<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/NCT03302494</url>
  </required_header>
  <id_info>
    <org_study_id>CHX_IP014</org_study_id>
    <nct_id>NCT03302494</nct_id>
  </id_info>
  <brief_title>WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2</brief_title>
  <acronym>WAVECREST2</acronym>
  <official_title>WAveCrest Vs. Watchman TranssEptal LAA Closure to REduce AF-Mediated STroke 2. A Prospective, Multicenter, Randomized, Active Controlled, Clinical Trial of the Coherex WaveCrest® Left Atrial Appendage Occlusion System Compared to the Watchman® LAA Closure Device for the Reduction in Risk of Ischemic Stroke or Systemic Embolism in Subjects With Non-valvular Atrial Fibrillation That Have an Appropriate Rationale to Seek a Non-pharmacologic Alternative to Chronic Oral Anticoagulation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coherex Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biosense Webster, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Coherex Medical</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 WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical&#xD;
      trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage&#xD;
      (LAA) Occlusion System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical&#xD;
      trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage&#xD;
      (LAA) Occlusion System. Subjects will be randomized in a 1:1 ratio to the Treatment Arm&#xD;
      (Coherex WaveCrest LAA occlusion system) or the Control Arm (Boston Scientific's Watchman LAA&#xD;
      occlusion system). The trial is designed to demonstrate that safety and effectiveness of the&#xD;
      WaveCrest device are non-inferior to the Watchman device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 27, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2029</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>If the subject is suspected of having a stroke since their most recent follow-up, a Neurologist blinded to subject's randomization and implanted device must evaluate the subject or otherwise provide rationale for why an in-person neurology visit and exam are unnecessary. Neurology or blinded trial personnel should also administer mRS &amp; NIHSS if there is suspicion of stroke A Clinical Events Committee, also blinded to subject's randomization, will adjudicate primary safety and effectiveness.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Procedure or device related complications</measure>
    <time_frame>45 Days</time_frame>
    <description>Part of the composite rate of the primary safety endpoint.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All Death</measure>
    <time_frame>24 months</time_frame>
    <description>Part of the composite rate of the primary safety endpoint.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Major Bleeding</measure>
    <time_frame>24 months</time_frame>
    <description>Part of the composite rate of the primary safety endpoint.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ischemic stroke, systemic embolism</measure>
    <time_frame>24 months</time_frame>
    <description>The primary effectiveness endpoint is a composite rate of ischemic stroke or systemic embolism at 24 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ischemic stroke, systemic embolism</measure>
    <time_frame>45 days</time_frame>
    <description>The secondary endpoint is the rate of ischemic stroke or systemic embolism with the WaveCrest device in comparison to the CHADS2 and CHA2DS2-VASc imputed risk of ischemic stroke or systemic embolism in the absence of anticoagulant therapy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1550</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>WaveCrest</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>WaveCrest left atrial appendage occluder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Watchman (control)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Watchman left atrial appendage closure device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Coherex WaveCrest® Left Atrial Appendage Occlusion System</intervention_name>
    <description>Percutaneous left atrial appendage closure</description>
    <arm_group_label>WaveCrest</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Watchman® LAA Closure Device</intervention_name>
    <description>Percutaeous left atrial appendage closure</description>
    <arm_group_label>Watchman (control)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial&#xD;
             fibrillation&#xD;
&#xD;
          2. At least 18 years of age&#xD;
&#xD;
          3. Calculated CHADS2 score ≥ 2 or CHA2DS2-VASc score ≥ 3&#xD;
&#xD;
          4. Indication for warfarin therapy with an appropriate rationale to seek a&#xD;
             non-pharmacologic alternative to chronic oral anticoagulation&#xD;
&#xD;
          5. Willing and able to comply with post-implant anticoagulation and antiplatelet regimen&#xD;
&#xD;
          6. Willing to participate in the required follow-up visits and tests&#xD;
&#xD;
          7. Subject has been informed of the nature of the trial, agrees to its provisions and has&#xD;
