<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/NCT04505163</url>
  </required_header>
  <id_info>
    <org_study_id>PIVoTAL-IDE</org_study_id>
    <nct_id>NCT04505163</nct_id>
  </id_info>
  <brief_title>Left Atrial Posterior Wall and PV Isolation Using Cryoballoon for Treatment of Persistent AF</brief_title>
  <acronym>PIVoTAL-IDE</acronym>
  <official_title>Left Atrial Posterior Wall Isolation in Conjunction With Pulmonary Vein Isolation Using the Cryoballoon for Treatment of Persistent Atrial Fibrillation (PIVoTAL) - IDE Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dignity Health Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mercy General Hospital and Dignity Health Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>UC Health Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>MedStar Georgetown University Hospital and Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tampa Cardiac Specialists</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bethesda North Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Texas Cardiac Arrhythmia Institute At St. Davids Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Luke's Hospital and Health Network, Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sarasota Memorial Health Care System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nebraska Methodist Hospital-Methodist Physicians Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dignity Health Medical Foundation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with&#xD;
      isolation of the posterior left atrial wall (PWI) in the region of the pulmonary venous&#xD;
      component will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with&#xD;
      persistent atrial fibrillation at 12 months, after a single ablation procedure, in comparison&#xD;
      to PVI alone.&#xD;
&#xD;
      The investigator hypothesizes that the combination of PVI + PWI will result in a significant&#xD;
      reduction in recurrence of atrial fibrillation at 12 months after ablation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with persistent atrial fibrillation will be enrolled in this multi-center,&#xD;
      randomized, prospective, single-blinded study. After catheter ablation (isolation) of the&#xD;
      pulmonary veins (PVI) and while still in the cardiac electrophysiology laboratory, all&#xD;
      patients will be randomized to either PVI alone or the combination of PVI + posterior left&#xD;
      atrial wall isolation (PWI). For patients randomized to PVI, their ablation procedure will be&#xD;
      completed at that time. For those patients randomized to PVI + PWI, they will have additional&#xD;
      ablation to achieve PWI.&#xD;
&#xD;
      All study patients will have the same follow-up after their ablation procedure, including&#xD;
      clinic visits at 3, 6, and 12 months and a heart event monitor for 7-14 days before these&#xD;
      visits. An echocardiogram (heart ultrasound) is performed at 6 to 12 months after the&#xD;
      ablation. Blood thinners are recommended for two months after ablation and then the need for&#xD;
      continued use of blood thinners will be based on individual patient's medical history, stroke&#xD;
      risk and the decision of the study doctor. Information about the patients' medical history,&#xD;
      heart arrhythmias and atrial fibrillation will be collected during the study which will be&#xD;
      analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 30, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2024</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>12-month freedom from recurrent atrial fibrillation</measure>
    <time_frame>12 months</time_frame>
    <description>Number of participants with recurrent atrial fibrillation following catheter ablation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All atrial arrhythmia recurrences</measure>
    <time_frame>During a follow-up period of 12 months</time_frame>
    <description>Number of atrial arrhythmia recurrences after the 90-day blanking period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale (CCS-SAF)</measure>
    <time_frame>During a follow-up period of 12 months</time_frame>
    <description>Change in CCS-SAF from baseline to 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT)</measure>
    <time_frame>During a follow-up period of 12 months</time_frame>
    <description>Change in AFEQT from baseline to 12 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple procedure success</measure>
    <time_frame>During a follow-up period of 12 months</time_frame>
    <description>Absence of recurrent atrial arrhythmias after one or more ablation procedure(s)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative reduction in atrial fibrillation burden</measure>
    <time_frame>During a follow-up period of 12 months</time_frame>
    <description>Reduction in the burden of atrial fibrillation (in percentage) following catheter ablation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from cardioversion for recurrent atrial arrhythmias</measure>
    <time_frame>During a follow-up period of 12 months</time_frame>
    <description>Electrical or pharmacological cardioversion for treatment of recurrent atrial arrhythmias not required</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from repeat atrial fibrillation ablation</measure>
    <time_frame>During a follow-up period of 12 months</time_frame>
    <description>Repeat ablation for atrial fibrillation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Atrial Diameter (Size) as predictor of atrial fibrillation recurrence</measure>
    <time_frame>During a follow-up period of 12 months</time_frame>
    <description>Change in left atrial diameter (in millimeters) following ablation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular Ejection Fraction as predictor of atrial fibrillation recurrence</measure>
    <time_frame>During a follow-up period of 12 months</time_frame>
    <description>Change in left atrial ejection fraction (in percentage) following ablation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New York Heart Association Functional Class as predictor of atrial fibrillation recurrence</measure>
