<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/NCT02213666</url>
  </required_header>
  <id_info>
    <org_study_id>2011P000387</org_study_id>
    <nct_id>NCT02213666</nct_id>
  </id_info>
  <brief_title>Comparison of Intracardiac Echocardiography and Transesophageal Echocardiography</brief_title>
  <acronym>ICE-TEE</acronym>
  <official_title>Comparison of Intracardiac Echocardiography and Transesophageal Echocardiography for Imaging of the Left Atrial Appendage and Right Atrial Appendage in Patients With Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Elad Anter</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biosense Webster, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The presence of intracardiac thrombi and their propensity for systemic embolism is a major&#xD;
      concern in patients with atrial fibrillation (AF) and atrial flutter (AFL) undergoing&#xD;
      cardioversion and ablation procedures. Transesophageal echocardiography (TEE) is the clinical&#xD;
      gold standard imaging modality for visualization of the right atrial appendage (RAA) and left&#xD;
      atrial appendage (LAA) for detection of thrombi as well as risk factors associated with&#xD;
      thrombus formation, including spontaneous echo contrast and low LAA velocity. However, TEE is&#xD;
      a moderately invasive procedure that incurs additional risk, cost, and patient discomfort. In&#xD;
      addition, thrombus detection via TEE may be ambiguous, and another tool capable of confirming&#xD;
      uncertain TEE findings is desirable. This is particularly crucial in cases when adequate LAA&#xD;
      imaging cannot be acquired or if TEE is clinically contraindicated, requiring alternative&#xD;
      imaging modalities that can visualize these structures.&#xD;
&#xD;
      Phased-array intracardiac echocardiography (ICE) provides high-imaging resolution and is&#xD;
      routinely used during atrial fibrillation (AF) ablation procedures for transseptal puncture&#xD;
      and periprocedural catheter visualization. A majority of imaging acquired during AF ablation&#xD;
      is performed with the ICE catheter in the right atrium (RA). However, these standard views&#xD;
      are often unable to provide sufficient visualization of the LAA structure due to the&#xD;
      relatively long distance between the ICE catheter and LAA.&#xD;
&#xD;
      Placement of the ICE catheter in the pulmonary artery (PA) provides improved visualization of&#xD;
      the LAA over other locations by reducing the anatomic distance between the imaging catheter&#xD;
      and structure of interest. Recent retrospective studies have confirmed improved assessment of&#xD;
      the LAA with ICE imaging from the PA and equivocal sensitivity and specificity when compared&#xD;
      with TEE for evaluation of LAA thrombus. However, these studies did not systematically&#xD;
      evaluate the presence of SEC, flow velocity, the LAA dimensions, or the RAA.&#xD;
&#xD;
      Although these studies support the use of ICE imaging from the PA to clarify or confirm TEE&#xD;
      findings, a prospective and blinded study evaluating both the LAA and RAA in its entirety is&#xD;
      required. We hypothesize that this prospective and blinded study will confirm ICE as&#xD;
      non-inferior to TEE in the assessment of LAA and RAA structure and for the detection of&#xD;
      thrombi.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Transesophageal echocardiography (TEE) is the clinical standard for diagnosis of left atrial&#xD;
      appendage (LAA) and right atrial appendage (RAA) thrombi before cardioversion or&#xD;
      instrumentation of the left atrium during ablation proce- dures.1-5 Occasionally, TEE cannot&#xD;
      be performed because of anatomic limitations requiring an alternative imaging strategy to&#xD;
      exclude LAA thrombi. Phased-array intracardiac echocardiography (ICE) is routinely used&#xD;
      during atrial fibrillation (AF) ablation procedures to guide transseptal puncture and detect&#xD;
      complications. The standard position of the transducer is in the right atrium (RA). This&#xD;
      allows adequate visualization of the interatrial septum and body of the left atrium (LA) but&#xD;
      not of the LAA because of significant physical distance from the transducer. Imaging of the&#xD;
      LAA from closer anatomic structures such as the right ventricular outflow tract (RVOT) and&#xD;
      pulmonary artery (PA) can improve visualization of the LAA. If ICE provided imaging of the&#xD;
      LAA comparable to TEE with a good safety profile, it could potentially serve as an&#xD;
      alternative to TEE in patients undergoing catheter ablation. Such an approach could reduce&#xD;
      risk, cost, and patient discomfort associated with TEE combined with ICE. In this prospective&#xD;
      blinded study, we sought to directly compare the sensitivity and specificity of TEE with ICE&#xD;
      for detection of LAA and RAA anatomy and thrombus in patients with atrial tachyarrhythmias&#xD;
