<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/NCT03261973</url>
  </required_header>
  <id_info>
    <org_study_id>2017P001544</org_study_id>
    <nct_id>NCT03261973</nct_id>
  </id_info>
  <brief_title>Esophageal Deviation in Atrial Fibrillation Ablation</brief_title>
  <official_title>Esophageal Deviation in Atrial Fibrillation Ablation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Catheter ablation with pulmonary vein (PV) isolation is a commonly performed strategy&#xD;
      employed for the treatment of atrial fibrillation (AF). However, ablation in the posterior&#xD;
      wall of the left atrium can cause thermal injury to the esophagus. Thermal injury is very&#xD;
      common and occurs in up to 40% of AF ablations per some studies. When significant thermal&#xD;
      injury to the esophagus occurs, two significant complications can arise: 1) the formation of&#xD;
      an atrio-esophageal fistula, and 2) gastrointestinal dysmotility. While the occurrence of&#xD;
      fistula is rare, it is a very important complication since it is often fatal. Currently&#xD;
      luminal esophageal temperature monitoring is the most commonly employed modality to prevent&#xD;
      such injury. However, there are limitations to its use, and atrio-esophageal fistulas&#xD;
      continue to be a major problem in AF ablation even when using esophageal temperature&#xD;
      monitoring. Esophageal deviation using either a Transesophageal echocardiogram (TEE) or&#xD;
      Esophagogastroduodenoscopy (EGD) probe has been described in the literature, but the&#xD;
      effectiveness and practicality of these techniques are suboptimal, and have therefore&#xD;
      precluded their use in routine clinical practice. Recently, esophageal deviation using&#xD;
      off-the-shelf equipment (a soft thoracic tube and endotracheal stylet) was tested in the&#xD;
      randomized double-blind multicenter study &quot;Deviating the Esophagus in Atrial Fibrillation&#xD;
      Ablation (DEVIATE-AF)&quot;. In that study the standard practice (i.e., use of luminal esophageal&#xD;
      temperature monitoring) was compared to esophageal deviation using off-the-shelf equipment.&#xD;
      The results were very encouraging showing that esophageal deviation allowed for significant&#xD;
      reductions in esophageal temperature and proportion of premature ablation terminations.&#xD;
      Importantly, esophageal deviation allowed the isolation all PVs in the treatment group, which&#xD;
      was not the case in the control group. One major limitation in the DEVIATE-AF trial was that&#xD;
      off-the-shelf equipment tool was challenging to use. The aim of the Esophageal Deviation in&#xD;
      Atrial Fibrillation Ablation study is to test the feasibility and safety of moving the&#xD;
      esophagus using a specialized esophageal deviation tool (DV8, Manual Surgical Sciences,&#xD;
      Minneapolis, MN).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 17, 2017</start_date>
  <completion_date type="Actual">June 15, 2020</completion_date>
  <primary_completion_date type="Actual">June 15, 2020</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With a Minimum Distance of 1 cm Esophageal Deviation Between the Ablation Line for the Ipsilateral Pulmonary Vein (PV) Pairs and the Trailing Edge of the Esophagus.</measure>
    <time_frame>during Atrial Fibrillation (AF) ablation procedure (intraoperative)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Average Distance of 2 cm Esophageal Deviation From the Ablation Line for the Ipsilateral PV Pairs.</measure>
    <time_frame>during AF ablation procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced Esophageal Laceration</measure>
    <time_frame>within 1-90 days of the procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With PV Reconnection Assessed by Adenosine Infusion</measure>
    <time_frame>during AF ablation procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy Time Measured for the Whole Procedure</measure>
    <time_frame>during AF ablation procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure Duration Measured From the Initial Groin Stick to Catheter Removal</measure>
    <time_frame>during the AF ablation procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ablation Time Assessed by the Total Duration of Radiofrequency Energy Delivery</measure>
    <time_frame>during the AF ablation procedure</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>DV8 esophageal deviation tool</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This is a non-randomized one arm study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DV8</intervention_name>
    <description>DV8 esophageal deviation tool</description>
    <arm_group_label>DV8 esophageal deviation tool</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA&#xD;
&#xD;
          -  A maximum of up to 54 patients will be enrolled in this prospective single-center&#xD;
             single-arm study. Patients undergoing AF ablation (including paroxysmal and persistent&#xD;
             AF) will be included in this study. Consistent with the current definitions,&#xD;
             paroxysmal AF are episodes that will self-terminate in less than 24 hours. Persistent&#xD;
             AF, is defined as ≥1 documented AF lasting &gt;1week in duration or lasting less than 7&#xD;
             days but requiring electrical or pharmacological cardioversion to sinus rhythm.&#xD;
&#xD;
          -  Age &gt;18 - Age &lt; 80 yr&#xD;
&#xD;
          -  Documentation of atrial fibrillation (AF)&#xD;
&#xD;
          -  General anesthesia&#xD;
&#xD;
          -  All patients must understand and adhere to the requirements of the study and be&#xD;
             willing to comply with the post study follow-up requirements.&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
          -  Any reversible cause of AF (post-surgery, thyroid disorder, etc.)&#xD;
&#xD;
          -  INR (international normalized ratio) &gt; 4.0 at the time of the procedure&#xD;
&#xD;
          -  History of (H/o) of severe esophageal ulcers, strictures, varices, bleeding,&#xD;
             laceration or perforation, esophagitis&#xD;
&#xD;
          -  Severe Gastroesophageal Reflux Disease (GERD)&#xD;
&#xD;
          -  H/o esophageal surgery or any esophageal banding or cautery&#xD;
&#xD;
          -  H/o chest radiation&#xD;
&#xD;
          -  Significant abnormality on Swallowing Impairment Score&#xD;
&#xD;
          -  Mental impairment precluding signing consent or completing follow up&#xD;
&#xD;
          -  Patients with any other significant uncontrolled or unstable medical condition&#xD;
&#xD;
          -  Women who are known to be pregnant or have had a positive β-HCG (Human Chorionic&#xD;
             Gonadotropin) test within 7 days prior to procedure&#xD;
&#xD;
          -  Presence of left atrial thrombus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <results_first_submitted>May 25, 2021</results_first_submitted>
  <results_first_submitted_qc>June 28, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 30, 2021</results_first_posted>
  <last_update_submitted>June 28, 2021</last_update_submitted>
  <last_update_submitted_qc>June 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Moussa C Mansour</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>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03261973/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>DV8 Esophageal Deviation Tool</title>
          <description>This is a non-randomized one arm study.&#xD;
Arm: usage of the DV8 esophageal deviation tool during the ablation procedure</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>DV8 Esophageal Deviation Tool</title>
          <description>This is a non-randomized one arm study.&#xD;
Arm: usage of the DV8 esophageal deviation tool during the ablation procedure</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.9" spread="9.1"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With a Minimum Distance of 1 cm Esophageal Deviation Between the Ablation Line for the Ipsilateral Pulmonary Vein (PV) Pairs and the Trailing Edge of the Esophagus.</title>
        <time_frame>during Atrial Fibrillation (AF) ablation procedure (intraoperative)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DV8 Esophageal Deviation Tool</title>
            <description>This is a non-randomized one arm study.&#xD;
Arm: usage of the DV8 esophageal deviation tool during the ablation procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Minimum Distance of 1 cm Esophageal Deviation Between the Ablation Line for the Ipsilateral Pulmonary Vein (PV) Pairs and the Trailing Edge of the Esophagus.</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Average Distance of 2 cm Esophageal Deviation From the Ablation Line for the Ipsilateral PV Pairs.</title>
        <time_frame>during AF ablation procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DV8 Esophageal Deviation Tool</title>
            <description>This is a non-randomized one arm study.&#xD;
Arm: usage of the DV8 esophageal deviation tool during the ablation procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Average Distance of 2 cm Esophageal Deviation From the Ablation Line for the Ipsilateral PV Pairs.</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced Esophageal Laceration</title>
        <time_frame>within 1-90 days of the procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DV8 Esophageal Deviation Tool</title>
            <description>This is a non-randomized one arm study.&#xD;
Arm: usage of the DV8 esophageal deviation tool during the ablation procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced Esophageal Laceration</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With PV Reconnection Assessed by Adenosine Infusion</title>
        <time_frame>during AF ablation procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DV8 Esophageal Deviation Tool</title>
            <description>This is a non-randomized one arm study.&#xD;
Arm: usage of the DV8 esophageal deviation tool during the ablation procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With PV Reconnection Assessed by Adenosine Infusion</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fluoroscopy Time Measured for the Whole Procedure</title>
        <time_frame>during AF ablation procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DV8 Esophageal Deviation Tool</title>
            <description>This is a non-randomized one arm study.&#xD;
Arm: usage of the DV8 esophageal deviation tool during the ablation procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Fluoroscopy Time Measured for the Whole Procedure</title>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.8" spread="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Procedure Duration Measured From the Initial Groin Stick to Catheter Removal</title>
        <time_frame>during the AF ablation procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DV8 Esophageal Deviation Tool</title>
            <description>This is a non-randomized one arm study.&#xD;
