in place and successfully implanted, and angiography shows that the implanted device is in the right position, no residual flow or residual flow is less than 5 mm, and the delivery system can be successfully withdrawn.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perioperative clinical success rate</measure>
    <time_frame>7 days post-implantation</time_frame>
    <description>A composite rate to describe that the device's function is normal, including that it was successfully implanted, the residual flow was less than 5mm, the implanted device had no effect on mitral valve movement and pulmonary vein blood flow, and there was no major adverse event (MAE) at the time of discharge.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">236</enrollment>
  <condition>Non-valvular Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>LAMax left atrial appendage occluder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention device, LAMax left atrial appendage closure system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Watchman (control)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention device, Watchman® LAA Closure Device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Percutaneous left atrial appendage closure-LAMax</intervention_name>
    <description>Interventional device, LAMax left atrial appendage closure system</description>
    <arm_group_label>LAMax left atrial appendage occluder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Percutaneous left atrial appendage closure-Watchman</intervention_name>
    <description>Interventional device, Watchman® LAA Closure Device</description>
    <arm_group_label>Watchman (control)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ≥ 18 years old with non-valvular atrial fibrillation (AF) and CHA2DS2-VASc ≥2&#xD;
&#xD;
          -  There is one of the following: (1) Not suitable for long-term standard anticoagulation&#xD;
             treatment; (2) On the basis of long-term standardized anticoagulant therapy with&#xD;
             warfarin, stroke or embolism still occurred; (3) HAS-BLED ≥ 3.&#xD;
&#xD;
          -  Provide written informed consent and agree to comply with required follow-ups.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. . Patients with other diseases other than AF who need long-term warfarin&#xD;
             anticoagulation therapy;&#xD;
&#xD;
          2. . Those who need selective cardiac surgery;&#xD;
&#xD;
          3. . Heart failure NYHA grade IV;&#xD;
&#xD;
          4. . AF caused by rheumatic valvular disease, degenerative valvular disease, congenital&#xD;
             valvular disease, severe mitral stenosis, aortic stenosis, or other valvular diseases;&#xD;
&#xD;
          5. . The early onset of AF and paroxysmal AF with definite causes, such as secondary to&#xD;
             coronary artery bypass grafting (CABG), hyperthyroidism;&#xD;
&#xD;
          6. . Patients with symptomatic carotid artery disease (such as carotid stenosis &gt; 50%);&#xD;
&#xD;
          7. . Patients with acute myocardial infarction, unstable angina, or recent myocardial&#xD;
             infarction &lt; 3 months;&#xD;
&#xD;
          8. . Stroke or TIA within 30 days;&#xD;
&#xD;
          9. . Bleeding disease, coagulation-related diseases, and active peptic ulcer;&#xD;
&#xD;
         10. . Active endocarditis, vegetations, or other infections causing bacteremia or sepsis;&#xD;
&#xD;
         11. . Conditions may lead to difficulty in testing or significantly shorten the life&#xD;
             expectancy of patients (&lt; 1 year);&#xD;
&#xD;
         12. . Pregnant, lactating or planned pregnancy during the trial;&#xD;
&#xD;
         13. . Patients who have not reached the end of other clinical trials of drug or device;&#xD;
&#xD;
         14. . Hematological abnormality (WBC &lt; 3 × 109 / L, HB &lt; 90g / L, or platelet count &lt; 50 ×&#xD;
             109 / L or &gt; 700 × 109 / L));&#xD;
&#xD;
         15. . Renal insufficiency (creatinine &gt; 3.0mg/dl or 265.2umoi / L), and / or advanced&#xD;
             renal diseases requiring dialysis;&#xD;
&#xD;
         16. . Severe liver dysfunction (AST / ALT is 5 times higher than the upper limit of normal&#xD;
             value, or total bilirubin is 2 times higher than the upper limit of normal value);&#xD;
&#xD;
         17. . The investigator believes that the patient is not suitable to participate in the&#xD;
             clinical trial.&#xD;
&#xD;
         18. . Left atrial appendage has been removed, post heart transplantation, post atrial&#xD;
             septal repair, or post occluder implantation;&#xD;
&#xD;
         19. . Radiofrequency ablation in 30 days before and after the implantation of LAA&#xD;
             occluder;&#xD;
&#xD;
         20. . Cardioversion within 30 days after the implantation of LAA occluder;&#xD;
&#xD;
         21. . Post prosthetic heart valve replacement;&#xD;
&#xD;
         22. . Allergic to or contraindication to metal nickel alloy, aspirin, clopidogrel,&#xD;
             contrast agent, heparin and other anticoagulants, etc;&#xD;
&#xD;
         23. . Patients who have placed other instruments in the cardiovascular cavity and are&#xD;
             unable to place the LAA occluder;&#xD;
&#xD;
         24. . LVEF（left ventricular ejection fraction ）&lt;35%；&#xD;
&#xD;
         25. . Clear thrombus is found in the heart before device implantation;&#xD;
&#xD;
         26. . TEE examination: refer to Watchman LAAC requirement to measure the orifice diameter&#xD;
             of LAA, the maximum diameter is less than 17 mm, or more than 31 mm;&#xD;
&#xD;
         27. . Patent foramen ovale with high risk;&#xD;
&#xD;
         28. . mitral stenosis with a valve area ≤ 2 cm2;&#xD;
&#xD;
         29. . left atrial diameter &gt; 65mm, or pericardial effusion more than a small amount, the&#xD;
             depth of local effusion &gt; 10 mm;&#xD;
&#xD;
         30. . Contraindications to X-ray, or not suitable for TEE examination.&#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>Jian-an Wang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dongxing Ma, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Third Medical Center, Chinese People's Liberation Army General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The First Hospital of Lanzhou University</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <zip>730000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Hebei Medical University</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ganzhou Municipal Hospital</name>
      <address>
        <city>Ganzhou</city>
        <state>Jiangxi</state>
        <zip>341001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital, School of Medicine, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Municipal hospital of Ningbo</name>
      <address>
        <city>Ningbo</city>
        <state>Zhejiang</state>
        <zip>315010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Medical Center, Chinese People's Liberation Army General Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100039</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <zip>400010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <zip>200011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Tianjin Medical University</name>
      <address>
        <city>Tianjin</city>
        <zip>300020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>May 4, 2022</last_update_submitted>
  <last_update_submitted_qc>May 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</investigator_affiliation>
    <investigator_full_name>Jian'an Wang,MD,PhD</investigator_full_name>
    <investigator_title>President of the Second Affiliated Hospital, School of Medicine, Zhejiang University &amp; Chief of Cardiology</investigator_title>
  </responsible_party>
  <keyword>Atrial Fibrillation</keyword>
  <keyword>Left Atrial Appendage Closure</keyword>
  <keyword>Ischemic Stroke</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/NCT04429646
org study id: SAHZJU CT019
nct id: NCT04429646
lead sponsor: 
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is fda regulated drug: No
is fda regulated device: No
This is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate
      the safety and effectiveness of the LAMax Left Atrial Appendage (LAA) Closure System.