      undergoing catheter ablation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Intracardiac and Transesophageal Echo Results</measure>
    <time_frame>Time of Clinical Procedure Only (Average 6 hours)</time_frame>
    <description>The right atrial appendage (RAA) and left atrial appendage (LAA) will be assessed for the presence or absence of intracardiac thrombi with the Siemens AcuNav Ultrasound catheter. This is also performed with the standard of care modality, transesophageal echocardiography (TEE) with both operators blinded to the opposing imaging modality. The presence of LAA thrombi requires cancellation of the clinical procedure. After a determination has been made by both operators regarding the presence or absence of thrombi will investigators be unblinded to the opposing imaging modality result. If intracardiac thrombi was detected, the procedure was cancelled according to standard clinical guidelines and practice. There is no follow-up data collected. Participants were followed during enrollment and the clinical ablation procedure which is an average of a 6 hour period.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">72</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Atrial Flutter</condition>
  <arm_group>
    <arm_group_label>Intracardiac and Transesophageal Echocardiography</arm_group_label>
    <description>Imaging of the right atrial appendage and left atrial appendage with ICE and TEE</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intracardiac Imaging</intervention_name>
    <description>Imaging of the RAA and LAA with ICE and assessment of thrombus.</description>
    <arm_group_label>Intracardiac and Transesophageal Echocardiography</arm_group_label>
    <other_name>Siemens AcuNav 8 French Phased Array Intracardiac Ultrasound Catheter</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with drug-refractory, symptomatic, paroxysmal or persistent atrial fibrillation or&#xD;
        atrial flutter requiring a clinical indicated ablation procedure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients able to understand and critically review the informed consent.&#xD;
&#xD;
          -  Patients presenting for an AF and/or AFL ablation procedure who have clinical&#xD;
             indication for TEE and ICE.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in whom placement of an ICE catheter for adequate atrial visualization is&#xD;
             technically not feasible.&#xD;
&#xD;
          -  Patients requiring urgent cardioversion.&#xD;
&#xD;
          -  Patients with a contraindication for TEE&#xD;
&#xD;
          -  Inability to give informed consent.&#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>Elad Anter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cory M Tschabrunn, CEPS</last_name>
    <role>Study Director</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <results_first_submitted>January 14, 2016</results_first_submitted>
  <results_first_submitted_qc>March 23, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 3, 2017</results_first_posted>
  <last_update_submitted>March 23, 2017</last_update_submitted>
  <last_update_submitted_qc>March 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Elad Anter</investigator_full_name>
    <investigator_title>Attending Physician, Cardiac Electrophysiology</investigator_title>
  </responsible_party>
  <keyword>Atrial fibrillation ablation</keyword>
  <keyword>Intracardiac echocardiography</keyword>
  <keyword>Thrombus</keyword>
  <keyword>Left atrial appendage</keyword>
  <keyword>Right atrial appendage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Atrial Flutter</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Patients were interviewed in the pre-procedure room on the day of the planned procedure after consenting for the planned clinical procedure. A Co-Investigator introduced and discussed the study with the patient in detail, provided the consent form to review and addressed any questions.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Intracardiac and Transesophageal Echocardiography</title>
          <description>The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Patients enrolled into study that underwent ICE and TEE imaging.</population>
      <group_list>
        <group group_id="B1">
          <title>Enrolled Patients</title>
          <description>The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="72"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Intracardiac and Transesophageal Echo Results</title>
        <description>The right atrial appendage (RAA) and left atrial appendage (LAA) will be assessed for the presence or absence of intracardiac thrombi with the Siemens AcuNav Ultrasound catheter. This is also performed with the standard of care modality, transesophageal echocardiography (TEE) with both operators blinded to the opposing imaging modality. The presence of LAA thrombi requires cancellation of the clinical procedure. After a determination has been made by both operators regarding the presence or absence of thrombi will investigators be unblinded to the opposing imaging modality result. If intracardiac thrombi was detected, the procedure was cancelled according to standard clinical guidelines and practice. There is no follow-up data collected. Participants were followed during enrollment and the clinical ablation procedure which is an average of a 6 hour period.</description>
