<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/NCT03795298</url>
  </required_header>
  <id_info>
    <org_study_id>S2239</org_study_id>
    <nct_id>NCT03795298</nct_id>
  </id_info>
  <brief_title>Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation</brief_title>
  <acronym>OPTION</acronym>
  <official_title>Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to determine if left atrial appendage closure with the&#xD;
      WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following&#xD;
      percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective, randomized, multi-center, global investigation to determine if&#xD;
      left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to&#xD;
      oral anticoagulation in patients after AF ablation.&#xD;
&#xD;
      A subject who signs informed consent is considered enrolled in the study. Subjects will be&#xD;
      randomized to OAC or WATCHMAN FLX in equal fashion. Randomization will be stratified by&#xD;
      sequential vs. concomitant planned ablation +/- WATCHMAN implantation, to help ensure balance&#xD;
      of treatment assignments within the sequential and concomitant groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 20, 2019</start_date>
  <completion_date type="Anticipated">November 2024</completion_date>
  <primary_completion_date type="Anticipated">November 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <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>Stroke, all cause death, and systemic embolism</measure>
    <time_frame>36 months</time_frame>
    <description>WATCHMAN therapy is non-inferior for the occurrence of stroke (including ischemic and/or hemorrhagic), all cause death, and systemic embolism.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-procedural bleeding</measure>
    <time_frame>36 months</time_frame>
    <description>WATCHMAN therapy is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major bleeding</measure>
    <time_frame>36 months</time_frame>
    <description>WATCHMAN therapy is non-inferior for ISTH major bleeding (including procedural bleeding).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1600</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>WATCHMAN FLX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>WATCHMAN FLX implant including modified post-implant drug regimen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Market-approved OAC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>WATCHMAN FLX Implant</intervention_name>
    <description>Left atrial appendage closure with the WATCHMAN FLX device</description>
    <arm_group_label>WATCHMAN FLX</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Market-approved OAC</intervention_name>
    <description>Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.</description>
    <arm_group_label>Market-approved OAC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject is of legal age to participate in the study per the laws of their&#xD;
             respective geography.&#xD;
&#xD;
          2. Underwent a prior catheter ablation procedure for non-valvular AF between 90 and 180&#xD;
             days prior to randomization (sequential) or is planning to have clinically indicated&#xD;
             catheter ablation within 10 days of randomization (concomitant).&#xD;
&#xD;
          3. The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or&#xD;
             greater for females.&#xD;
&#xD;
          4. The subject is deemed to be suitable for the defined protocol pharmacologic regimen.&#xD;
&#xD;
          5. The subject is able to undergo TEE examinations.&#xD;
&#xD;
          6. The subject or legal representative is able to understand and is willing to provide&#xD;
             written informed consent to participate in the trial.&#xD;
&#xD;
          7. The subject is able and willing to return for required follow-up visits and&#xD;
             examinations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The subject is currently enrolled in another investigational study that would directly&#xD;
             interfere with the current study, except when the subject is participating in a&#xD;
             mandatory governmental registry, or a purely observational registry with no associated&#xD;
             treatments. Each instance must be brought to the attention of the sponsor to determine&#xD;
             eligibility, regardless of type of co-enrollment being proposed.&#xD;
&#xD;
          2. The subject requires long-term anticoagulation therapy for reasons other than&#xD;
             AF-related stroke risk reduction, for example due to an underlying hypercoagulable&#xD;
             state (i.e., even if the device is implanted, the subjects would not be eligible to&#xD;
             discontinue OAC due to other medical conditions requiring chronic OAC therapy).&#xD;
&#xD;
          3. The subject is deemed by the treating physician to be unsuitable for chronic&#xD;
             anticoagulation and/or aspirin therapy due to bleeding risk, allergy, or other&#xD;
             reasons.&#xD;
&#xD;
          4. The subject had or is planning to have any cardiac or major non-cardiac interventional&#xD;
             or surgical procedure (excluding non-valvular AF ablation and cardioversion) within 30&#xD;
             days prior to or 60 days after randomization [including, but not limited to:&#xD;
             percutaneous coronary intervention (PCI), other cardiac ablation (VT ablation, etc.),&#xD;
             etc.].&#xD;
&#xD;
          5. The subject had a stroke or transient ischemic attack (TIA) within the 60 days prior&#xD;
             to randomization.&#xD;
&#xD;
          6. The subject had a prior major bleeding event per ISTH definition within the 14 days&#xD;
             prior to randomization. Lack of resolution of related clinical sequelae, or planned&#xD;
             and pending interventions to resolve bleeding/bleeding source, are a further exclusion&#xD;
             regardless of timing of the bleeding event.&#xD;
&#xD;
          7. The subject has had a myocardial infarction (MI) documented in the clinical record as&#xD;
             either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or&#xD;
             without intervention, within 90 days prior to randomization.&#xD;
&#xD;
          8. The subject has a history of atrial septal repair or has an ASD/PFO device.&#xD;
&#xD;
          9. The subject has an implanted mechanical valve prosthesis in any position.&#xD;
&#xD;
         10. The subject is of childbearing potential and is, or plans to become pregnant during&#xD;
             the time of the study (method of assessment upon study physician's discretion)&#xD;
&#xD;
         11. The subject has a documented life expectancy of less than two years.&#xD;
&#xD;
         12. The subject has a cardiac tumor.&#xD;
&#xD;
         13. The subject has signs/symptoms of acute or chronic pericarditis.&#xD;
&#xD;
         14. There is evidence of tamponade physiology.&#xD;
&#xD;
         15. Contraindications (anatomical or medical) to percutaneous catheterization procedures.&#xD;
&#xD;
         16. The subject has documented NYHA Class IV heart failure.&#xD;
&#xD;
         17. The subject has documented surgical closure of the left atrial appendage.&#xD;
&#xD;
