<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/NCT02998866</url>
  </required_header>
  <id_info>
    <org_study_id>PI1002BD</org_study_id>
    <nct_id>NCT02998866</nct_id>
  </id_info>
  <brief_title>Cryoballoon Pulmonary Vein Isolation Including Associated Esophageal Effects</brief_title>
  <official_title>Cryoballoon Pulmonary Vein Isolation and Associated Esophageal Effects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baylor Research Institute</source>
  <brief_summary>
    <textblock>
      To determine the correlation between rate of temperature decline and nadir cryoballoon&#xD;
      temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary&#xD;
      vein isolation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When treating atrial fibrillation and targeting various areas in the left atrium,&#xD;
      electrophysiologists have the choice to perform ablation with RF energy or cryoenergy.&#xD;
      Esophageal ulceration and in more rare cases, esophageal fistulae, are known complications of&#xD;
      this ablation procedure. Though rare (0.1-0.25% fistula rate and 15-20% esophageal ulceration&#xD;
      rate according to the most recent Heart Rhythm Society EHRA ECA consensus statement)1, the&#xD;
      investigators would very much like to understand how to completely prevent these occurrences.&#xD;
      Cryoenergy has more recently been introduced as an energy source used in the PVI procedure;&#xD;
      therefore, for this energy source, rates of esophageal ulceration are not yet well-defined.&#xD;
      Nine esophageal fistulae have occurred in the first approximately 130,000 cryoballoon&#xD;
      procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Actual">February 23, 2018</completion_date>
  <primary_completion_date type="Actual">February 23, 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Temperature Decline</measure>
    <time_frame>90 days or when complications resolve</time_frame>
    <description>I. To determine the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurements of esophagus to each pulmonary vein</measure>
    <time_frame>90 days or when complications resolve</time_frame>
    <description>II. To accurately measure the distance between the esophagus and the ostium of each pulmonary vein intra-operatively.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Create Recommendations for esophageal temperature-guided ablation</measure>
    <time_frame>90 days or when complications resolve</time_frame>
    <description>To attempt to create recommendations for esophageal temperature-guided ablation in order to increase the safety profile of cryoballoon pulmonary vein isolation (PVI) by providing one center's experience. By trending cryoballoon ablation temperatures and subsequent esophageal temperatures, data trends may emerge and be predictive for esophageal ulceration formation. These trends may include:&#xD;
Distance between esophagus and pulmonary vein in patients who developed post-ablation esophageal ulcerations&#xD;
Intra-procedure esophageal temperatures in patients who developed post-ablation esophageal ulcerations&#xD;
Intra-procedure cryoballoon temperatures in patients who developed post-ablation esophageal ulcerations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of additional Adverse Events</measure>
    <time_frame>90 days or when complications resolve</time_frame>
    <description>To associate the development of symptoms (including dysphagia, chest pain, fever, &quot;heartburn,&quot; or odynophagia) with the presence of ulcerations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Data collection on Phrenic Injury</measure>
    <time_frame>90 days or when complications resolve</time_frame>
    <description>Assess participants with abnormal imaging and/or adverse events that are related to the treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Paroxysmal Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Multi-center, prospective outcomes registry</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The study is a multi-center, prospective outcomes registry</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Esophageal Temperature-Guided Ablation</intervention_name>
    <description>Esophageal temperature-guided ablation (if esophageal temperatures drop too low during cryoablation, the physician will stop the ablation) in order to increase the safety profile of cryoballoon pulmonary vein (a vein carrying blood from the participants lungs to the left side of the participants heart known as the left atrium) isolation (PVI [means a balloon shaped catheter will be placed at the opening of each pulmonary vein and tissue will be cooled in order to create an ablation line (line of scar tissue) between the left side of the participants heart and each pulmonary vein. This is done to prevent the triggers that typically cause intermittent atrial fibrillation (known as Paroxsymal Atrial Fibrillation) by providing one center's experience.</description>
    <arm_group_label>Multi-center, prospective outcomes registry</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Recurrent, symptomatic, drug-refractory, paroxysmal atrial fibrillation with planned&#xD;
             cryoballoon pulmonary vein isolation&#xD;
&#xD;
          2. Age &gt;18 years&#xD;
&#xD;
          3. Planned AF cryoablation procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. LA diameter &gt;55mm&#xD;
&#xD;
          2. Severe LVH (LV wall ≥ 15mm)&#xD;
&#xD;
          3. LA thrombus&#xD;
&#xD;
          4. Decompensated heart failure&#xD;
&#xD;
          5. Plans for left atrial ablation lesions beyond isolation of the pulmonary veins&#xD;
&#xD;
          6. History of previous pulmonary vein isolation&#xD;
&#xD;
          7. Inability to place esophageal temperature probe or TEE probe&#xD;
&#xD;
          8. Previously documented phrenic nerve injury&#xD;
&#xD;
          9. Known esophageal pathology (complete GI history worksheet)&#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>Brian Deville, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Heart Hospital Baylor of Plano</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>February 17, 2021</last_update_submitted>
  <last_update_submitted_qc>February 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cryoballoon Pulmonary Vein Isolation</keyword>
  <keyword>Esophageal Effects</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02998866
org study id: PI1002BD
nct id: NCT02998866
lead sponsor: 
To determine the correlation between rate of temperature decline and nadir cryoballoon
      temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary
      vein isolation.