             provided written informed consent as approved by the IRB/EC at the site&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Atrial fibrillation (AF) due to a reversible cause (e.g. thyrotoxicosis or&#xD;
             postoperative)&#xD;
&#xD;
          2. Known contraindication and/or allergy to warfarin, nickel, aspirin, intravenous&#xD;
             contrast or P2Y12 inhibitors (clopidogrel, ticagrelor, and prasugrel), which cannot be&#xD;
             adequately pre-medicated or desensitized&#xD;
&#xD;
          3. Conditions other than AF requiring long-term anticoagulation therapy&#xD;
&#xD;
          4. Contraindications for percutaneous catheterization procedures&#xD;
&#xD;
          5. Prior surgical LAA occlusion/exclusion or implanted with LAA occlusion device, or any&#xD;
             prior attempt of such procedures&#xD;
&#xD;
          6. Prior percutaneous or surgical closure of a patent foramen ovale or atrial septal&#xD;
             defect&#xD;
&#xD;
          7. Inability or unwillingness to take oral anticoagulation for 45 days post-procedure&#xD;
&#xD;
          8. New York Heart Association (NYHA) Class IV heart failure&#xD;
&#xD;
          9. Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral&#xD;
             valve intervention, or any mechanical valve implant&#xD;
&#xD;
         10. History of symptomatic carotid, intervertebral, or intracranial artery occlusion or&#xD;
             stenosis without revascularization with the exception of known occlusion without&#xD;
             symptoms &gt; 6 months&#xD;
&#xD;
         11. Modified Rankin Scale (mRS) score ≥ 4&#xD;
&#xD;
         12. Chronic resting heart rate ≥ 110 bpm&#xD;
&#xD;
         13. Congenital cardiac anomalies requiring cardiac surgery or interventional repair&#xD;
&#xD;
         14. Stroke or transient ischemic attack (confirmed by Neurologist) within 60 days prior to&#xD;
             enrollment&#xD;
&#xD;
         15. Myocardial infarction within 60 days prior to enrollment&#xD;
&#xD;
         16. Sepsis or any infection requiring oral antibiotic therapy within 14 days or&#xD;
             intravenous antibiotic therapy within 30 days prior to enrollment&#xD;
&#xD;
         17. Surgical or interventional cardiovascular and non-cardiovascular procedure including&#xD;
             cardioversion within 30 days prior to enrollment or AF ablation within 60 days prior&#xD;
             to enrollment or any planned general surgery or interventional procedure within 90&#xD;
             days after enrollment or any planned cardiac surgery.&#xD;
&#xD;
         18. On renal replacement therapy, serum creatinine &gt; 3.0 mg/dl (265 μmol/L) or calculated&#xD;
             creatinine clearance &lt; 25 ml/minute&#xD;
&#xD;
         19. Thrombocytopenia (&lt;60,000 platelets/mm3), leucopenia (white blood cell count &lt; 3,000&#xD;
             cells/mm³), or anemia (hemoglobin concentration &lt; 10 grams/deciliter) based on blood&#xD;
             work done within 30 days prior to enrollment&#xD;
&#xD;
         20. Any medical disorder or psychiatric illness that would interfere with successful&#xD;
             completion of the trial&#xD;
&#xD;
         21. Currently participating in an investigational drug trial or another device trial that&#xD;
             has not completed the primary endpoint (trials requiring extended follow-up for&#xD;
             products that are commercially available are not considered investigational trials).&#xD;
             Concurrent enrollment in the ACC LAAO Registry is permitted.&#xD;
&#xD;
         22. Subject belongs to a vulnerable population (see definition in Appendix I: Acronyms and&#xD;
             Definitions)&#xD;
&#xD;
         23. Any condition that would reduce life expectancy to less than 2 years&#xD;
&#xD;
         24. Women of childbearing potential who are, or plan to become pregnant during the time of&#xD;
             the trial (method of assessment per physician discretion)&#xD;
&#xD;
        Echocardiographic Exclusion Criteria&#xD;
&#xD;
          1. Left ventricular ejection fraction &lt; 30%&#xD;
&#xD;
          2. Mitral valve stenosis defined as valve area &lt; 1.5cm2, mean gradient &gt; 6mmHg, or any&#xD;
             valve deformity consistent with rheumatic valvular disease&#xD;
&#xD;
          3. Aortic valve stenosis defined as valve area ≤1.0cm2 or mean gradient &gt;30mmHg&#xD;
&#xD;
          4. Circumferential pericardial effusion &gt; 10mm or symptomatic pericardial effusion&#xD;
&#xD;
          5. Evidence of intracardiac thrombus&#xD;
&#xD;
          6. Cardiac tumor or myxoma&#xD;
&#xD;
          7. Atrial septal defect that warrants closure&#xD;
&#xD;
          8. Complex atheroma in the ascending aorta or aortic arch as evidenced by mobile plaque&#xD;
&#xD;
          9. Left Atrial Appendage size and shape are unsuitable for closure with a WaveCrest or&#xD;
             Watchman device&#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>Vivek Reddy, MD</last_name>
    <role>Study Chair</role>
    <affiliation>MOUNT SINAI HOSPITAL</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gregg Stone, MD</last_name>
    <role>Study Chair</role>
