<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/NCT04479722</url>
  </required_header>
  <id_info>
    <org_study_id>SAFE-PROTECT</org_study_id>
    <nct_id>NCT04479722</nct_id>
  </id_info>
  <brief_title>Using Left Atrium Appendage Closure in NVAF Patients With High Risk of Ischemic Stroke</brief_title>
  <acronym>SAFE-PROTECT</acronym>
  <official_title>Safety And EFficacy of Using LEft Atrium APpendage Closure in Nonvalvular AtRial FibrillatiOn PatienTs With High Risk of ischEmiC sTroke -- A Prospective Multicenter Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai MicroPort Medical (Group) Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai MicroPort Medical (Group) Co., Ltd.</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>
      To evaluate the safety and efficacy of using Microport CardioAdvance Left Atrium Appendage&#xD;
      Closure for preventing stroke in Non-valvular atrial fibrillation (NVAF) patients who have&#xD;
      contraindications for long-term anti-coagulation. And to support registration approval from&#xD;
      National Medical Products Administration (NMPA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SAFE-PROTECT trial is composed of Roll-in group, small-size group and RCT group. This trial&#xD;
      is planned to conduct in about 20 sites from China.&#xD;
&#xD;
      Roll-in group plans to enroll at most 3 subjects each site to implant experimental device for&#xD;
      exploration and observation.&#xD;
&#xD;
      RCT group plans to enroll no less than 210 subjects who meet the inclusion/exclusion&#xD;
      criteria, and 1:1 randomly allocated to experimental arm or comparator arm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">December 31, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical success</measure>
    <time_frame>12-month</time_frame>
    <description>Freedom from ischemic stroke, hemorrhagic stroke, systemic embolism, cardiovascular death and unexplained death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>LAA occlusion success</measure>
    <time_frame>12-month</time_frame>
    <description>TEE examination showing that the residual shunt &lt; 5mm jet width or complete occlusion of LAA</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">210</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Microport CardioAdvance LAAC system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject implant Microport CardioAdvance LAAC system to occlude LAA through percutaneous intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Watchman LAAC system</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subject implant Watchman LAAC system to occlude LAA through percutaneous intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Left atrial appendage closure procedure</intervention_name>
    <description>Implant LAAC system in LAA through percutaneous intervention</description>
    <arm_group_label>Microport CardioAdvance LAAC system</arm_group_label>
    <arm_group_label>Watchman LAAC system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non valvular atrial fibrillation subjects aged ≥18 and ≤80;&#xD;
&#xD;
          -  High risk of ischemic stroke: CHA2DS2VASc score ≥ 2 ( ≥ 3 for female) together with&#xD;
             any of the following circumstances:&#xD;
&#xD;
               1. With a recorded history (happened earlier than 6 months from now) of bleeding&#xD;
                  (including gingival/nasal/oral bleeding, skin &amp;soft tissue bleeding,&#xD;
                  gastrointestinal bleeding, urinary tract bleeding, cerebral haemorrhage, etc.) or&#xD;
                  bleeding tendency;&#xD;
&#xD;
               2. Intolerance or rejection of long-term anti-coagulation therapy;&#xD;
&#xD;
               3. Suffering stroke or embolism despite routine anti-coagulation therapy;&#xD;
&#xD;
               4. With a predicting HAS-BLED score ≥3.&#xD;
&#xD;
          -  Subjects (or his/her legal representatives) are able to understand the study&#xD;
             objectives, willing to cooperate with procedure and follow-up. Subjects who&#xD;
             voluntarily participate in this trial and have signed the written informed consent&#xD;
             form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with atrial fibrillation (AF) caused by rheumatic valvular disease, moderate&#xD;
             to severe mitral stenosis, severe mitral regurgitation, severe aortic valve disease or&#xD;
             severe left ventricular outflow tract obstruction with pressure difference greater&#xD;
             than 40mmHg;&#xD;
&#xD;
          -  Suffering with other disease(s) requiring long-term oral anticoagulation treatment;&#xD;
&#xD;
          -  Initial untreated AF, or secondary AF with clear cause (such as hyperthyroid heart&#xD;
             disease);&#xD;
&#xD;
          -  Intracardiac thrombus (including left and/or right atrium) found or persisted;&#xD;
&#xD;
          -  Suffered with myocardial infarction within 3 months;&#xD;
&#xD;
          -  History of previous atrial septum repair operation or Atrial Septal Occluder&#xD;
             implantation;&#xD;
&#xD;
          -  History of previous heart valve (mechanical valve) replacement operation;&#xD;
&#xD;
          -  Subjects undergoing heart transplant operation;&#xD;
&#xD;
          -  Subjects with symptomatic carotid artery disease (such as carotid stenosis &gt; 50%) or&#xD;
             subjects with vulnerable carotid artery plaque.&#xD;
&#xD;
          -  Suffered with ischemic stroke or TIA recently (within 30 days);&#xD;
&#xD;
          -  Known complex active atherosclerotic plaque(s) in the descending aorta or aortic arch;&#xD;
&#xD;
          -  Severe heart failure (NYHA Grade Ⅳ);&#xD;