         18. The subject has an active infection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Oussama Wazni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grandview Medical Center</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Center Research</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alaska Regional Hospital</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Arrhythmia Research Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Phoenix Cardiovascular Research Group</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Bernard's Medical Center</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Clinic Arkansas</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mills Peninsula Health Services</name>
      <address>
        <city>Burlingame</city>
        <state>California</state>
        <zip>94010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scripps Memorial Hospital</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marin General Hospital</name>
      <address>
        <city>Larkspur</city>
        <state>California</state>
        <zip>94939</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Southern California Hospital</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sharp Memorial Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Santa Clara Medical Center</name>
      <address>
        <city>Santa Clara</city>
        <state>California</state>
        <zip>95051</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marian Regional Medical Center</name>
      <address>
        <city>Santa Maria</city>
        <state>California</state>
        <zip>93454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Robles Hospital &amp; Medical Center</name>
      <address>
        <city>Thousand Oaks</city>
        <state>California</state>
        <zip>91360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hospital</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centura Health</name>
      <address>
        <city>Littleton</city>
        <state>Colorado</state>
        <zip>80120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center of the Rockies (Loveland)</name>
      <address>
        <city>Loveland</city>
        <state>Colorado</state>
        <zip>80538</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manatee Memorial Hospital</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Broward General Medical Center</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent's Medical Center</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AdventHealth Ocala</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tallahassee Memorial Hospital</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellstar Kennestone Hospital</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Alphonsus Regional Medical Center</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Lukes Idaho Cardiology Associates</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edward Hospital</name>
      <address>
        <city>Naperville</city>
        <state>Illinois</state>
        <zip>60540</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. John's Hospital</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Hospital of Indianapolis</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent Heart Center of Indiana</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46290</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Heart Center</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Overland Park Regional Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas City Cardiac Arrhythmia Research</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Health Lexington</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lahey Clinic Hospital</name>
      <address>
        <city>Burlington</city>
        <state>Massachusetts</state>
        <zip>01805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MyMichigan Medical Center Midland</name>
      <address>
        <city>Midland</city>
        <state>Michigan</state>
        <zip>48670</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abbott Northwestern Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HealthEast St. Joseph's Hospital</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Hospital of Kansas City</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Research</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Heart Institute</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catholic Medical Center</name>
      <address>
        <city>Manchester</city>
        <state>New Hampshire</state>
        <zip>03102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Associates of the Delaware Valley</name>
      <address>
        <city>Haddon Heights</city>
        <state>New Jersey</state>
        <zip>08035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Hospital</name>
      <address>
        <city>Ridgewood</city>
        <state>New Jersey</state>
        <zip>07450</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health</name>
      <address>
        <city>Bay Shore</city>
        <state>New York</state>
        <zip>11706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Medical Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rex Hospital</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lindner Center for Research and Education at Christ Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OhioHealth Research and Innovation Institute - Riverside Methodist Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pinnacle Health at Harrisburg Hospital</name>
      <address>
        <city>Harrisburg</city>
        <state>Pennsylvania</state>
        <zip>17101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presbyterian University of Pennsylvania Medical Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lankenau Institute for Medical Research</name>
      <address>
        <city>Wynnewood</city>
        <state>Pennsylvania</state>
        <zip>19096</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>York Hospital</name>
      <address>
        <city>York</city>
        <state>Pennsylvania</state>
        <zip>17403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centennial Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Thomas Health</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Cardiac Arrhythmia Research</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HeartPlace Mid-Cities EP</name>
      <address>
        <city>Bedford</city>
        <state>Texas</state>
        <zip>76021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Heart Hospital Baylor Plano</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Clinic of San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christus Trinity Mother Frances Health System</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mark's Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chippenham Medical Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI Franciscan Health System</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PeaceHealth Southwest Medical</name>
      <address>
        <city>Vancouver</city>
        <state>Washington</state>
        <zip>98664</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monongalia General Hospital</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University Hospitals</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advara HeartCare</name>
