<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/NCT03033134</url>
  </required_header>
  <id_info>
    <org_study_id>S6001</org_study_id>
    <nct_id>NCT03033134</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W</brief_title>
  <acronym>SALUTE</acronym>
  <official_title>A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W for Patients With Non-valvular Atrial Fibrillation at Increased Risk of ThromboEmbolism in Japanese Medical Environment (SALUTE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Japan K.K.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Japan K.K.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to confirm the safety and effectiveness of the BSJ003W in&#xD;
      Japanese patients with non-valvular atrial fibrillation at increased risk of thromboembolism&#xD;
      in Japanese Clinical environment&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 27, 2017</start_date>
  <completion_date type="Actual">September 5, 2019</completion_date>
  <primary_completion_date type="Actual">February 1, 2018</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Complications; One of the Following Events</measure>
    <time_frame>Between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later</time_frame>
    <description>All-cause death, ischemic stroke, systemic embolism, or device- or procedure- related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, arteriolar-venular fistula repair, or other major endovascular repair.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause)</measure>
    <time_frame>24-month</time_frame>
    <description>The occurrence of composite events including stroke (all/ ischemic/ hemorrhagic), systemic embolism and cardiovascular death (including unexplained cause) till 6-month post implant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Rate of Effective Left Atrial Appendage (LAA) Closure</measure>
    <time_frame>45-day, 6-month, 12-month</time_frame>
    <description>The effective LAA closure is defined as peri-device flow &lt;= 5mm demonstrated by TEE.&#xD;
TEE measurements will be assessed by an independent Core Laboratory.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Major Bleeding</measure>
    <time_frame>24-month</time_frame>
    <description>Major bleeding is defined as per BARC bleeding definition type 3 or 5.&#xD;
Type 3 Type 3a: Overt bleeding plus hemoglobin drop of 3 to 5 g/dL* (provided hemoglobin drop is related to bleed), Any transfusion with overt bleeding&#xD;
Type 3b: Overt bleeding plus hemoglobin drop 5 g/dL* (provided hemoglobin drop is related to bleed) Cardiac tamponade, Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid), Bleeding requiring intravenous vasoactive agents&#xD;
Type 3c: Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal), Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision&#xD;
Type 5: fatal bleeding Type 5a: Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious Type 5b: Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Overt Non-fatal Bleeding</measure>
    <time_frame>24-month</time_frame>
    <description>Clinically overt non-fatal bleeding is defined as per BARC bleeding definition type 2.&#xD;
Type 2: any overt, actionable sign of hemorrhage (eg, more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for type 3, 4, or 5 but does meet at least one of the following criteria: (1) requiring nonsurgical, medical intervention by a healthcare professional, (2) leading to hospitalization or increased level of care, or (3) prompting evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Ischemic Stroke or Systemic Embolism</measure>
    <time_frame>24-month</time_frame>
    <description>The occurrence of ischemic stroke or systemic embolism (excluding 7 days after implanting or day after hospital discharge whichever is the later)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Technical Success Rate</measure>
    <time_frame>Implant Day</time_frame>
    <description>Technical Success defined as successful delivery and release of BSJ003W into the LAA including successful recapture and retrieval if necessary.</description>
  </other_outcome>
  <other_outcome>
    <measure>Warfarin Discontinuation Rate</measure>
    <time_frame>45-day, 6-month, 12-month</time_frame>
    <description>Warfarin discontinuation rate per protocol. If the TEE shows adequate seal of the LAA with a jet around the device &lt;= 5mm, warfarin therapy should be discontinued.&#xD;
Some patients restarted warfarin therapy due to the reasons other than the status of LAA closure.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Atrial Fibrillation Non-Rheumatic</condition>
  <arm_group>
    <arm_group_label>BSJ003W</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BSJ003W implant group</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BSJ003W</intervention_name>
    <description>BSJ003W implant</description>
    <arm_group_label>BSJ003W</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject is Japanese, over 20 years old and provides written informed consent to&#xD;
             participate in the trial&#xD;
&#xD;
          2. The subject has documented paroxysmal, persistent or permanent non-valvular atrial&#xD;
             fibrillation&#xD;
&#xD;
          3. The subject has a calculated CHA2DS2-VASc score of 2 or greater and is recommended for&#xD;
             long-term oral anti-coagulation therapy&#xD;
&#xD;
          4. The subject is deemed by their physicians to be suitable for anticoagulant therapy and&#xD;
             have an appropriate rationale to seek a non-pharmacologic alternative to warfarin&#xD;
&#xD;
          5. The subject is eligible to come off warfarin therapy if the LAA (left atrial&#xD;