    <affiliation>MOUNT SINAI HOSPITAL</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>Dignity Health Mercy Gilbert Medical Center</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Heart Institute / St. John's Health Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medstar Heart and Vascular Institute - 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>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>Piedmont Heart Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellstar Kennestone</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</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>MedStar Union Memorial Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marquette General Hospital</name>
      <address>
        <city>Marquette</city>
        <state>Michigan</state>
        <zip>49855</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Munson Medical Center</name>
      <address>
        <city>Traverse City</city>
        <state>Michigan</state>
        <zip>49684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates Research, LLC</name>
      <address>
        <city>Tupelo</city>
        <state>Mississippi</state>
        <zip>38801</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>New York University- NYU Langone Cardiac</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Pinnacle Health Cardiovascular Institute</name>
      <address>
        <city>Harrisburg</city>
        <state>Pennsylvania</state>
        <zip>17104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Cardiac Arrhythmia Research Foundation</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Scott &amp; White All Saints Medical Center</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Hospital Baylor Plano (Baylor Research Institute)</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christus Trinity Clinic Research</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Health</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent's Hospital</name>
      <address>
        <city>Sydney</city>
        <zip>2023</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT03302494
org study id: CHX_IP014
nct id: NCT03302494
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical
      trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage
      (LAA) Occlusion System.
The WAVECREST 2 trial is a prospective, multicenter, randomized, active controlled, clinical
      trial to evaluate the safety and effectiveness of the Coherex WaveCrest Left Atrial Appendage
      (LAA) Occlusion System. Subjects will be randomized in a 1:1 ratio to the Treatment Arm
      (Coherex WaveCrest LAA occlusion system) or the Control Arm (Boston Scientific's Watchman LAA
      occlusion system). The trial is designed to demonstrate that safety and effectiveness of the
      WaveCrest device are non-inferior to the Watchman device.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: If the subject is suspected of having a stroke since their most recent follow-up, a Neurologist blinded to subject's randomization and implanted device must evaluate the subject or otherwise provide rationale for why an in-person neurology visit and exam are unnecessary. Neurology or blinded trial personnel should also administer mRS & NIHSS if there is suspicion of stroke A Clinical Events Committee, also blinded to subject's randomization, will adjudicate primary safety and effectiveness.
measure: Procedure or device related complications
time frame: 45 Days
description: Part of the composite rate of the primary safety endpoint.
measure: All Death
time frame: 24 months
description: Part of the composite rate of the primary safety endpoint.
measure: Major Bleeding
time frame: 24 months
description: Part of the composite rate of the primary safety endpoint.
measure: Ischemic stroke, systemic embolism
time frame: 24 months
description: The primary effectiveness endpoint is a composite rate of ischemic stroke or systemic embolism at 24 months
measure: Ischemic stroke, systemic embolism
time frame: 45 days
description: The secondary endpoint is the rate of ischemic stroke or systemic embolism with the WaveCrest device in comparison to the CHADS2 and CHA2DS2-VASc imputed risk of ischemic stroke or systemic embolism in the absence of anticoagulant therapy
arm group label: WaveCrest
arm group type: Experimental
description: WaveCrest left atrial appendage occluder
arm group label: Watchman (control)
arm group type: Active Comparator
description: Watchman left atrial appendage closure device
intervention type: Device
intervention name: Coherex WaveCrest® Left Atrial Appendage Occlusion System
description: Percutaneous left atrial appendage closure
arm group label: WaveCrest
intervention type: Device
intervention name: Watchman® LAA Closure Device
description: Percutaeous left atrial appendage closure
arm group label: Watchman (control)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vivek Reddy, MD
role: Study Chair
affiliation: MOUNT SINAI HOSPITAL
last name: Gregg Stone, MD
role: Study Chair
affiliation: MOUNT SINAI HOSPITAL
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country: Australia
country: United States
responsible party type: Sponsor
mesh term: Stroke
sharing ipd: No