<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/NCT03835338</url>
  </required_header>
  <id_info>
    <org_study_id>S2236</org_study_id>
    <nct_id>NCT03835338</nct_id>
  </id_info>
  <brief_title>WATCHMAN for Concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation Rhythm</brief_title>
  <acronym>WATCH-Rhythm</acronym>
  <official_title>WATCHMAN for Concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation Rhythm</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_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      WATCH-Rhythm is a prospective, randomized, multi-center, investigation to collect safety and&#xD;
      effectiveness data on combining conventional AF ablation with LAA electric isolation and&#xD;
      closure within a single procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      WATCH-Rhythm is a prospective, randomized, multi-center, investigation to collect safety and&#xD;
      effectiveness data on combining conventional AF ablation with LAA electric isolation and&#xD;
      occlusion within a single procedure.&#xD;
&#xD;
      The primary objective is to test the effectiveness of adding LAA electrical isolation and&#xD;
      closure to conventional atrial fibrillation versus conventional atrial fibrillation alone in&#xD;
      treating patient with persistent atrial fibrillation from a single procedure.&#xD;
&#xD;
      This study will be conducted at up to 10 global sites in the European Union (United Kingdom,&#xD;
      Spain, Germany, or others). The maximum enrollment ceiling for the Watch-Rhythm study is 278&#xD;
      subjects. Included in the enrollment ceiling are up to 20 roll-in subjects and a maximum of&#xD;
      258 randomized subjects.&#xD;
&#xD;
      The duration of the study is expected to last approximately 4 years. Enrollment is expected&#xD;
      to take approximately 24 months. The duration of individual subject participation is expected&#xD;
      to last approximately 2 years but may vary per subject.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Sponsor discretion&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 1, 2021</start_date>
  <completion_date type="Anticipated">April 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Treatment Arm - PVI, LAA Isolation and WATCHMAN LAAC Implantation Control Arm - PVI</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Freedom from AF</measure>
    <time_frame>12 months</time_frame>
    <description>Not having any of the following after the blanking period:&#xD;
a documented symptomatic AF event (episode of 30 sec duration or longer by Holter, event monitor or rhythm strip; or for the full 10 second recording of a standard 12 lead ECG)&#xD;
treatment with a Class I or Class III AAD&#xD;
a documented symptomatic AF event (episode of 30 sec duration or longer by Holter, event monitor or rhythm strip; or for the full 10 second recording of a standard 12 lead ECG)&#xD;
treatment with a Class I or Class III AAD</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Persistent Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Test Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The test group will receive Pulmonary Vein Isolation, LAA Isolation and LAA Occlusion with the WATCHMAN LAAC Device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will receive Pulmonary Vein Isolation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pulmonary Vein Isolation</intervention_name>
    <description>Pulmonary Vein Isolation by RF Ablation</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Test Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LAA Isolation</intervention_name>
    <description>LAA Isolation by RF Ablation</description>
    <arm_group_label>Test Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LAA Occlusion</intervention_name>
    <description>LAA Occlusion by implantation of the WATCHMAN LAAC Device</description>
    <arm_group_label>Test Group</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. The subject has documented non-valvular persistent AF. For this protocol, the&#xD;
             definition of persistent AF is sustained arrhythmia lasting at least 7-days but less&#xD;
             than 36 months.&#xD;
&#xD;
          3. The subject is able to tolerate OAC post ablation.&#xD;
&#xD;
          4. Subject is able to undergo TEE.&#xD;
&#xD;
          5. The subject or legal representative is able to understand and willing to provide&#xD;
             written informed consent to participate in the trial&#xD;
&#xD;
          6. The subject is willing and capable of attending all follow-up visits at the&#xD;
             investigational site as medically appropriate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The subject is unable or unwilling to return for required follow-up visits and&#xD;
             examinations.&#xD;
&#xD;
          2. The subject had or is planning to have any invasive cardiac procedure within 30 days&#xD;
             prior to randomization (e.g., cardioversion, ablation).&#xD;
&#xD;
          3. Previous AF ablation (surgical or percutaneous).&#xD;
&#xD;
          4. Prior MAZE procedure.&#xD;
&#xD;
        4. The subject is planning to have any cardiac or non-cardiac invasive or surgical&#xD;
        procedure that would necessitate stopping or modifying the protocol required medication&#xD;
        regimen within 90 days after the WATCHMAN Closure Device implant (e.g., cardioversion,&#xD;
        ablation, cataract surgery).&#xD;
&#xD;
        5. The subject had a prior BARC type 3 or 4 bleeding event within the 14 days prior to&#xD;
        randomization. Lack of resolution of related clinical sequelae, or planned and pending&#xD;
        interventions to resolve bleeding/bleeding source, are a further exclusion regardless of&#xD;
        timing of the bleeding event.&#xD;
&#xD;
        6. The subject had a prior stroke (of any cause) or TIA within the 30 days prior to&#xD;
        randomization.&#xD;
&#xD;
        7. The subject had a prior BARC type 3 or 4 bleeding event within the 14 days prior to&#xD;
        randomization. Lack of resolution of related clinical sequelae, or planned and pending&#xD;
        interventions to resolve bleeding/bleeding source, or a further exclusion regardless of&#xD;
        timing of the bleeding event.&#xD;
&#xD;
        8. The subject has a history of atrial septal repair or has an ASD/PFO device. 9. The&#xD;
        subject has an implanted mechanical valve prosthesis in any position. 10. The subject&#xD;
        suffers from New York Heart Association Class IV Congestive Heart Failure.&#xD;
&#xD;
        11. Subject has LVEF &lt;30% 12. Subject has hypertrophic cardiomyopathy. 13. The subject has&#xD;
        had a myocardial infarction (MI) documented in the clinical record as either a non-ST&#xD;
        elevation MI (NSTEMI) or as an ST elevation MI (STEMI), with or without intervention,&#xD;
        within 90 days prior to randomization.&#xD;
&#xD;
        14. The subject is of childbearing potential and is, or plans to become pregnant during the&#xD;
        time of the study (method of assessment upon study physician's discretion).&#xD;
&#xD;
        15. The subject is currently enrolled in another investigational study or registry that&#xD;
        would directly interfere with the current study, except when the subject is participating&#xD;
        in a mandatory governmental registry, or a purely observational registry with no associated&#xD;
        treatments. Each instance should be brought to the attention of the sponsor to determine&#xD;
        eligibility.&#xD;
&#xD;
        16. The subject has a documented life expectancy of less than two years. 17. The subject&#xD;
        has a known or suspected hypercoagulable state&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>March 17, 2022</last_update_submitted>
  <last_update_submitted_qc>March 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</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>
  <!-- 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/NCT03835338
org study id: S2236
nct id: NCT03835338
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
WATCH-Rhythm is a prospective, randomized, multi-center, investigation to collect safety and
      effectiveness data on combining conventional AF ablation with LAA electric isolation and
      closure within a single procedure.
WATCH-Rhythm is a prospective, randomized, multi-center, investigation to collect safety and
      effectiveness data on combining conventional AF ablation with LAA electric isolation and
      occlusion within a single procedure.