             appendage) is sealed (i.e. the subject has no other conditions that would require&#xD;
             warfarin therapy).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The subject has a prior stroke (ischemic or hemorrhagic) or transient ischemic attack&#xD;
             within the 90 days prior to consent&#xD;
&#xD;
          2. The subject has had a myocardial infarction either non-ST elevation or ST elevation&#xD;
             myocardial infarction within 90 days prior to consent with or without intervention&#xD;
&#xD;
          3. The subject had or is planning to have any cardiac (e.g. cardioversion, coronary&#xD;
             angiogram, percutaneous coronary intervention, cardiac ablation, etc.) or non-cardiac&#xD;
             invasive or surgical procedure (e.g. cataract surgery, endoscopy, etc.) within 30 days&#xD;
             prior or 45 days after the BSJ003W implant&#xD;
&#xD;
          4. The subject has a history of atrial septal repair or has an atrial septal&#xD;
             defect/persistent foramen ovale device&#xD;
&#xD;
          5. The subject has an implanted mechanical valve prosthesis in any position&#xD;
&#xD;
          6. The subject currently New York Heart Association class IV congestive heart failure&#xD;
&#xD;
          7. The subject is contraindicated to aspirin&#xD;
&#xD;
          8. The subject is contraindicated or seriously allergic to thienopyridine&#xD;
&#xD;
          9. The subject is of childbearing potential and is, or plans to become pregnant during&#xD;
             the time of the study&#xD;
&#xD;
         10. The subject is not able and willing to return for required follow-up visits and&#xD;
             examinations&#xD;
&#xD;
         11. Subjects who are currently enrolled in another investigational study (of which primary&#xD;
             endpoint follow-up have not been completed yet).&#xD;
&#xD;
         12. The subject has other reason not to be eligible for this study per investigators'&#xD;
             discretion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kazutaka Aonuma</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tsukuba University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shigeru Saito</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shonankamakura General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kokura Memorial Hospital</name>
      <address>
        <city>Kitakyushu</city>
        <state>Fukuoka</state>
        <zip>802-8255</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tsukuba Hospital</name>
      <address>
        <city>Tsukuba</city>
        <state>Ibaraki</state>
        <zip>305-8576</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iwate Medical University Hospital</name>
      <address>
        <city>Morioka</city>
        <state>Iwate</state>
        <zip>020-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shonan Kamakura General Hospital</name>
      <address>
        <city>Kamakura-city</city>
        <state>Kanagawa</state>
        <zip>247-8533</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sendai Kousei Hospital</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <zip>980-0873</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cerebral and Cardiovascular Center</name>
      <address>
        <city>Suita</city>
        <state>Osaka</state>
        <zip>565-8565</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical and Dental University Medical Hospital</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8519</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sakakibara Heart Institute</name>
      <address>
        <city>Fuchu</city>
        <state>Tokyo</state>
        <zip>183-0003</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toho University Ohashi Medical Center</name>
      <address>
        <city>Meguro-ku</city>
        <state>Tokyo</state>
        <zip>153-8515</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>160-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <results_first_submitted>October 15, 2018</results_first_submitted>
  <results_first_submitted_qc>December 18, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">January 8, 2019</results_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The confidentiality of records/data obtained in the trial will remain anonymous for analysis and publication.&#xD;
The information and data, obtained from the trial is used without personal identification</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 24, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT03033134/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT03033134/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Implant (ITT)</title>
          <description>BSJ003W implant group (ITT) : 42 subjects</description>
        </group>
        <group group_id="P2">
          <title>Roll-in</title>
          <description>12 Roll-in subjects</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>6-month Primary Endpoints</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Implant (ITT)</title>
          <description>Implant (ITT) group: 42 subjects</description>
        </group>
        <group group_id="B2">
          <title>Roll-in</title>
          <description>Roll-in group: 12 subjects</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="42"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="54"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72.5" spread="8.8"/>
                    <measurement group_id="B2" value="70.6" spread="7.4"/>
                    <measurement group_id="B3" value="72.1" spread="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CHA2DS2-VASc score</title>