      <address>
        <city>Brisbane</city>
        <state>Queensland</state>
        <zip>4120 QLD</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Health</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onze Lieve Vrouw Ziekenhuis</name>
      <address>
        <city>Aalst</city>
        <state>East Flanders</state>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Lille</name>
      <address>
        <city>Lille</city>
        <state>Hauts-de-France</state>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Pitie-Salpetriere</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Grenoble - Hopital Michallon</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Europeen Georges-Pompidou</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Pasteur</name>
      <address>
        <city>Toulouse</city>
        <zip>31076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hôpital Universitaire Rangueil</name>
      <address>
        <city>Toulouse</city>
        <zip>31400</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <state>Île-de-France</state>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DHZC - Deutsches Herzzentrum der Charité</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik für Kardiologie, Angiologie und Intensivmedizin Mittelallee</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Coburg GmbH</name>
      <address>
        <city>Coburg</city>
        <zip>96450</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St.Johann Nepomuk Katholisches Hospitalvereinigung Thüringen GmbH</name>
      <address>
        <city>Erfurt</city>
        <zip>99097</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardioangiologisches Centrum Bethanien</name>
      <address>
        <city>Frankfurt</city>
        <zip>60431</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinik Greifswald</name>
      <address>
        <city>Greifswald</city>
        <zip>17475</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik Saint Georg</name>
      <address>
        <city>Hamburg</city>
        <zip>20099</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allgemeines Krankenhaus Altona</name>
      <address>
        <city>Hamburg</city>
        <zip>22763</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum St. Georg</name>
      <address>
        <city>Leipzig</city>
        <zip>4129</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Schleswig-Holstein</name>
      <address>
        <city>Lübeck</city>
        <zip>D-23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Josefs-Hospital GmbH</name>
      <address>
        <city>Wiesbaden</city>
        <zip>65189</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Cardiologico Monzino</name>
      <address>
        <city>Milano</city>
        <zip>20138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino</name>
      <address>
        <city>Torino</city>
        <zip>10123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Antonius Ziekenhuis</name>
      <address>
        <city>Nieuwegein</city>
        <state>Utrecht</state>
        <zip>3430 EM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gornoslaskie Centrum Medyczne im. Prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach Ziolow</name>
      <address>
        <city>Katowice</city>
        <zip>40635</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinical Hospital in Poznań/ UNIWERSYTECKI SZPITAL KLINICZNY W POZNANIU</name>
      <address>
        <city>Poznan</city>
        <zip>61-848</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Slaskie Centrum Chorob Serca</name>
      <address>
        <city>Zabrze</city>
        <zip>41800</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario</name>
      <address>
        <city>Alicante</city>
        <zip>3010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Puerta Del Mar</name>
      <address>
        <city>Cadiz</city>
        <zip>11009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universidad de Navarra</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinico de Valladolid</name>
      <address>
        <city>Valladolid</city>
        <zip>47005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Alvaro Cunqueiro</name>
      <address>
        <city>Vigo</city>
        <zip>36312</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>August 18, 2023</last_update_submitted>
  <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non-valvular atrial fibrillation</keyword>
  <keyword>Left atrial appendage</keyword>
  <keyword>Ablation</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>Yes</sharing_ipd>
    <ipd_url>http://www.bostonscientific.com/content/gwc/en-US/data-sharing-requests.html</ipd_url>
  </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/NCT03795298
org study id: S2239
nct id: NCT03795298
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The primary objective of this study is to determine if left atrial appendage closure with the
      WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following
      percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.
This study is a prospective, randomized, multi-center, global investigation to determine if
      left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to
      oral anticoagulation in patients after AF ablation.

      A subject who signs informed consent is considered enrolled in the study. Subjects will be
      randomized to OAC or WATCHMAN FLX in equal fashion. Randomization will be stratified by
      sequential vs. concomitant planned ablation +/- WATCHMAN implantation, to help ensure balance
      of treatment assignments within the sequential and concomitant groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Stroke, all cause death, and systemic embolism
time frame: 36 months
description: WATCHMAN therapy is non-inferior for the occurrence of stroke (including ischemic and/or hemorrhagic), all cause death, and systemic embolism.
measure: Non-procedural bleeding
time frame: 36 months
description: WATCHMAN therapy is superior for non-procedural bleeding (ISTH major bleeding and clinically relevant non-major bleeding).
measure: Major bleeding
time frame: 36 months
description: WATCHMAN therapy is non-inferior for ISTH major bleeding (including procedural bleeding).
arm group label: WATCHMAN FLX
arm group type: Experimental
description: WATCHMAN FLX implant including modified post-implant drug regimen.
arm group label: Market-approved OAC
arm group type: Active Comparator
description: Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.
intervention type: Device
intervention name: WATCHMAN FLX Implant
description: Left atrial appendage closure with the WATCHMAN FLX device
arm group label: WATCHMAN FLX
intervention type: Drug
intervention name: Market-approved OAC
description: Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.
arm group label: Market-approved OAC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Oussama Wazni, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
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country: Australia
country: Belgium
country: Denmark
country: France
country: Germany
country: Italy
country: Netherlands
country: Poland
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: Yes
ipd url: http://www.bostonscientific.com/content/gwc/en-US/data-sharing-requests.html