<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/NCT02217254</url>
  </required_header>
  <id_info>
    <org_study_id>UC-OF01</org_study_id>
    <nct_id>NCT02217254</nct_id>
  </id_info>
  <brief_title>The OneFreeze Study</brief_title>
  <acronym>OneFreeze</acronym>
  <official_title>A Prospective Multi-center Randomized Controlled Trial to Assess the Safety and Efficacy of One vs. Two Cryoablations Per Pulmonary Vein for the Treatment of Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The One Freeze study is a prospective multi-center randomized controlled trial to assess the&#xD;
      safety and efficacy of one vs. two cryoablations per pulmonary vein for the treatment of&#xD;
      atrial fibrillation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The One Freeze Trial is an investigator-initiated trial that has been developed by the&#xD;
      Principals at the University of California, San Francisco (UCSF) and with full participation&#xD;
      of the Steering Committee. One Freezel is a prospective multicenter randomized controlled&#xD;
      trial with a goal to enroll and randomize a minimum of 90 study participants. Participants&#xD;
      will be randomized in a 1:1 ratio to either PVI with a single freeze per pulmonary vein (1F&#xD;
      Group) or to PVI with at least two freezes per pulmonary vein (2F Group). The One Freeze&#xD;
      study's primary aim is to determine if one 3-minute cryoablation per pulmonary vein results&#xD;
      in a lower composite adverse event score as compared to the traditional method of using two&#xD;
      3-minute cryoablations per pulmonary vein.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">October 2019</completion_date>
  <primary_completion_date type="Actual">October 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite Score of Adverse Events</measure>
    <time_frame>12 months</time_frame>
    <description>Composite score of adverse events (Range 0-20 points) will be calculated after the patient has completed follow-up. Higher scores indicate greater severity.&#xD;
Luminal Esophageal Temperature (LET) (0-2 points): 1-point if ≤20 degrees C, 2-points if ≤15 degrees C&#xD;
Phrenic nerve injury (0-3 points): 1-point if ≥30% decrease in compound muscle action potential (CMAP) or loss of phrenic nerve capture resulting in cessation of freeze (without movement of pacing catheter), 2-points if Phrenic nerve palsy lasting&gt; 1 minute resolving on table, 3-points if Phrenic nerve palsy not resolving on the table&#xD;
Pulmonary (0-4 points): 1-point if persistent dry cough &gt; 1 week post ablation, 4-points if Hemoptysis&#xD;
Gastrointestinal (GI) (0-6 points): 1-point if Gastroparesis symptoms, 3-points if Esophageal ulceration, 6-points if left atrial-esophageal fistula&#xD;
Pulmonary vein (PV) stenosis (0-5 points): 1-point if ≥50% luminal area, 4-points if ≥90% luminal area, 5-points if total occlusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participants free from symptomatic atrial fibrillation (AF)</measure>
    <time_frame>6 months and 12 months</time_frame>
    <description>Participants experiencing no episodes of AF greater than 30 seconds, excluding episodes documented in the blanking period (6 weeks post-ablation for paroxysmal AF patients).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial Fibrillation (AF) burden</measure>
    <time_frame>6 months, 12 months</time_frame>
    <description>AF burden is defined as the overall percentage of AF during the 14-day observed period on Holter monitoring at 6 months and 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure Time</measure>
    <time_frame>4 - 8 hours</time_frame>
    <description>The duration of the Pulmonary Vein Isolation procedure from first leg puncture to removal of ablation catheter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Atrial Access time</measure>
    <time_frame>4 - 8 hours</time_frame>
    <description>Time it takes to gain transseptal access during the catheter ablation procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy Time</measure>
    <time_frame>4 - 8 hours</time_frame>
    <description>The amount of time in minutes (and milligray (mGy)/millisievert (mSv) dosage) of fluoroscopy used during the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cryoablations needed to isolate each vein</measure>
    <time_frame>4 - 8 hours</time_frame>
    <description>Number of cryoablations needed to isolate each vein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute success of the Pulmonary Vein Isolation (PVI)</measure>
    <time_frame>4 - 8 hours</time_frame>
    <description>percentage of pulmonary veins isolated during the catheter ablation procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Individual Adverse Events</measure>
    <time_frame>within 12 months after the Pulmonary Vein Isolation (PVI)</time_frame>
    <description>Number and severity of adverse events following the PVI procedure during the 12-month follow-up window</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of re-isolations required</measure>
    <time_frame>4 - 8 hours</time_frame>
    <description>Number of pulmonary veins requiring touch up for re-isolation after initial isolation was achieved.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Paroxysmal Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>two 3-minute cryoablations</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>two 3-minute cryoablations per pulmonary vein during an atrial fibrillation ablation procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>One 3-minute cryoablation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One 3-minute cryoablation per pulmonary vein during an atrial fibrillation ablation procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System</intervention_name>
    <arm_group_label>One 3-minute cryoablation</arm_group_label>
    <arm_group_label>two 3-minute cryoablations</arm_group_label>
    <other_name>Pulmonary vein isolation</other_name>
    <other_name>Cryoballoon catheter ablation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Paroxysmal atrial fibrillation&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Life expectancy ≥ 1 year&#xD;
&#xD;
          -  Willing and able to return to and comply with scheduled follow-up visits&#xD;
&#xD;
          -  Willing and able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of &gt; 5 electric cardioversions&#xD;
&#xD;
          -  History of previous pulmonary vein isolation ablation for atrial fibrillation&#xD;
&#xD;
          -  History of MAZE procedure&#xD;
&#xD;
          -  Left ventricular EF ≤ 35% within the past 12 months&#xD;
&#xD;
          -  Mechanical mitral valve&#xD;
&#xD;
          -  Single PV &gt; 30 mm in diameter, unless deemed appropriate by the site PI&#xD;
&#xD;
          -  Stroke/TIA within the past 6 months&#xD;
&#xD;
          -  Creatinine &gt; 2.0 mg/dL within the past 6 months&#xD;
&#xD;
          -  Pregnancy or desire to get pregnant within the next 12 months&#xD;
&#xD;
          -  Current enrollment in an investigation or study of a cardiovascular device or&#xD;
             investigational drug that would interfere with this study&#xD;
&#xD;
          -  Mental impairment or other conditions, which may not allow the participant to&#xD;
             understand the nature, significance and scope of the study&#xD;
&#xD;
          -  Any other condition or circumstance that in the judgment of the Clinical Site&#xD;
             Investigator that makes the participant unsuitable for the study&#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>Byron K Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal Heart Institute</name>
      <address>
        <city>Québec</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>December 4, 2020</last_update_submitted>
  <last_update_submitted_qc>December 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02217254
org study id: UC-OF01
nct id: NCT02217254
lead sponsor: 
collaborator: 
has dmc: Yes
The One Freeze study is a prospective multi-center randomized controlled trial to assess the
      safety and efficacy of one vs. two cryoablations per pulmonary vein for the treatment of
      atrial fibrillation.