          <description>CHA2DS2-VASc score is recommended to assess stroke risk. CHA2DS2-VASc score is calculated by the summed of the following factors; C:1: Congestive Heart Failure/ LV dysfunction, H:1: Hypertension, A:2: Age &gt;75, D:1: Diabetes, S:2: Stroke/ TIA, V:1: Vascular disease, A:1: Age 65-74, Sc:1: Female.&#xD;
Total Score range: 0-9. Higher score indicates the higher stroke risk.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.6" spread="1.6"/>
                    <measurement group_id="B2" value="3.5" spread="1.6"/>
                    <measurement group_id="B3" value="3.6" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Atrial Fibrillation pattern</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Documented Paroxysmal</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Documented Persistent</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Documented Permanent</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HAS-BLED score</title>
          <description>HAS-BLED score is a Bleeding risk scores to quantify hemorrhage risk. HAS-BLED score is calculated by the summed of the following factors; H: Hypertension, A: Abnormal renal function, Abnormal liver function, S: Stroke, B: Bleeding, L: Labile INRs, E: Elderly &gt; 65 years, D: Drugs (NSAIDs) or Alcohol.&#xD;
Total Score Range: 0-9. Higher score indicates higher bleeding risk.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.9" spread="1.1"/>
                    <measurement group_id="B2" value="3.1" spread="1.1"/>
                    <measurement group_id="B3" value="3.0" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Complications; One of the Following Events</title>
        <description>All-cause death, ischemic stroke, systemic embolism, or device- or procedure- related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, arteriolar-venular fistula repair, or other major endovascular repair.</description>
        <time_frame>Between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Implant (ITT)</title>
            <description>Implant (ITT) group: 42 subjects</description>
          </group>
          <group group_id="O2">
            <title>Roll-in</title>
            <description>Roll-in cohort</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Complications; One of the Following Events</title>
          <description>All-cause death, ischemic stroke, systemic embolism, or device- or procedure- related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, arteriolar-venular fistula repair, or other major endovascular repair.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause)</title>
        <description>The occurrence of composite events including stroke (all/ ischemic/ hemorrhagic), systemic embolism and cardiovascular death (including unexplained cause) till 6-month post implant</description>
        <time_frame>24-month</time_frame>
        <population>Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Implant (ITT)</title>
            <description>Implant (ITT) group: 42 subjects</description>
          </group>
          <group group_id="O2">
            <title>Roll-in</title>
            <description>Roll-in cohort: 12 subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause)</title>
          <description>The occurrence of composite events including stroke (all/ ischemic/ hemorrhagic), systemic embolism and cardiovascular death (including unexplained cause) till 6-month post implant</description>
          <population>Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ischemic stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemorrhagic stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systemic embolism</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiovascular death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Rate of Effective Left Atrial Appendage (LAA) Closure</title>
        <description>The effective LAA closure is defined as peri-device flow &lt;= 5mm demonstrated by TEE.&#xD;
TEE measurements will be assessed by an independent Core Laboratory.</description>
        <time_frame>45-day, 6-month, 12-month</time_frame>
        <population>Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.&#xD;
One subject in Roll-in cohort at 6-month was not able to assessed by the Core laboratory due to the quality of the images</population>
        <group_list>
          <group group_id="O1">
            <title>Implant (ITT)</title>
            <description>Implant (ITT) group: 42 subjects</description>
          </group>
          <group group_id="O2">
            <title>Roll-in</title>
            <description>Roll-in cohort: 12 subjects</description>
          </group>
        </group_list>
        <measure>
          <title>The Rate of Effective Left Atrial Appendage (LAA) Closure</title>
          <description>The effective LAA closure is defined as peri-device flow &lt;= 5mm demonstrated by TEE.&#xD;
TEE measurements will be assessed by an independent Core Laboratory.</description>
          <population>Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.&#xD;
One subject in Roll-in cohort at 6-month was not able to assessed by the Core laboratory due to the quality of the images</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At 45-day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 6-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 12-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Major Bleeding</title>
        <description>Major bleeding is defined as per BARC bleeding definition type 3 or 5.&#xD;
Type 3 Type 3a: Overt bleeding plus hemoglobin drop of 3 to 5 g/dL* (provided hemoglobin drop is related to bleed), Any transfusion with overt bleeding&#xD;