        <time_frame>Time of Clinical Procedure Only (Average 6 hours)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Enrolled Patients</title>
            <description>The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.</description>
          </group>
        </group_list>
        <measure>
          <title>Intracardiac and Transesophageal Echo Results</title>
          <description>The right atrial appendage (RAA) and left atrial appendage (LAA) will be assessed for the presence or absence of intracardiac thrombi with the Siemens AcuNav Ultrasound catheter. This is also performed with the standard of care modality, transesophageal echocardiography (TEE) with both operators blinded to the opposing imaging modality. The presence of LAA thrombi requires cancellation of the clinical procedure. After a determination has been made by both operators regarding the presence or absence of thrombi will investigators be unblinded to the opposing imaging modality result. If intracardiac thrombi was detected, the procedure was cancelled according to standard clinical guidelines and practice. There is no follow-up data collected. Participants were followed during enrollment and the clinical ablation procedure which is an average of a 6 hour period.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Intracardiac Echo Completed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEE Completed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Cases of Definite Thrombi Identified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEE Diagnostic in Identification of Thrombi</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ICE Diagnostic in Identification of Thrombi</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During enrollment, the clinical ablation procedure, while in the hospital.</time_frame>
      <desc>All patients were screened for any complications at the conclusion of the clinical procedure (average of 6 hour period).</desc>
      <group_list>
        <group group_id="E1">
          <title>Enrolled Patients</title>
          <description>The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal bleeding from TEE</sub_title>
                <description>2 patients developed oropharyngeal bleeding from the TEE probe - this is a known complication associated with TEE imaging and not associated with participation in the study. This resolved spontaneously without further consequence or intervention.</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="71"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This study compared TEE and ICE for visualization of the LAA and RAA in a specific patient population with nonvalvular AF treated with chronic anti-coagulation. The utility of ICE in other patient populations has not been examined.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Elad Anter, MD</name_or_title>
      <organization>Beth Israel Deaconess Medical Center</organization>
      <phone>617-632-9209</phone>
      <email>eanter@bidmc.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02213666
org study id: 2011P000387
nct id: NCT02213666
lead sponsor: 
collaborator: 
has dmc: No
The presence of intracardiac thrombi and their propensity for systemic embolism is a major
      concern in patients with atrial fibrillation (AF) and atrial flutter (AFL) undergoing
      cardioversion and ablation procedures. Transesophageal echocardiography (TEE) is the clinical
      gold standard imaging modality for visualization of the right atrial appendage (RAA) and left
      atrial appendage (LAA) for detection of thrombi as well as risk factors associated with
      thrombus formation, including spontaneous echo contrast and low LAA velocity. However, TEE is
      a moderately invasive procedure that incurs additional risk, cost, and patient discomfort. In
      addition, thrombus detection via TEE may be ambiguous, and another tool capable of confirming
      uncertain TEE findings is desirable. This is particularly crucial in cases when adequate LAA
      imaging cannot be acquired or if TEE is clinically contraindicated, requiring alternative
      imaging modalities that can visualize these structures.

      Phased-array intracardiac echocardiography (ICE) provides high-imaging resolution and is
      routinely used during atrial fibrillation (AF) ablation procedures for transseptal puncture
      and periprocedural catheter visualization. A majority of imaging acquired during AF ablation
      is performed with the ICE catheter in the right atrium (RA). However, these standard views
      are often unable to provide sufficient visualization of the LAA structure due to the
      relatively long distance between the ICE catheter and LAA.