Arm: usage of the DV8 esophageal deviation tool during the ablation procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Procedure Duration Measured From the Initial Groin Stick to Catheter Removal</title>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="212" spread="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ablation Time Assessed by the Total Duration of Radiofrequency Energy Delivery</title>
        <time_frame>during the AF ablation procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DV8 Esophageal Deviation Tool</title>
            <description>This is a non-randomized one arm study.&#xD;
Arm: usage of the DV8 esophageal deviation tool during the ablation procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Ablation Time Assessed by the Total Duration of Radiofrequency Energy Delivery</title>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.2" spread="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The duration of the study was 3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>DV8 Esophageal Deviation Tool</title>
          <description>This is a non-randomized one arm study.&#xD;
Arm: usage of the DV8 esophageal deviation tool during the ablation procedure</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastroparesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="43"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <point_of_contact>
      <name_or_title>Grace Ha</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>617-643-1697</phone>
      <email>gha2@mgh.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/NCT03261973
org study id: 2017P001544
nct id: NCT03261973
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
Catheter ablation with pulmonary vein (PV) isolation is a commonly performed strategy
      employed for the treatment of atrial fibrillation (AF). However, ablation in the posterior
      wall of the left atrium can cause thermal injury to the esophagus. Thermal injury is very
      common and occurs in up to 40% of AF ablations per some studies. When significant thermal
      injury to the esophagus occurs, two significant complications can arise: 1) the formation of
      an atrio-esophageal fistula, and 2) gastrointestinal dysmotility. While the occurrence of
      fistula is rare, it is a very important complication since it is often fatal. Currently
      luminal esophageal temperature monitoring is the most commonly employed modality to prevent
      such injury. However, there are limitations to its use, and atrio-esophageal fistulas
      continue to be a major problem in AF ablation even when using esophageal temperature
      monitoring. Esophageal deviation using either a Transesophageal echocardiogram (TEE) or
      Esophagogastroduodenoscopy (EGD) probe has been described in the literature, but the
      effectiveness and practicality of these techniques are suboptimal, and have therefore
      precluded their use in routine clinical practice. Recently, esophageal deviation using
      off-the-shelf equipment (a soft thoracic tube and endotracheal stylet) was tested in the
      randomized double-blind multicenter study "Deviating the Esophagus in Atrial Fibrillation
      Ablation (DEVIATE-AF)". In that study the standard practice (i.e., use of luminal esophageal
      temperature monitoring) was compared to esophageal deviation using off-the-shelf equipment.
      The results were very encouraging showing that esophageal deviation allowed for significant
      reductions in esophageal temperature and proportion of premature ablation terminations.
      Importantly, esophageal deviation allowed the isolation all PVs in the treatment group, which
      was not the case in the control group. One major limitation in the DEVIATE-AF trial was that
      off-the-shelf equipment tool was challenging to use. The aim of the Esophageal Deviation in
      Atrial Fibrillation Ablation study is to test the feasibility and safety of moving the
      esophagus using a specialized esophageal deviation tool (DV8, Manual Surgical Sciences,
      Minneapolis, MN).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Participants With a Minimum Distance of 1 cm Esophageal Deviation Between the Ablation Line for the Ipsilateral Pulmonary Vein (PV) Pairs and the Trailing Edge of the Esophagus.
time frame: during Atrial Fibrillation (AF) ablation procedure (intraoperative)
measure: Number of Participants With an Average Distance of 2 cm Esophageal Deviation From the Ablation Line for the Ipsilateral PV Pairs.
time frame: during AF ablation procedure
measure: Number of Participants Who Experienced Esophageal Laceration
time frame: within 1-90 days of the procedure
measure: Number of Participants With PV Reconnection Assessed by Adenosine Infusion
time frame: during AF ablation procedure
measure: Fluoroscopy Time Measured for the Whole Procedure
time frame: during AF ablation procedure
measure: Procedure Duration Measured From the Initial Groin Stick to Catheter Removal
time frame: during the AF ablation procedure
measure: Ablation Time Assessed by the Total Duration of Radiofrequency Energy Delivery
time frame: during the AF ablation procedure
arm group label: DV8 esophageal deviation tool
arm group type: Other
description: This is a non-randomized one arm study.
intervention type: Device
intervention name: DV8
description: DV8 esophageal deviation tool
arm group label: DV8 esophageal deviation tool
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Moussa C Mansour
investigator title: Principal Investigator
mesh term: Atrial Fibrillation
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 