<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/NCT03295422</url>
  </required_header>
  <id_info>
    <org_study_id>Persistent AF Study 01</org_study_id>
    <nct_id>NCT03295422</nct_id>
  </id_info>
  <brief_title>Comparison of Two Pulmonary Vein Ablation Techniques for Persistent AF</brief_title>
  <official_title>Investigator Initiated Randomized Controlled Trial Comparing Two Radiofrequency Ablation Strategies in Patients With Persistent Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sequoia Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sequoia Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigator initiated, randomized controlled trial of two radiofrequency (RF)ablation&#xD;
      protocols currently performed in the electrophysiology lab, but have not been studied&#xD;
      prospectively to identify which, if either technique, is superior for individuals with&#xD;
      persistent atrial fibrillation (AF). Two-hundred subjects will be consecutively enrolled and&#xD;
      randomized to either pulmonary vein isolation only or pulmonary vein isolation plus posterior&#xD;
      left atrial wall isolation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Atrial fibrillation, the most common type of cardiac arrhythmia in clinical practice, affects&#xD;
      approximately 2.7 million U.S. adults. Percutaneous catheter ablation is an effective&#xD;
      treatment option for individuals with persistent AF. Pulmonary vein isolation (PVI) has&#xD;
      emerged as the gold standard for paroxysmal AF with excellent success rates, however,&#xD;
      individuals with persistent AF procedural efficacy from pulmonary vein isolation is not&#xD;
      optimal. Therefore, improved ablation strategies for these individuals are needed.&#xD;
&#xD;
      This randomized controlled trial will compare two radiofrequency ablation strategies, PVI&#xD;
      alone and pulmonary vein isolation plus left posterior atrial wall (LPAW) isolation in&#xD;
      individuals with persistent AF. Both strategies are currently used to treat persistent AF,&#xD;
      but no randomized controlled trial ahs been conducted to investigate which strategy is more&#xD;
      efficacious.&#xD;
&#xD;
      Two-hundred subjects will be randomized into groups of 50 to undergo a radiofrequency&#xD;
      ablation procedure for AF. For group 1, a series of radiofrequency applications will be&#xD;
      delivered around both sets of pulmonary veins. For group 2, a series of radiofrequency&#xD;
      applications will be delivered around both sets of pulmonary veins and along a roof and low&#xD;
      posterior line of the left atrial wall.&#xD;
&#xD;
      All subjects will be followed at 1 month, 3 months, 6 months, and 1 year post ablation. If&#xD;
      indicated, antiarrhythmic drugs will be discontinued. For the first month, subjects will&#xD;
      receive a continuously recording electrocardiogram heart card to monitor for AF, and then&#xD;
      two-week ambulatory monitors at 3 months and one year post ablation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 25, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>1-year freedom from recurrent atrial arrhythmias</measure>
    <time_frame>1 Year</time_frame>
    <description>The primary hypotheses that PVI+PI will lead to a greater percentage of patients free from atrial arrhythmias after single ablation procedures than PVI alone.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Chronic Atrial Fibrillation</condition>
  <condition>Persistent Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>RF ablation PVI alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>RF catheter ablation of pulmonary veins alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RF ablation PVI plus LPAW</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RF catheter ablation PVI plus left atrial posterior wall</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>RF ablation PVI alone</intervention_name>
    <description>A series of RF applications will be delivered around both sets of pulmonary veins with complete entry and exit block obtained around the antrums of all 4 pulmonary veins.</description>
    <arm_group_label>RF ablation PVI alone</arm_group_label>
    <other_name>Catheter ablation of the pulmonary veins</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>RF ablation PVI plus LPAW</intervention_name>
    <description>A series of RF applications will be delivered around both sets of pulmonary veins with complete entry and exit block obtained around the antrums of all 4 pulmonary veins. In addition, a roof and posterior line will be placed in the left atrium to achieve entrance and exit block on the posterior wall. Entry block will be confirmed by placing a circular mapping catheter in multiple locations along the posterior wall and confirming lack of presence of any local potentials. Exit block will be confirmed on the posterior wall with pacing at 10 amps from the ablation catheter at multiple locations within the box as well as all lines.</description>
    <arm_group_label>RF ablation PVI plus LPAW</arm_group_label>
    <other_name>Catheter ablation of the pulmonary veins plus posterior wall</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Have symptomatic persistent AF (i.e., a sustained episode lasting more than 7 days).&#xD;
&#xD;
          2. Refractory to at least one antiarrhythmic agent.&#xD;
&#xD;
          3. Undergoing ablation for the first time.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Paroxysmal AF&#xD;
&#xD;
          2. Sustained atrial fibrillation lasting more than 3 years&#xD;
&#xD;
          3. Left atrial diameter of 60 mm or greater&#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>Christopher E Woods, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dignity Health, Sequoia Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christopher E Woods, MD, PhD</last_name>
    <phone>650-652-8600</phone>
    <email>WoodC@sutterhealth.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ann Campbell, RN, MBA</last_name>
    <phone>650-367-5950</phone>
    <email>ann.campbell@dignityhealth.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dignity Health, Sequoia Hospital</name>
      <address>
        <city>Redwood City</city>
        <state>California</state>
        <zip>94062</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christopher E Woods, MD, PhD</last_name>
      <phone>650-652-8600</phone>
      <email>woodsC@sutterhealth.org</email>
    </contact>
    <contact_backup>
      <last_name>Ann Campbell, RN, MBA</last_name>
      <phone>650-367-5950</phone>
      <email>ann.campbell@dignityhealth.org</email>
    </contact_backup>
    <investigator>
      <last_name>Christopher E Woods, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>November 18, 2020</last_update_submitted>
  <last_update_submitted_qc>November 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sequoia Hospital</investigator_affiliation>
    <investigator_full_name>Christopher E. Woods, MD, PhD</investigator_full_name>
    <investigator_title>Study Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Persistent Atrial Fibrillation</keyword>
  <keyword>Radiofrequency ablation</keyword>
  <keyword>Catheter ablation</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT03295422/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03295422
org study id: Persistent AF Study 01
nct id: NCT03295422
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigator initiated, randomized controlled trial of two radiofrequency (RF)ablation
      protocols currently performed in the electrophysiology lab, but have not been studied
      prospectively to identify which, if either technique, is superior for individuals with
      persistent atrial fibrillation (AF). Two-hundred subjects will be consecutively enrolled and
      randomized to either pulmonary vein isolation only or pulmonary vein isolation plus posterior
      left atrial wall isolation
Atrial fibrillation, the most common type of cardiac arrhythmia in clinical practice, affects
      approximately 2.7 million U.S. adults. Percutaneous catheter ablation is an effective
      treatment option for individuals with persistent AF. Pulmonary vein isolation (PVI) has
      emerged as the gold standard for paroxysmal AF with excellent success rates, however,
      individuals with persistent AF procedural efficacy from pulmonary vein isolation is not
      optimal. Therefore, improved ablation strategies for these individuals are needed.