      The primary objective is to test the effectiveness of adding LAA electrical isolation and
      closure to conventional atrial fibrillation versus conventional atrial fibrillation alone in
      treating patient with persistent atrial fibrillation from a single procedure.

      This study will be conducted at up to 10 global sites in the European Union (United Kingdom,
      Spain, Germany, or others). The maximum enrollment ceiling for the Watch-Rhythm study is 278
      subjects. Included in the enrollment ceiling are up to 20 roll-in subjects and a maximum of
      258 randomized subjects.

      The duration of the study is expected to last approximately 4 years. Enrollment is expected
      to take approximately 24 months. The duration of individual subject participation is expected
      to last approximately 2 years but may vary per subject.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Treatment Arm - PVI, LAA Isolation and WATCHMAN LAAC Implantation Control Arm - PVI
primary purpose: Treatment
masking: None (Open Label)
measure: Freedom from AF
time frame: 12 months
description: Not having any of the following after the blanking period:
a documented symptomatic AF event (episode of 30 sec duration or longer by Holter, event monitor or rhythm strip; or for the full 10 second recording of a standard 12 lead ECG)
treatment with a Class I or Class III AAD
a documented symptomatic AF event (episode of 30 sec duration or longer by Holter, event monitor or rhythm strip; or for the full 10 second recording of a standard 12 lead ECG)
treatment with a Class I or Class III AAD
arm group label: Test Group
arm group type: Experimental
description: The test group will receive Pulmonary Vein Isolation, LAA Isolation and LAA Occlusion with the WATCHMAN LAAC Device
arm group label: Control Group
arm group type: Active Comparator
description: The control group will receive Pulmonary Vein Isolation
intervention type: Device
intervention name: Pulmonary Vein Isolation
description: Pulmonary Vein Isolation by RF Ablation
arm group label: Control Group
arm group label: Test Group
intervention type: Device
intervention name: LAA Isolation
description: LAA Isolation by RF Ablation
arm group label: Test Group
intervention type: Device
intervention name: LAA Occlusion
description: LAA Occlusion by implantation of the WATCHMAN LAAC Device
arm group label: Test Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Atrial Fibrillation