&#xD;
          -  The investigator assessed that there were abnormal result(s) with clinical&#xD;
             significance in the routine blood test of subjects；&#xD;
&#xD;
          -  Severe renal abnormal: serum creatinine &gt;250μmol/l; or on dialysis;&#xD;
&#xD;
          -  Allergic or contraindicated to aspirin, clopidogrel, heparin, contrast agent, and&#xD;
             nitinol alloy;&#xD;
&#xD;
          -  Subjects who are scheduled to receive operation within 1 year after procedure, and&#xD;
             need to stop anti-thrombotic therapy;&#xD;
&#xD;
          -  Pregnant or breast-feeding subjects, or subjects who plan to have a child within 1&#xD;
             year after procedure;&#xD;
&#xD;
          -  Subjects with a life expectancy less than 12 months;&#xD;
&#xD;
          -  Subjects who are participating in another investigational drug or device clinical&#xD;
             trial in which the primary endpoint is still not reached before enrolment;&#xD;
&#xD;
          -  Subjects have other reasons that cannot maintain 2 months anticoagulation or 6 months&#xD;
             dual antiplatelet therapy;&#xD;
&#xD;
          -  Subjects with poor compliance (judged by investigator) or cannot complete the study&#xD;
             according to the protocol due to other reasons;&#xD;
&#xD;
          -  Subjects who are unsuitable to receive LAA occlusion treatment (judged by&#xD;
             investigator).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming Zheng, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>MicroPort Orthopedics Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ben He, Prof.</last_name>
    <phone>0086-13701733685</phone>
    <email>heben@medmail.com.cn</email>
  </overall_contact>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>September 10, 2020</last_update_submitted>
  <last_update_submitted_qc>September 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>LAAC</keyword>
  <keyword>NVAF</keyword>
  <keyword>ischemic stroke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) will be shared. Additionally, study protocol will be available. The data will become available for the beginning 3 months and ending 5 years following article publication.&#xD;
If the data sharing plan changes after registration, this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>For the beginning 3 months and ending 5 years following article publication</ipd_time_frame>
    <ipd_access_criteria>(with) Researchers who provide a methodologically sound proposal. (For the analysis) To achieve aims in the approved proposal. (Requisite mechanism) Proposals should be directed to mzheng@microport.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included).</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04479722
org study id: SAFE-PROTECT
nct id: NCT04479722
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To evaluate the safety and efficacy of using Microport CardioAdvance Left Atrium Appendage
      Closure for preventing stroke in Non-valvular atrial fibrillation (NVAF) patients who have
      contraindications for long-term anti-coagulation. And to support registration approval from
      National Medical Products Administration (NMPA).
SAFE-PROTECT trial is composed of Roll-in group, small-size group and RCT group. This trial
      is planned to conduct in about 20 sites from China.

      Roll-in group plans to enroll at most 3 subjects each site to implant experimental device for
      exploration and observation.

      RCT group plans to enroll no less than 210 subjects who meet the inclusion/exclusion
      criteria, and 1:1 randomly allocated to experimental arm or comparator arm.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Clinical success
time frame: 12-month
description: Freedom from ischemic stroke, hemorrhagic stroke, systemic embolism, cardiovascular death and unexplained death
measure: LAA occlusion success
time frame: 12-month
description: TEE examination showing that the residual shunt < 5mm jet width or complete occlusion of LAA
arm group label: Microport CardioAdvance LAAC system
arm group type: Experimental
description: Subject implant Microport CardioAdvance LAAC system to occlude LAA through percutaneous intervention.
arm group label: Watchman LAAC system
arm group type: Active Comparator
description: Subject implant Watchman LAAC system to occlude LAA through percutaneous intervention.
intervention type: Device
intervention name: Left atrial appendage closure procedure
description: Implant LAAC system in LAA through percutaneous intervention
arm group label: Microport CardioAdvance LAAC system
arm group label: Watchman LAAC system
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ming Zheng, Prof.
role: Study Chair
affiliation: MicroPort Orthopedics Inc.
last name: Ben He, Prof.
phone: 0086-13701733685
email: heben@medmail.com.cn
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Atrial Fibrillation
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices) will be shared. Additionally, study protocol will be available. The data will become available for the beginning 3 months and ending 5 years following article publication.
If the data sharing plan changes after registration, this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.
ipd info type: Study Protocol
ipd time frame: For the beginning 3 months and ending 5 years following article publication
ipd access criteria: (with) Researchers who provide a methodologically sound proposal. (For the analysis) To achieve aims in the approved proposal. (Requisite mechanism) Proposals should be directed to mzheng@microport.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included).