      This randomized controlled trial will compare two radiofrequency ablation strategies, PVI
      alone and pulmonary vein isolation plus left posterior atrial wall (LPAW) isolation in
      individuals with persistent AF. Both strategies are currently used to treat persistent AF,
      but no randomized controlled trial ahs been conducted to investigate which strategy is more
      efficacious.

      Two-hundred subjects will be randomized into groups of 50 to undergo a radiofrequency
      ablation procedure for AF. For group 1, a series of radiofrequency applications will be
      delivered around both sets of pulmonary veins. For group 2, a series of radiofrequency
      applications will be delivered around both sets of pulmonary veins and along a roof and low
      posterior line of the left atrial wall.

      All subjects will be followed at 1 month, 3 months, 6 months, and 1 year post ablation. If
      indicated, antiarrhythmic drugs will be discontinued. For the first month, subjects will
      receive a continuously recording electrocardiogram heart card to monitor for AF, and then
      two-week ambulatory monitors at 3 months and one year post ablation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: 1-year freedom from recurrent atrial arrhythmias
time frame: 1 Year
description: The primary hypotheses that PVI+PI will lead to a greater percentage of patients free from atrial arrhythmias after single ablation procedures than PVI alone.
arm group label: RF ablation PVI alone
arm group type: Active Comparator
description: RF catheter ablation of pulmonary veins alone
arm group label: RF ablation PVI plus LPAW
arm group type: Experimental
description: RF catheter ablation PVI plus left atrial posterior wall
intervention type: Procedure
intervention name: RF ablation PVI alone
description: A series of RF applications will be delivered around both sets of pulmonary veins with complete entry and exit block obtained around the antrums of all 4 pulmonary veins.
arm group label: RF ablation PVI alone
other name: Catheter ablation of the pulmonary veins
intervention type: Procedure
intervention name: RF ablation PVI plus LPAW
description: A series of RF applications will be delivered around both sets of pulmonary veins with complete entry and exit block obtained around the antrums of all 4 pulmonary veins. In addition, a roof and posterior line will be placed in the left atrium to achieve entrance and exit block on the posterior wall. Entry block will be confirmed by placing a circular mapping catheter in multiple locations along the posterior wall and confirming lack of presence of any local potentials. Exit block will be confirmed on the posterior wall with pacing at 10 amps from the ablation catheter at multiple locations within the box as well as all lines.
arm group label: RF ablation PVI plus LPAW
other name: Catheter ablation of the pulmonary veins plus posterior wall
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christopher E Woods, MD, PhD
role: Principal Investigator
affiliation: Dignity Health, Sequoia Hospital
last name: Christopher E Woods, MD, PhD
phone: 650-652-8600
email: WoodC@sutterhealth.org
last name: Ann Campbell, RN, MBA
phone: 650-367-5950
email: ann.campbell@dignityhealth.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Sequoia Hospital
investigator full name: Christopher E. Woods, MD, PhD
investigator title: Study Principal Investigator
mesh term: Atrial Fibrillation
sharing ipd: No
provided document: 