    <time_frame>During a follow-up period of 12 months</time_frame>
    <description>Change in New York Heart Association Functional Class following ablation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">153</enrollment>
  <condition>Persistent Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Standard Cryoballoon Pulmonary Vein Isolation (PVI)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard cryoballoon pulmonary vein isolation alone using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cryoballoon PVI + Posterior Wall Isolation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cryoballoon pulmonary vein isolation in conjunction with posterior wall isolation using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard Cryoballoon Pulmonary Vein Isolation (PVI)</intervention_name>
    <description>Arctic Front Advance cryoballoon ablation system to ablate the pulmonary veins to achieve PVI alone</description>
    <arm_group_label>Standard Cryoballoon Pulmonary Vein Isolation (PVI)</arm_group_label>
    <other_name>Arctic Front Advance Cardiac Cryoablation System</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cryoballoon PVI + Posterior Wall Isolation</intervention_name>
    <description>Arctic Front Advance Cardiac Cryoballoon Ablation System to ablate the pulmonary veins and the left atrial posterior wall to achieve PVI + posterior wall isolation within the region of the pulmonary venous component</description>
    <arm_group_label>Cryoballoon PVI + Posterior Wall Isolation</arm_group_label>
    <other_name>Arctic Front Advance Cardiac Cryoablation System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consistent with the current definitions, all patients with Persistent AF must exhibit&#xD;
             an episode of continuous AF that is sustained &gt;7 days.&#xD;
&#xD;
          -  Patients must have symptomatic Persistent AF refractory or intolerant to at least one&#xD;
             class I or class III antiarrhythmic drug&#xD;
&#xD;
          -  Males and females with an age &gt;18 years undergoing a first-time catheter ablation of&#xD;
             AF; prior ablation of a right atrial cardiac arrhythmia (i.e., typical right atrial&#xD;
             flutter) is permitted&#xD;
&#xD;
          -  All patients must understand the requirements of the study and be willing to comply&#xD;
             with the post-study follow-up requirements&#xD;
&#xD;
          -  Patients must have documented episode of AF greater than 7 days in the year prior to&#xD;
             the procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of long-standing persistent AF&#xD;
&#xD;
          -  Any reversible cause of AF (post-operative, thyroid disorder, etc.)&#xD;
&#xD;
          -  Patients with cerebral ischemic events (stroke or transient ischemic attack),&#xD;
             myocardial infarction or unstable angina in the previous 2 months&#xD;
&#xD;
          -  Patients with any corrected or uncorrected congenital heart disease&#xD;
&#xD;
          -  Patients with a history of hypertrophic cardiomyopathy&#xD;
&#xD;
          -  Patients with cardiomyopathy and a left ventricular ejection fraction &lt;40%&#xD;
&#xD;
          -  Congestive heart failure, class IV&#xD;
&#xD;
          -  Left atrial (LA) diameter &gt;55 mm (parasternal long axis view)&#xD;
&#xD;
          -  Patients with left atrial thrombus&#xD;
&#xD;
          -  Women who are known to be pregnant or have had a positive β-HCG (human chorionic&#xD;
             gonadotropin) test 7 days prior to procedure&#xD;
&#xD;
          -  Patients whose life expectancy is &lt;1 year&#xD;
&#xD;
          -  History of left-sided left atrial ablation (catheter or surgically-based)&#xD;
&#xD;
          -  Mental impairment precluding the patient from providing informed consent or completing&#xD;
             appropriate follow-up&#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>Arash Aryana, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mercy General Hospital and Dignity Health Medical Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mercy General Hospital and Dignity Health Medical Foundation</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCHealth Medical Center</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80528</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedStar Georgetown University Hospital and Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarasota Memorial Health Care System</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa Cardiac Specialists</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33558</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>
    <facility>
      <name>Nebraska Methodist Hospital-Methodist Physicians Clinic</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bethesda North Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's University Health Network</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Cardiac Arrhythmia Institute &amp; St. David's Medical Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Japan</country>
  </removed_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>September 1, 2023</last_update_submitted>
  <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dignity Health Medical Foundation</investigator_affiliation>
    <investigator_full_name>Arash Aryana, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Atrial fibrillation</keyword>
  <keyword>Catheter ablation</keyword>
  <keyword>Cryoablation</keyword>
  <keyword>Cryoballoon</keyword>
  <keyword>Posterior left atrial wall ablation</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04505163
org study id: PIVoTAL-IDE
nct id: NCT04505163
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study it to learn whether pulmonary vein isolation (PVI) along with
      isolation of the posterior left atrial wall (PWI) in the region of the pulmonary venous
      component will reduce the likelihood of atrial fibrillation (AF) recurrence in patients with
      persistent atrial fibrillation at 12 months, after a single ablation procedure, in comparison
      to PVI alone.