Type 3b: Overt bleeding plus hemoglobin drop 5 g/dL* (provided hemoglobin drop is related to bleed) Cardiac tamponade, Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid), Bleeding requiring intravenous vasoactive agents&#xD;
Type 3c: Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal), Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision&#xD;
Type 5: fatal bleeding Type 5a: Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious Type 5b: Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation</description>
        <time_frame>24-month</time_frame>
        <population>Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Implant (ITT)</title>
            <description>Implant (ITT) group: 42 subjects</description>
          </group>
          <group group_id="O2">
            <title>Roll-in</title>
            <description>Roll-in cohort: 12 subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Major Bleeding</title>
          <description>Major bleeding is defined as per BARC bleeding definition type 3 or 5.&#xD;
Type 3 Type 3a: Overt bleeding plus hemoglobin drop of 3 to 5 g/dL* (provided hemoglobin drop is related to bleed), Any transfusion with overt bleeding&#xD;
Type 3b: Overt bleeding plus hemoglobin drop 5 g/dL* (provided hemoglobin drop is related to bleed) Cardiac tamponade, Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid), Bleeding requiring intravenous vasoactive agents&#xD;
Type 3c: Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal), Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision&#xD;
Type 5: fatal bleeding Type 5a: Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious Type 5b: Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation</description>
          <population>Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Overt Non-fatal Bleeding</title>
        <description>Clinically overt non-fatal bleeding is defined as per BARC bleeding definition type 2.&#xD;
Type 2: any overt, actionable sign of hemorrhage (eg, more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for type 3, 4, or 5 but does meet at least one of the following criteria: (1) requiring nonsurgical, medical intervention by a healthcare professional, (2) leading to hospitalization or increased level of care, or (3) prompting evaluation</description>
        <time_frame>24-month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Implant (ITT)</title>
            <description>Implant (ITT) group: 42 subjects</description>
          </group>
          <group group_id="O2">
            <title>Roll-in</title>
            <description>Roll-in cohort: 12 subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Overt Non-fatal Bleeding</title>
          <description>Clinically overt non-fatal bleeding is defined as per BARC bleeding definition type 2.&#xD;
Type 2: any overt, actionable sign of hemorrhage (eg, more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for type 3, 4, or 5 but does meet at least one of the following criteria: (1) requiring nonsurgical, medical intervention by a healthcare professional, (2) leading to hospitalization or increased level of care, or (3) prompting evaluation</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Ischemic Stroke or Systemic Embolism</title>
        <description>The occurrence of ischemic stroke or systemic embolism (excluding 7 days after implanting or day after hospital discharge whichever is the later)</description>
        <time_frame>24-month</time_frame>
        <population>Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Implant (ITT)</title>
            <description>Implant (ITT): 42 subjects</description>
          </group>
          <group group_id="O2">
            <title>Roll-in</title>
            <description>Roll-in cohort: 12 subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Ischemic Stroke or Systemic Embolism</title>
          <description>The occurrence of ischemic stroke or systemic embolism (excluding 7 days after implanting or day after hospital discharge whichever is the later)</description>
          <population>Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ischemic stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systemic embolism</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Technical Success Rate</title>
        <description>Technical Success defined as successful delivery and release of BSJ003W into the LAA including successful recapture and retrieval if necessary.</description>
        <time_frame>Implant Day</time_frame>
        <population>Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Implant (ITT)</title>
            <description>Implant (ITT) group: 42 subjects</description>
          </group>
          <group group_id="O2">
            <title>Roll-in</title>
            <description>Roll-in cohort: 12 subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Technical Success Rate</title>
          <description>Technical Success defined as successful delivery and release of BSJ003W into the LAA including successful recapture and retrieval if necessary.</description>
          <population>Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Warfarin Discontinuation Rate</title>
        <description>Warfarin discontinuation rate per protocol. If the TEE shows adequate seal of the LAA with a jet around the device &lt;= 5mm, warfarin therapy should be discontinued.&#xD;
Some patients restarted warfarin therapy due to the reasons other than the status of LAA closure.</description>
        <time_frame>45-day, 6-month, 12-month</time_frame>
        <population>Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Implant (ITT)</title>
