xml: <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/NCT06007872</url>
    </required_header>
    <id_info>
      <org_study_id>22-1084</org_study_id>
      <nct_id>NCT06007872</nct_id>
    </id_info>
    <brief_title>Intracardiac Echocardiography Guided Watchman Device Implant</brief_title>
    <official_title>Feasibility: Intracardiac Echocardiography Guided Watchman Device Implant</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Cleveland Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Cleveland Clinic</source>
    <oversight_info>
      <has_dmc>No</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>
        This study is to look at the success of Intracardiac Echocardiography (ICE) in the Watchman&#xD;
        procedure. Currently the process is to use a Transesophageal Echocardiography (TEE) to place&#xD;
        the Watchman in patients. This study is aiming to show how the ICE is just as effective in&#xD;
        placing the device correctly and effectively.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Left atrial appendage occlusion is approved as an indicated therapy for patients with non&#xD;
        valvular atrial fibrillation, high risk of stroke and an appropriate rationale for avoidance&#xD;
        of long term use of oral anticoagulants.&#xD;
  &#xD;
        Concurrent procedural TEE is an integral part of the procedure. It is used to guide&#xD;
        trans-septal puncture, device sizing and assessment of final adequacy of device implant.&#xD;
  &#xD;
        TEE requires the participation and guidance of a cardiac imager and because the TEE probe is&#xD;
        in place for a relatively long duration the procedure, the procedure is most commonly&#xD;
        performed under general anesthesia. Furthermore TEE can be associated with risk of injury to&#xD;
        the oropharynx and esophagus. Our ongoing clinical experience and known literature suggest&#xD;
        that TEE may not be necessary for the overall success of the procedure. The objective of the&#xD;
        study is to investigate a new work flow that may ultimately demonstrate that intra-procedural&#xD;
        TEE may not be necessary, obviating the need for additional personnel, general anesthesia and&#xD;
        decreasing overall risk. ICE has been widely used to aid trans-septal puncture and visualize&#xD;
        left atrial anatomy. Smaller studies and case series have reported the use of ICE as an&#xD;
        alternative to TEE in guiding Watchman device implant. This has not been compared&#xD;
        systematically with TEE in a large patient sample.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 2, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Successful Watchman implantation using intracardiac echocardiography (ICE) guidance</measure>
      <time_frame>During the procedure</time_frame>
      <description>Intracardiac echocardiography (ICE) guided Watchman placement confirmed by transesophageal echocardiography (TEE)</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Atrial Fibrillation</condition>
    <condition>Left Atrial Appendage Thrombosis</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intracardiac Echocardiography (ICE)</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Intracardiac Echocardiography (ICE)</intervention_name>
      <description>ICE will be used to guide trans-septal puncture and to guide device implant.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients who meet guideline established criteria for commercially available&#xD;
               Watchman device implant and not enrolled in an active clinical trial&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients in whom a procedural TEE cannot be performed and an ICE only implant is&#xD;
               needed.&#xD;
  &#xD;
            -  Patients receiving a concomitant ablation procedure&#xD;
  &#xD;
            -  Patients with prior incomplete surgical or percutaneous left atrial appendage&#xD;
               ligation/exclusion procedures&#xD;
  &#xD;
            -  Patients in whom the delivery of trans-septal equipment is anticipated to be difficult&#xD;
               (e.g. patent foramen ovale (PFO) or atrial septal defect (ASD) closure devices in&#xD;
               place).&#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>Shady Nakhla, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Cleveland Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shady Nakhla, MD</last_name>
      <phone>216-445-9474</phone>
      <email>NAKHLAS@ccf.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Cleveland Clinic</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44195</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Shady Nahkla, MD</last_name>
        <phone>216-445-9474</phone>
        <email>NAKHLAS@ccf.org</email>
      </contact>
      <investigator>
        <last_name>Oussama Wazni, MD, MBA</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Walid Saliba, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Mohamed Kanj, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Tyler Taigen, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Serge Harb, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Rhonda Miyasaka, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Samir Kapadia, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
      <investigator_full_name>Shady Nakhla, MD</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atrial Fibrillation</mesh_term>
      <mesh_term>Thrombosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06007872
  org study id: 22-1084
  nct id: NCT06007872
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  This study is to look at the success of Intracardiac Echocardiography (ICE) in the Watchman
        procedure. Currently the process is to use a Transesophageal Echocardiography (TEE) to place
        the Watchman in patients. This study is aiming to show how the ICE is just as effective in
        placing the device correctly and effectively.
  Left atrial appendage occlusion is approved as an indicated therapy for patients with non
        valvular atrial fibrillation, high risk of stroke and an appropriate rationale for avoidance
        of long term use of oral anticoagulants.
  
        Concurrent procedural TEE is an integral part of the procedure. It is used to guide
        trans-septal puncture, device sizing and assessment of final adequacy of device implant.
  
        TEE requires the participation and guidance of a cardiac imager and because the TEE probe is
        in place for a relatively long duration the procedure, the procedure is most commonly
        performed under general anesthesia. Furthermore TEE can be associated with risk of injury to
        the oropharynx and esophagus. Our ongoing clinical experience and known literature suggest
        that TEE may not be necessary for the overall success of the procedure. The objective of the
        study is to investigate a new work flow that may ultimately demonstrate that intra-procedural
        TEE may not be necessary, obviating the need for additional personnel, general anesthesia and
        decreasing overall risk. ICE has been widely used to aid trans-septal puncture and visualize
        left atrial anatomy. Smaller studies and case series have reported the use of ICE as an
        alternative to TEE in guiding Watchman device implant. This has not been compared
        systematically with TEE in a large patient sample.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Successful Watchman implantation using intracardiac echocardiography (ICE) guidance
  time frame: During the procedure
  description: Intracardiac echocardiography (ICE) guided Watchman placement confirmed by transesophageal echocardiography (TEE)
  arm group label: Intervention
  arm group type: Experimental
  description: Intracardiac Echocardiography (ICE)
  intervention type: Device
  intervention name: Intracardiac Echocardiography (ICE)
  description: ICE will be used to guide trans-septal puncture and to guide device implant.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Shady Nakhla, MD
  role: Principal Investigator
  affiliation: The Cleveland Clinic
  last name: Shady Nakhla, MD
  phone: 216-445-9474
  email: NAKHLAS@ccf.org
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The Cleveland Clinic
  investigator full name: Shady Nakhla, MD
  investigator title: Principal Investigator
  mesh term: Atrial Fibrillation
  mesh term: Thrombosis
  sharing ipd: No