This is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate
      the safety and effectiveness of the LAMax Left Atrial Appendage Closure (LAAC) System.
      Subjects with non-valvular Atrial Fibrillation will be randomized in a 1:1 ratio to the
      Experimental Treatment Arm (LAMax LAAC system) or the Control Arm (Watchman LAAC system,
      Boston Scientific Inc., USA). The trial is designed to demonstrate that safety and
      effectiveness of the LAMax device are non-inferior to the Watchman device.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Prevention Endpoint Classification: Safety/Efficacy Study Masking: Open Label
primary purpose: Prevention
masking: None (Open Label)
measure: Successful sealing of the LAA
time frame: 12 months post-implantation
description: A composite rate of successful sealing of the left atrial appendage (defined as residual flow ≤ 5 mm) at the 12-month visit documented by transesophageal echocardiogram (TEE).
measure: Ischemic stroke, TIA, or Systemic embolism
time frame: 12 months post-implantation
description: A composite rate of ischemic stroke, TIA or systemic embolism.
measure: All stroke, systemic embolism, or cardiovascular/unexplained death
time frame: 12 months post-implantation
description: A composite rate of all stroke, systemic embolism, or cardiovascular/unexplained death.
measure: Incidence of MACCE events
time frame: 12 months post-implantation
description: A composite rate of MACCE, includes all-cause mortality, stroke, device embolism, cardiac tamponade.
measure: Major Bleeding post-device implant
time frame: 12 months post-implantation
description: Major bleeding rate at 12 months post-implant: defined as Type 3a or greater based on the Bleeding Academic Research Consortium (BARC) definition.
measure: Success rate of device collapse and reposition during implantation procedure
time frame: 0 day
description: It is one of the measures to describe device performance during implantation procedure.
measure: Rate of cardiac temponade during implantation procedure
time frame: 0 day
description: It is one of the measures to describe the performance of device and delivery system during implantation procedure.
measure: Success rate of delivering an occlusion device to the LAA by the delivery system
time frame: 0 day
description: It is one of the measures to describe the performance of delivery system during implantation procedure.
measure: Success rate of withdrawing a delivery system after LAAC
time frame: 0 day
description: It is one of the measures to describe the performance of delivery system.
measure: Device performance post-implantation
time frame: 12 months post-implantation
description: A composite rate of device migration, embolization, regurgitation, perivalvular leak post-implantation.
measure: Device success rate
time frame: 0 day
description: A composite rate to describe that the device can be successfully delivered in place and successfully implanted, and angiography shows that the implanted device is in the right position, no residual flow or residual flow is less than 5 mm, and the delivery system can be successfully withdrawn.
measure: Perioperative clinical success rate
time frame: 7 days post-implantation
description: A composite rate to describe that the device's function is normal, including that it was successfully implanted, the residual flow was less than 5mm, the implanted device had no effect on mitral valve movement and pulmonary vein blood flow, and there was no major adverse event (MAE) at the time of discharge.
arm group label: LAMax left atrial appendage occluder
arm group type: Experimental
description: Intervention device, LAMax left atrial appendage closure system
arm group label: Watchman (control)
arm group type: Active Comparator
description: Intervention device, Watchman® LAA Closure Device
intervention type: Device
intervention name: Percutaneous left atrial appendage closure-LAMax
description: Interventional device, LAMax left atrial appendage closure system
arm group label: LAMax left atrial appendage occluder
intervention type: Device
intervention name: Percutaneous left atrial appendage closure-Watchman
description: Interventional device, Watchman® LAA Closure Device
arm group label: Watchman (control)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jian-an Wang, MD, PhD
role: Principal Investigator
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
last name: Dongxing Ma, MD
role: Principal Investigator
affiliation: The Third Medical Center, Chinese People's Liberation Army General Hospital
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country: China
responsible party type: Principal Investigator
investigator affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
investigator full name: Jian'an Wang,MD,PhD
investigator title: President of the Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology
mesh term: Atrial Fibrillation