<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/NCT03786822</url>
  </required_header>
  <id_info>
    <org_study_id>STU 042013-074</org_study_id>
    <nct_id>NCT03786822</nct_id>
  </id_info>
  <brief_title>Reduction of Radiation Dose and Contrast Use During Cryoballoon Pulmonary Vein Isolation</brief_title>
  <official_title>Reduction of Radiation Dose and Contrast Use During Cryoballoon Pulmonary Vein Isolation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-site, randomized, investigator-initiated pilot study to evaluate the efficacy&#xD;
      of investigational techniques to reduce fluoroscopy time or radiation dose and the amount of&#xD;
      radio opaque contrast used during a cryoballoon pulmonary vein isolation procedure for atrial&#xD;
      fibrillation.&#xD;
&#xD;
      One group of subjects will have the procedure performed with intracardiac echo maneuvers to&#xD;
      assess cryoballoon occlusion of the pulmonary vein and will be compared to a group of&#xD;
      subjects who will receive the standard medical treatment with fluoroscopy and angiography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgical and catheter based technologies target triggers that initiate atrial fibrillation&#xD;
      located in the pulmonary veins (PV). In order to isolate these triggers, radiofrequency&#xD;
      energy or freezing is used to destroy the atrial tissue which propagate electrical impulses&#xD;
      into and out of the pulmonary veins (PV), to achieve pulmonary vein isolation (PVI). Use of a&#xD;
      patented cryoballoon catheter (Medtronic) to perform PVI has been shown to be safe and&#xD;
      efficacious under fluoroscopic guidance with contrast angiography. The objective of this&#xD;
      study is to identify methods to reduce radiation dose and radio opaque contrast use while&#xD;
      maintaining PVI efficacy and safety.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2015</start_date>
  <completion_date type="Actual">December 20, 2016</completion_date>
  <primary_completion_date type="Actual">December 20, 2016</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Condition or Disease: Paroxysmal atrial fibrillation&#xD;
Procedure: Cryoballoon Pulmonary Vein Isolation</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Subjects will be randomized in a 2:1 fashion</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of Radiation Dose during Cryoballoon Pulmonary Vein Isolation.</measure>
    <time_frame>one year</time_frame>
    <description>change in the composite endpoint of total fluoroscopy time (min)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reduction of Contrast during Cryoballoon Pulmonary Vein Isolation.</measure>
    <time_frame>one year</time_frame>
    <description>change in the composite endpoint of contrast (cc)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence of atrial fibrillation</measure>
    <time_frame>one year</time_frame>
    <description>•recurrence of atrial fibrillation after 1 month blanking period measured by ECG event monitoring at 6 and 12 month follow up (time to first recurrence in months, total number of episodes, and total duration in hours)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Cryoballoon Pulmonary Vein Isolation</measure>
    <time_frame>one year</time_frame>
    <description>•cryoballoon procedure time (min)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Non-fluoroscopic Cryoballoon PVI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Observation of pressure waveform change at the tip of the cryoballoon catheter from left atrial pressure to pulmonary vein pressure waveform.&#xD;
Intracardiac echocardiography (ICE) imaging with no Doppler color evidence of peri-balloon high velocity leaks.&#xD;
Intracardiac echo imaging showing no evidence of leak during agitated saline contrast injection into cryoballoon catheter positioned at pulmonary vein ostium.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluoroscopic Cryoballoon PVI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard cryoballoon PVI using radio opaque contrast pulmonary vein angiography</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cryoballoon Pulmonary Vein Isolation - PVI</intervention_name>
    <description>A 28-mm cryoballoon (Arctic Front Advance™ Cardiac CryoAblation Catheter, Medtronic, Minneapolis, MN) will be employed. The cryoballoon catheter will be introduced into the left atrium, following a single transeptal puncture, through a 12 French steerable sheath (FlexCath, Medtronic), constantly flushed with heparinized saline. A circular mapping catheter (Achieve, Medtronic) will be advanced through the cryoballoon to the PV orifice and positioned as proximally as possible inside the vessel to record the PV potentials at baseline and monitor the isolation procedure in real time.</description>
    <arm_group_label>Fluoroscopic Cryoballoon PVI</arm_group_label>
    <arm_group_label>Non-fluoroscopic Cryoballoon PVI</arm_group_label>
    <other_name>Atrial Fibrillation Ablation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Paroxysmal atrial fibrillation refractory to treatment with anti-arrhythmic drugs&#xD;
&#xD;
          -  Must be able to undergo pre-operative cardiac CT angiogram or cardiac MRI to define&#xD;
             pulmonary vein anatomy.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Planned use of radiofrequency cardiac ablation&#xD;
&#xD;
          -  Presence of a cardiac implantable electronic device&#xD;
&#xD;
          -  Conditions where manipulation of the catheter would be unsafe such as intracardiac&#xD;
             thrombus&#xD;
&#xD;
          -  Patients with active systemic infections&#xD;
&#xD;
          -  Patients with cryoglobulinemia&#xD;
&#xD;
          -  Pregnant and/or breast-feeding females are excluded from this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Texas Southwestern</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Richard Wu</investigator_full_name>
    <investigator_title>Professor of Internal Medicine</investigator_title>
  </responsible_party>
  <keyword>cryoballoon</keyword>
  <keyword>Atrial fibrillation</keyword>
  <keyword>pulmonary vein isolation</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/NCT03786822
org study id: STU 042013-074
nct id: NCT03786822
lead sponsor: 
collaborator: 
has dmc: No
This is a multi-site, randomized, investigator-initiated pilot study to evaluate the efficacy
      of investigational techniques to reduce fluoroscopy time or radiation dose and the amount of
      radio opaque contrast used during a cryoballoon pulmonary vein isolation procedure for atrial
      fibrillation.

      One group of subjects will have the procedure performed with intracardiac echo maneuvers to
      assess cryoballoon occlusion of the pulmonary vein and will be compared to a group of
      subjects who will receive the standard medical treatment with fluoroscopy and angiography.
Surgical and catheter based technologies target triggers that initiate atrial fibrillation
      located in the pulmonary veins (PV). In order to isolate these triggers, radiofrequency
      energy or freezing is used to destroy the atrial tissue which propagate electrical impulses
      into and out of the pulmonary veins (PV), to achieve pulmonary vein isolation (PVI). Use of a
      patented cryoballoon catheter (Medtronic) to perform PVI has been shown to be safe and
      efficacious under fluoroscopic guidance with contrast angiography. The objective of this
      study is to identify methods to reduce radiation dose and radio opaque contrast use while
      maintaining PVI efficacy and safety.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Condition or Disease: Paroxysmal atrial fibrillation
Procedure: Cryoballoon Pulmonary Vein Isolation
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Subjects will be randomized in a 2:1 fashion
measure: Reduction of Radiation Dose during Cryoballoon Pulmonary Vein Isolation.
time frame: one year
description: change in the composite endpoint of total fluoroscopy time (min)
measure: Reduction of Contrast during Cryoballoon Pulmonary Vein Isolation.
time frame: one year
description: change in the composite endpoint of contrast (cc)
measure: Recurrence of atrial fibrillation
time frame: one year
description: •recurrence of atrial fibrillation after 1 month blanking period measured by ECG event monitoring at 6 and 12 month follow up (time to first recurrence in months, total number of episodes, and total duration in hours)
measure: Time to Cryoballoon Pulmonary Vein Isolation
time frame: one year
description: •cryoballoon procedure time (min)
arm group label: Non-fluoroscopic Cryoballoon PVI
arm group type: Experimental
description: Observation of pressure waveform change at the tip of the cryoballoon catheter from left atrial pressure to pulmonary vein pressure waveform.
Intracardiac echocardiography (ICE) imaging with no Doppler color evidence of peri-balloon high velocity leaks.
Intracardiac echo imaging showing no evidence of leak during agitated saline contrast injection into cryoballoon catheter positioned at pulmonary vein ostium.
arm group label: Fluoroscopic Cryoballoon PVI
arm group type: Active Comparator
description: Standard cryoballoon PVI using radio opaque contrast pulmonary vein angiography
intervention type: Procedure
intervention name: Cryoballoon Pulmonary Vein Isolation - PVI
description: A 28-mm cryoballoon (Arctic Front Advance™ Cardiac CryoAblation Catheter, Medtronic, Minneapolis, MN) will be employed. The cryoballoon catheter will be introduced into the left atrium, following a single transeptal puncture, through a 12 French steerable sheath (FlexCath, Medtronic), constantly flushed with heparinized saline. A circular mapping catheter (Achieve, Medtronic) will be advanced through the cryoballoon to the PV orifice and positioned as proximally as possible inside the vessel to record the PV potentials at baseline and monitor the isolation procedure in real time.
arm group label: Fluoroscopic Cryoballoon PVI
arm group label: Non-fluoroscopic Cryoballoon PVI
other name: Atrial Fibrillation Ablation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Richard Wu
investigator title: Professor of Internal Medicine
mesh term: Atrial Fibrillation