When treating atrial fibrillation and targeting various areas in the left atrium,
      electrophysiologists have the choice to perform ablation with RF energy or cryoenergy.
      Esophageal ulceration and in more rare cases, esophageal fistulae, are known complications of
      this ablation procedure. Though rare (0.1-0.25% fistula rate and 15-20% esophageal ulceration
      rate according to the most recent Heart Rhythm Society EHRA ECA consensus statement)1, the
      investigators would very much like to understand how to completely prevent these occurrences.
      Cryoenergy has more recently been introduced as an energy source used in the PVI procedure;
      therefore, for this energy source, rates of esophageal ulceration are not yet well-defined.
      Nine esophageal fistulae have occurred in the first approximately 130,000 cryoballoon
      procedures.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Temperature Decline
time frame: 90 days or when complications resolve
description: I. To determine the correlation between rate of temperature decline and nadir cryoballoon temperatures rate of temperature decline and nadir esophageal temperatures during pulmonary vein isolation procedure.
measure: Measurements of esophagus to each pulmonary vein
time frame: 90 days or when complications resolve
description: II. To accurately measure the distance between the esophagus and the ostium of each pulmonary vein intra-operatively.
measure: Create Recommendations for esophageal temperature-guided ablation
time frame: 90 days or when complications resolve
description: To attempt to create recommendations for esophageal temperature-guided ablation in order to increase the safety profile of cryoballoon pulmonary vein isolation (PVI) by providing one center's experience. By trending cryoballoon ablation temperatures and subsequent esophageal temperatures, data trends may emerge and be predictive for esophageal ulceration formation. These trends may include:
Distance between esophagus and pulmonary vein in patients who developed post-ablation esophageal ulcerations
Intra-procedure esophageal temperatures in patients who developed post-ablation esophageal ulcerations
Intra-procedure cryoballoon temperatures in patients who developed post-ablation esophageal ulcerations
measure: Assessment of additional Adverse Events
time frame: 90 days or when complications resolve
description: To associate the development of symptoms (including dysphagia, chest pain, fever, "heartburn," or odynophagia) with the presence of ulcerations.
measure: Data collection on Phrenic Injury
time frame: 90 days or when complications resolve
description: Assess participants with abnormal imaging and/or adverse events that are related to the treatment.
arm group label: Multi-center, prospective outcomes registry
arm group type: Other
description: The study is a multi-center, prospective outcomes registry
intervention type: Procedure
intervention name: Esophageal Temperature-Guided Ablation
description: Esophageal temperature-guided ablation (if esophageal temperatures drop too low during cryoablation, the physician will stop the ablation) in order to increase the safety profile of cryoballoon pulmonary vein (a vein carrying blood from the participants lungs to the left side of the participants heart known as the left atrium) isolation (PVI [means a balloon shaped catheter will be placed at the opening of each pulmonary vein and tissue will be cooled in order to create an ablation line (line of scar tissue) between the left side of the participants heart and each pulmonary vein. This is done to prevent the triggers that typically cause intermittent atrial fibrillation (known as Paroxsymal Atrial Fibrillation) by providing one center's experience.
arm group label: Multi-center, prospective outcomes registry
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brian Deville, MD
role: Principal Investigator
affiliation: The Heart Hospital Baylor of Plano
responsible party type: Sponsor
mesh term: Atrial Fibrillation