            <description>Implant (ITT) group: 42 subjects</description>
          </group>
          <group group_id="O2">
            <title>Roll-in</title>
            <description>Roll-in cohort: 12 subjects</description>
          </group>
        </group_list>
        <measure>
          <title>Warfarin Discontinuation Rate</title>
          <description>Warfarin discontinuation rate per protocol. If the TEE shows adequate seal of the LAA with a jet around the device &lt;= 5mm, warfarin therapy should be discontinued.&#xD;
Some patients restarted warfarin therapy due to the reasons other than the status of LAA closure.</description>
          <population>Data collected from Roll-in subjects was analyzed separately from those data collected from ITT cohort.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At 45-day</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 6-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="42"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 12-month</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="41"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 years</time_frame>
      <desc>Based on the adverse events reported by the investigational site, the sponsor specific coding has been used to summarize adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Implant (ITT)</title>
          <description>Implant (ITT) group: 42 subjects</description>
        </group>
        <group group_id="E2">
          <title>Roll-in</title>
          <description>Roll-in cohort: 12 subjects</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>Internal difinitions</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Device Thrombus Atrial Facing - Post Procedure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Major Bleed Requiring Transfusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Pericarditis - Unrelated (Non Study) Procedure Or Device</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Sinus Bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Multiple Heart Failure Symptoms</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Chest Pain - Other</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Heart Failure Symptoms - Unspecified</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Sinus Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Torsades Des Pointes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Vetricular Tachycardia (VT) / Monomorphic VT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Chest Pain - Heart Failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Endocrine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal Bleeding</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Gastrointestinal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Head, Eyes, Ears, Norse, Throat (HEENT)</sub_title>
                <description>The AE name reported by the site was &quot;Chronic otitis media aggravated&quot;.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Led to Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Systemic Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Stroke (Ischemic)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Cranial Bleed - Without Stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Transient Ischemic Attack (TIA)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea - Heart Failure</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>Internal difinitions</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Endocrine</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal</sub_title>
                <counts group_id="E1" events="12" subjects_affected="8" subjects_at_risk="42"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Head, Eyes, Ears, Nose, Throat (Heent)</sub_title>
                <description>This AE term includes some symptoms or events reported by the site; ITT (19) includes Common cold (4), Pharyngitis (2), Vertigo (2), Root fracture (2).&#xD;
Roll-in (11) includes Common cold (6). The remaining AEs were reported in one event each.</description>
                <counts group_id="E1" events="19" subjects_affected="13" subjects_at_risk="42"/>
                <counts group_id="E2" events="11" subjects_affected="6" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Fever and/or Virus</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Abnormal Laboratory Values</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neurological</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="42"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Integumentary</sub_title>
                <counts group_id="E1" events="10" subjects_affected="6" subjects_at_risk="42"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Yutaka Gomi</name_or_title>
      <organization>Boston Scientific Japan</organization>
      <phone>+81.3.6853.7500</phone>
      <email>Yutaka.Gomi@bsci.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03033134
org study id: S6001
nct id: NCT03033134
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study is to confirm the safety and effectiveness of the BSJ003W in
      Japanese patients with non-valvular atrial fibrillation at increased risk of thromboembolism
      in Japanese Clinical environment
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Participants With Complications; One of the Following Events
time frame: Between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later
description: All-cause death, ischemic stroke, systemic embolism, or device- or procedure- related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, arteriolar-venular fistula repair, or other major endovascular repair.
measure: Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause)
time frame: 24-month
description: The occurrence of composite events including stroke (all/ ischemic/ hemorrhagic), systemic embolism and cardiovascular death (including unexplained cause) till 6-month post implant
measure: The Rate of Effective Left Atrial Appendage (LAA) Closure
time frame: 45-day, 6-month, 12-month
description: The effective LAA closure is defined as peri-device flow <= 5mm demonstrated by TEE.
TEE measurements will be assessed by an independent Core Laboratory.
measure: Number of Participants With Major Bleeding
time frame: 24-month
description: Major bleeding is defined as per BARC bleeding definition type 3 or 5.
Type 3 Type 3a: Overt bleeding plus hemoglobin drop of 3 to 5 g/dL* (provided hemoglobin drop is related to bleed), Any transfusion with overt bleeding
Type 3b: Overt bleeding plus hemoglobin drop 5 g/dL* (provided hemoglobin drop is related to bleed) Cardiac tamponade, Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid), Bleeding requiring intravenous vasoactive agents
Type 3c: Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal), Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision
Type 5: fatal bleeding Type 5a: Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious Type 5b: Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation
measure: Number of Participants With Clinically Overt Non-fatal Bleeding
time frame: 24-month
description: Clinically overt non-fatal bleeding is defined as per BARC bleeding definition type 2.
Type 2: any overt, actionable sign of hemorrhage (eg, more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for type 3, 4, or 5 but does meet at least one of the following criteria: (1) requiring nonsurgical, medical intervention by a healthcare professional, (2) leading to hospitalization or increased level of care, or (3) prompting evaluation
measure: Number of Participants With Ischemic Stroke or Systemic Embolism
time frame: 24-month
description: The occurrence of ischemic stroke or systemic embolism (excluding 7 days after implanting or day after hospital discharge whichever is the later)
measure: Technical Success Rate
time frame: Implant Day
description: Technical Success defined as successful delivery and release of BSJ003W into the LAA including successful recapture and retrieval if necessary.
measure: Warfarin Discontinuation Rate
time frame: 45-day, 6-month, 12-month
description: Warfarin discontinuation rate per protocol. If the TEE shows adequate seal of the LAA with a jet around the device <= 5mm, warfarin therapy should be discontinued.
Some patients restarted warfarin therapy due to the reasons other than the status of LAA closure.
arm group label: BSJ003W
arm group type: Experimental
description: BSJ003W implant group
intervention type: Device
intervention name: BSJ003W
description: BSJ003W implant
arm group label: BSJ003W
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Kazutaka Aonuma
role: Principal Investigator
affiliation: Tsukuba University Hospital
last name: Shigeru Saito
role: Principal Investigator
affiliation: Shonankamakura General Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No
ipd description: The confidentiality of records/data obtained in the trial will remain anonymous for analysis and publication.
The information and data, obtained from the trial is used without personal identification
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 