<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/NCT03014557</url>
  </required_header>
  <id_info>
    <org_study_id>T2016-ZX021</org_study_id>
    <nct_id>NCT03014557</nct_id>
  </id_info>
  <brief_title>China REgistry of WATCHMAN</brief_title>
  <acronym>CREW</acronym>
  <official_title>China REgistry of WATCHMAN Left Atrial Appendage Closure for Non-valvular Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fu Wai Hospital, Beijing, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fu Wai Hospital, Beijing, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This registry is designed to observe the safety and effectiveness of WATCHMAN left atrial&#xD;
      appendage closure technology in a Chinese population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this prospective, multi-center, single arm observational study, 413 patients with&#xD;
      non-valvular atrial fibrillation intended to be implanted with a WATCHMAN device based on&#xD;
      real clinical practice will be enrolled. Enrolled subjects will be followed up for 5&#xD;
      years.Primary endpoints include stroke, systematic embolism, cardiovascular death, and&#xD;
      procedure or device related complications, etc.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>all-cause death, ischemic stroke, systemic embolism, or device or procedure related events</measure>
    <time_frame>between the time of enrollment and within 7 days of the procedure or by hospital discharge, whichever is later</time_frame>
    <description>events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>composite endpoint of hemorrhagic stroke, ischemic stroke, systemic embolism or cardiovascular/unexplained death.</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implantation success rate.</measure>
    <time_frame>procedure</time_frame>
    <description>Implantation success is defined as successful delivery and release of WATCHMAN into the LAA including successful recapture and retrieval if necessary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ischemic stroke or systemic embolism</measure>
    <time_frame>excluding the first 7 days post enrollment.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All Major Complications.</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Major complication is defined as death, stroke, MI or any other serious adverse events related to the device or procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause death.</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">413</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Left Atrial Appendage Closure</condition>
  <arm_group>
    <arm_group_label>WATCHMAN</arm_group_label>
    <description>subjects with non-valvular atrial fibrillation intended to be implanted with a WATCHMAN left atrial appendage closure device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>left atrial appendage closure device implantation</intervention_name>
    <description>to permanently implant a WATCHMAN left atrial appendage closure device through trans-catheter approach</description>
    <arm_group_label>WATCHMAN</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        non-valvular atrial fibrillation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Non-valvular atrial fibrillation patient with CHA2DS2-VASC≥2, and with any one of the&#xD;
        following items:&#xD;
&#xD;
          1. not suitable for long-term anti-coagulation therapy;&#xD;
&#xD;
          2. stroke or embolism events in spite of warfarin treatment with intended INR&#xD;
&#xD;
          3. HAS-BLED≥3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patient with any one of the following items will be excluded from the study:&#xD;
&#xD;
        1. clinical exclusion criteria (any of the items) a congestive heart failure NYHA IV, b&#xD;
        atrial septum defect, ASD surgery or closure c cardioversion or catheter ablation is&#xD;
        planned within 30 days d with mechanic valve e left atrial appendage resection f heart&#xD;
        transplantation g symptomatic jugular artery disease h previous stroke or TIA within 30&#xD;
        days i long term warfarin therapy is needed or contraindicated to warfarin j&#xD;
        contraindicated to aspirin or clopidogrel k enrolled in other cardiac device or medicine&#xD;
        trials l pregnant women or plan to pregnant during the study period m estimated life &lt; 5&#xD;
        years&#xD;
&#xD;
        2 Echocardiography exclusion criteria (any of the items) a LVEF&lt;30% b thrombus or&#xD;
        spontaneous echo imaging detected within two days prior to procedure c patent foramen ovale&#xD;
        d cardiac tumor e left atrial appendage orifice diameter &gt;32mm or &lt; 17mm f the depth of&#xD;
        left atrial appendage is less than the width g prominent mitral stenosis (area &lt;1.5cm2)&#xD;
&#xD;
        3 subject is not able to or will not complete the follow ups as planned&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Zhengqin Zhai, MD PhD</last_name>
    <email>384358085@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Fuwai Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhengqin Zhai, MD PhD</last_name>
      <email>384358085@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fu Wai Hospital, Beijing, China</investigator_affiliation>
    <investigator_full_name>Shu Zhang</investigator_full_name>
    <investigator_title>Director of Department of Arrhythmia</investigator_title>
  </responsible_party>
  <keyword>atrial fibrillation</keyword>
  <keyword>left atrial appendage closure</keyword>
  <keyword>WATCHMAN</keyword>
  <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>
  </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/NCT03014557
org study id: T2016-ZX021
nct id: NCT03014557
lead sponsor: 
collaborator: 
has dmc: Yes
This registry is designed to observe the safety and effectiveness of WATCHMAN left atrial
      appendage closure technology in a Chinese population.
In this prospective, multi-center, single arm observational study, 413 patients with
      non-valvular atrial fibrillation intended to be implanted with a WATCHMAN device based on
      real clinical practice will be enrolled. Enrolled subjects will be followed up for 5
      years.Primary endpoints include stroke, systematic embolism, cardiovascular death, and
      procedure or device related complications, etc.
observational model: Cohort
time perspective: Prospective
measure: all-cause death, ischemic stroke, systemic embolism, or device or procedure related events
time frame: between the time of enrollment and within 7 days of the procedure or by hospital discharge, whichever is later
description: events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair.
measure: composite endpoint of hemorrhagic stroke, ischemic stroke, systemic embolism or cardiovascular/unexplained death.
time frame: 2 years
measure: Implantation success rate.
time frame: procedure
description: Implantation success is defined as successful delivery and release of WATCHMAN into the LAA including successful recapture and retrieval if necessary.
measure: Ischemic stroke or systemic embolism
time frame: excluding the first 7 days post enrollment.
measure: All Major Complications.
time frame: up to 5 years
description: Major complication is defined as death, stroke, MI or any other serious adverse events related to the device or procedure.
measure: All-cause death.
time frame: up to 5 years
arm group label: WATCHMAN
description: subjects with non-valvular atrial fibrillation intended to be implanted with a WATCHMAN left atrial appendage closure device
intervention type: Device
intervention name: left atrial appendage closure device implantation
description: to permanently implant a WATCHMAN left atrial appendage closure device through trans-catheter approach
arm group label: WATCHMAN
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Zhengqin Zhai, MD PhD
email: 384358085@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fu Wai Hospital, Beijing, China
investigator full name: Shu Zhang
investigator title: Director of Department of Arrhythmia
mesh term: Atrial Fibrillation
sharing ipd: No