      Placement of the ICE catheter in the pulmonary artery (PA) provides improved visualization of
      the LAA over other locations by reducing the anatomic distance between the imaging catheter
      and structure of interest. Recent retrospective studies have confirmed improved assessment of
      the LAA with ICE imaging from the PA and equivocal sensitivity and specificity when compared
      with TEE for evaluation of LAA thrombus. However, these studies did not systematically
      evaluate the presence of SEC, flow velocity, the LAA dimensions, or the RAA.

      Although these studies support the use of ICE imaging from the PA to clarify or confirm TEE
      findings, a prospective and blinded study evaluating both the LAA and RAA in its entirety is
      required. We hypothesize that this prospective and blinded study will confirm ICE as
      non-inferior to TEE in the assessment of LAA and RAA structure and for the detection of
      thrombi.
Transesophageal echocardiography (TEE) is the clinical standard for diagnosis of left atrial
      appendage (LAA) and right atrial appendage (RAA) thrombi before cardioversion or
      instrumentation of the left atrium during ablation proce- dures.1-5 Occasionally, TEE cannot
      be performed because of anatomic limitations requiring an alternative imaging strategy to
      exclude LAA thrombi. Phased-array intracardiac echocardiography (ICE) is routinely used
      during atrial fibrillation (AF) ablation procedures to guide transseptal puncture and detect
      complications. The standard position of the transducer is in the right atrium (RA). This
      allows adequate visualization of the interatrial septum and body of the left atrium (LA) but
      not of the LAA because of significant physical distance from the transducer. Imaging of the
      LAA from closer anatomic structures such as the right ventricular outflow tract (RVOT) and
      pulmonary artery (PA) can improve visualization of the LAA. If ICE provided imaging of the
      LAA comparable to TEE with a good safety profile, it could potentially serve as an
      alternative to TEE in patients undergoing catheter ablation. Such an approach could reduce
      risk, cost, and patient discomfort associated with TEE combined with ICE. In this prospective
      blinded study, we sought to directly compare the sensitivity and specificity of TEE with ICE
      for detection of LAA and RAA anatomy and thrombus in patients with atrial tachyarrhythmias
      undergoing catheter ablation.
observational model: Case-Only
time perspective: Prospective
measure: Intracardiac and Transesophageal Echo Results
time frame: Time of Clinical Procedure Only (Average 6 hours)
description: The right atrial appendage (RAA) and left atrial appendage (LAA) will be assessed for the presence or absence of intracardiac thrombi with the Siemens AcuNav Ultrasound catheter. This is also performed with the standard of care modality, transesophageal echocardiography (TEE) with both operators blinded to the opposing imaging modality. The presence of LAA thrombi requires cancellation of the clinical procedure. After a determination has been made by both operators regarding the presence or absence of thrombi will investigators be unblinded to the opposing imaging modality result. If intracardiac thrombi was detected, the procedure was cancelled according to standard clinical guidelines and practice. There is no follow-up data collected. Participants were followed during enrollment and the clinical ablation procedure which is an average of a 6 hour period.
arm group label: Intracardiac and Transesophageal Echocardiography
description: Imaging of the right atrial appendage and left atrial appendage with ICE and TEE
intervention type: Device
intervention name: Intracardiac Imaging
description: Imaging of the RAA and LAA with ICE and assessment of thrombus.
arm group label: Intracardiac and Transesophageal Echocardiography
other name: Siemens AcuNav 8 French Phased Array Intracardiac Ultrasound Catheter
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elad Anter, MD
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center
last name: Cory M Tschabrunn, CEPS
role: Study Director
affiliation: Beth Israel Deaconess Medical Center
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Elad Anter
investigator title: Attending Physician, Cardiac Electrophysiology
mesh term: Atrial Fibrillation
mesh term: Atrial Flutter
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study compared TEE and ICE for visualization of the LAA and RAA in a specific patient population with nonvalvular AF treated with chronic anti-coagulation. The utility of ICE in other patient populations has not been examined.
point of contact: 