      The investigator hypothesizes that the combination of PVI + PWI will result in a significant
      reduction in recurrence of atrial fibrillation at 12 months after ablation.
Patients with persistent atrial fibrillation will be enrolled in this multi-center,
      randomized, prospective, single-blinded study. After catheter ablation (isolation) of the
      pulmonary veins (PVI) and while still in the cardiac electrophysiology laboratory, all
      patients will be randomized to either PVI alone or the combination of PVI + posterior left
      atrial wall isolation (PWI). For patients randomized to PVI, their ablation procedure will be
      completed at that time. For those patients randomized to PVI + PWI, they will have additional
      ablation to achieve PWI.

      All study patients will have the same follow-up after their ablation procedure, including
      clinic visits at 3, 6, and 12 months and a heart event monitor for 7-14 days before these
      visits. An echocardiogram (heart ultrasound) is performed at 6 to 12 months after the
      ablation. Blood thinners are recommended for two months after ablation and then the need for
      continued use of blood thinners will be based on individual patient's medical history, stroke
      risk and the decision of the study doctor. Information about the patients' medical history,
      heart arrhythmias and atrial fibrillation will be collected during the study which will be
      analyzed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: 12-month freedom from recurrent atrial fibrillation
time frame: 12 months
description: Number of participants with recurrent atrial fibrillation following catheter ablation
measure: All atrial arrhythmia recurrences
time frame: During a follow-up period of 12 months
description: Number of atrial arrhythmia recurrences after the 90-day blanking period
measure: Change in Canadian Cardiovascular Society Severity of Atrial Fibrillation Scale (CCS-SAF)
time frame: During a follow-up period of 12 months
description: Change in CCS-SAF from baseline to 12 months
measure: Change in Atrial Fibrillation Effect on Quality of Life Questionnaire (AFEQT)
time frame: During a follow-up period of 12 months
description: Change in AFEQT from baseline to 12 months
measure: Multiple procedure success
time frame: During a follow-up period of 12 months
description: Absence of recurrent atrial arrhythmias after one or more ablation procedure(s)
measure: Relative reduction in atrial fibrillation burden
time frame: During a follow-up period of 12 months
description: Reduction in the burden of atrial fibrillation (in percentage) following catheter ablation
measure: Freedom from cardioversion for recurrent atrial arrhythmias
time frame: During a follow-up period of 12 months
description: Electrical or pharmacological cardioversion for treatment of recurrent atrial arrhythmias not required
measure: Freedom from repeat atrial fibrillation ablation
time frame: During a follow-up period of 12 months
description: Repeat ablation for atrial fibrillation
measure: Left Atrial Diameter (Size) as predictor of atrial fibrillation recurrence
time frame: During a follow-up period of 12 months
description: Change in left atrial diameter (in millimeters) following ablation
measure: Left Ventricular Ejection Fraction as predictor of atrial fibrillation recurrence
time frame: During a follow-up period of 12 months
description: Change in left atrial ejection fraction (in percentage) following ablation
measure: New York Heart Association Functional Class as predictor of atrial fibrillation recurrence
time frame: During a follow-up period of 12 months
description: Change in New York Heart Association Functional Class following ablation
arm group label: Standard Cryoballoon Pulmonary Vein Isolation (PVI)
arm group type: Active Comparator
description: Standard cryoballoon pulmonary vein isolation alone using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters
arm group label: Cryoballoon PVI + Posterior Wall Isolation
arm group type: Experimental
description: Cryoballoon pulmonary vein isolation in conjunction with posterior wall isolation using the Arctic Front Advance Cryoablation System family of cardiac ablation catheters
intervention type: Procedure
intervention name: Standard Cryoballoon Pulmonary Vein Isolation (PVI)
description: Arctic Front Advance cryoballoon ablation system to ablate the pulmonary veins to achieve PVI alone
arm group label: Standard Cryoballoon Pulmonary Vein Isolation (PVI)
other name: Arctic Front Advance Cardiac Cryoablation System
intervention type: Device
intervention name: Cryoballoon PVI + Posterior Wall Isolation
description: Arctic Front Advance Cardiac Cryoballoon Ablation System to ablate the pulmonary veins and the left atrial posterior wall to achieve PVI + posterior wall isolation within the region of the pulmonary venous component
arm group label: Cryoballoon PVI + Posterior Wall Isolation
other name: Arctic Front Advance Cardiac Cryoablation System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Arash Aryana, MD
role: Principal Investigator
affiliation: Mercy General Hospital and Dignity Health Medical Foundation
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Dignity Health Medical Foundation
investigator full name: Arash Aryana, MD
investigator title: Principal Investigator
mesh term: Atrial Fibrillation
sharing ipd: No