The One Freeze Trial is an investigator-initiated trial that has been developed by the
      Principals at the University of California, San Francisco (UCSF) and with full participation
      of the Steering Committee. One Freezel is a prospective multicenter randomized controlled
      trial with a goal to enroll and randomize a minimum of 90 study participants. Participants
      will be randomized in a 1:1 ratio to either PVI with a single freeze per pulmonary vein (1F
      Group) or to PVI with at least two freezes per pulmonary vein (2F Group). The One Freeze
      study's primary aim is to determine if one 3-minute cryoablation per pulmonary vein results
      in a lower composite adverse event score as compared to the traditional method of using two
      3-minute cryoablations per pulmonary vein.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Composite Score of Adverse Events
time frame: 12 months
description: Composite score of adverse events (Range 0-20 points) will be calculated after the patient has completed follow-up. Higher scores indicate greater severity.
Luminal Esophageal Temperature (LET) (0-2 points): 1-point if ≤20 degrees C, 2-points if ≤15 degrees C
Phrenic nerve injury (0-3 points): 1-point if ≥30% decrease in compound muscle action potential (CMAP) or loss of phrenic nerve capture resulting in cessation of freeze (without movement of pacing catheter), 2-points if Phrenic nerve palsy lasting> 1 minute resolving on table, 3-points if Phrenic nerve palsy not resolving on the table
Pulmonary (0-4 points): 1-point if persistent dry cough > 1 week post ablation, 4-points if Hemoptysis
Gastrointestinal (GI) (0-6 points): 1-point if Gastroparesis symptoms, 3-points if Esophageal ulceration, 6-points if left atrial-esophageal fistula
Pulmonary vein (PV) stenosis (0-5 points): 1-point if ≥50% luminal area, 4-points if ≥90% luminal area, 5-points if total occlusion
measure: Participants free from symptomatic atrial fibrillation (AF)
time frame: 6 months and 12 months
description: Participants experiencing no episodes of AF greater than 30 seconds, excluding episodes documented in the blanking period (6 weeks post-ablation for paroxysmal AF patients).
measure: Atrial Fibrillation (AF) burden
time frame: 6 months, 12 months
description: AF burden is defined as the overall percentage of AF during the 14-day observed period on Holter monitoring at 6 months and 12 months.
measure: Procedure Time
time frame: 4 - 8 hours
description: The duration of the Pulmonary Vein Isolation procedure from first leg puncture to removal of ablation catheter
measure: Left Atrial Access time
time frame: 4 - 8 hours
description: Time it takes to gain transseptal access during the catheter ablation procedure
measure: Fluoroscopy Time
time frame: 4 - 8 hours
description: The amount of time in minutes (and milligray (mGy)/millisievert (mSv) dosage) of fluoroscopy used during the procedure
measure: Number of cryoablations needed to isolate each vein
time frame: 4 - 8 hours
description: Number of cryoablations needed to isolate each vein
measure: Acute success of the Pulmonary Vein Isolation (PVI)
time frame: 4 - 8 hours
description: percentage of pulmonary veins isolated during the catheter ablation procedure
measure: Individual Adverse Events
time frame: within 12 months after the Pulmonary Vein Isolation (PVI)
description: Number and severity of adverse events following the PVI procedure during the 12-month follow-up window
measure: Number of re-isolations required
time frame: 4 - 8 hours
description: Number of pulmonary veins requiring touch up for re-isolation after initial isolation was achieved.
arm group label: two 3-minute cryoablations
arm group type: Active Comparator
description: two 3-minute cryoablations per pulmonary vein during an atrial fibrillation ablation procedure
arm group label: One 3-minute cryoablation
arm group type: Active Comparator
description: One 3-minute cryoablation per pulmonary vein during an atrial fibrillation ablation procedure
intervention type: Procedure
intervention name: Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System
arm group label: One 3-minute cryoablation
arm group label: two 3-minute cryoablations
other name: Pulmonary vein isolation
other name: Cryoballoon catheter ablation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Byron K Lee, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation