<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/NCT01672346</url>
  </required_header>
  <id_info>
    <org_study_id>ZODIAC_TCAI</org_study_id>
    <nct_id>NCT01672346</nct_id>
  </id_info>
  <brief_title>PV Reconnection After PVAI at Different Power Settings and Adenosine Provocation</brief_title>
  <acronym>ZODIAC</acronym>
  <official_title>Pulmonary Vein (PV) Reconnection After Pulmonary Vein Antrm Isolation (PVAI) at Different Power Settings and Adenosine Provocation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Cardiac Arrhythmia Research Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>California Pacific Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Texas Cardiac Arrhythmia Research Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this prospective randomized study, we aim to compare the rate of PV reconnection following&#xD;
      PVAI performed at different energy settings (30 Watts vs 40 Watts) where dormant PV&#xD;
      conduction will be unmasked by adenosine-provocation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      The efficiency of catheter ablation in drug-refractory atrial fibrillation (AF) is&#xD;
      compromised by high incidence of post-ablation AF recurrences requiring multiple ablation&#xD;
      procedures (1). Post-PVAI (pulmonary vein antrum isolation) AF recurrence is mostly due to&#xD;
      reconnection of the previously isolated PVs (2). Earlier studies have revealed that&#xD;
      elimination of dormant PV conduction revealed by adenosine-provocation ensures better outcome&#xD;
      as reconnection mostly happens due to presence of incompletely ablated tissue and&#xD;
      identification and complete ablation decrease chance of recurrence (1). Adenosine is&#xD;
      specifically chosen for induction of triggers because it is known to transiently or&#xD;
      permanently re-establish left atrium-pulmonary vein (LA-PV) conduction after apparently&#xD;
      successful PV isolation (3). Datino et al have demonstrated in the canines that adenosine&#xD;
      selectively hyperpolarizes the PVs by increasing inward rectifier potassium (K+) current and&#xD;
      restores excitability (4). As incompletely ablated tissue can potentially cause AF&#xD;
      recurrence, the depth and extension of the lesion are crucial factors in determining the&#xD;
      success-rate of ablation; these in turn are directly influenced by catheter type and the&#xD;
      radio-frequency (RF) energy settings (5). In a previous study, Matiello et al have reported&#xD;
      cooled-tip catheter at 40w setting to be more effective in preventing recurrence than that&#xD;
      with 30w setting (5). However, none of the earlier studies have examined the rate of PV&#xD;
      reconnection when AF ablation is done at different power settings using open-irrigated&#xD;
      catheters after the dormant sites are revealed by adenosine-challenge.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      Use of higher wattage during ablation before and after adenosine-challenge is associated with&#xD;
      lower rate of PV reconnection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2013</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AF recurrence</measure>
    <time_frame>1 year</time_frame>
    <description>Recurrence of AF due to PV reconnection AF recurrence is defined as any episode of AF/AT (atrial tachycardia) longer than 30 seconds will be considered as recurrence. Episodes that occur during the first 3 months of the procedure (blanking period) will not be considered as recurrence.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">188</enrollment>
  <condition>Paroxysmal Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Arm I</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PVAI with ablation of posterior wall contained within pulmonary veins using energy up to 30 watts and post-ablation adenosine challenge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>AF ablationPVAI with ablation of posterior wall contained within pulmonary veins using energy up to 40 watts and post-ablation adenosine challenge</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PVAI followed by adenosine provocation</intervention_name>
    <description>All patients will undergo PVAI and ablation of the posterior wall of the LA using an open-irrigated ablation catheter and under general anesthesia. After PV isolation is achieved, all will undergo PVAI followed by adenosine provocation test with 24 mg of adenosine to check for PV reconnection. Upon identification, additional RF energy would be used to ablate those sites (that were revealed by adenosine-provocation).</description>
    <arm_group_label>Arm I</arm_group_label>
    <arm_group_label>Arm II</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years&#xD;
&#xD;
          2. Patients presenting with drug-refractory PAF undergoing first ablation&#xD;
&#xD;
          3. Ability to understand and provide signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous catheter ablation or MAZE procedure in left atrium&#xD;
&#xD;
          2. Reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary&#xD;
             embolism etc&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea Natale, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>TCAI</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andrea Natale, MD</last_name>
    <email>dr.natale@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Luigi Di Biase, MD</last_name>
    <email>dibbia@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>St. david's Medical Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Luigi Di Biase, MD PhD</last_name>
      <email>dibbia@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Mitra Mohanty, MD</last_name>
      <email>mitra1989@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Texas Cardiac arrhythmia Institute, St. David's Hospital</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Natale, MD</last_name>
      <phone>512-544-8186</phone>
      <email>dr.natale@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>April 8, 2019</last_update_submitted>
  <last_update_submitted_qc>April 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Texas Cardiac Arrhythmia Research Foundation</investigator_affiliation>
    <investigator_full_name>Andrea Natale</investigator_full_name>
    <investigator_title>Executive medical director, TCAI</investigator_title>
  </responsible_party>
  <keyword>PAF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenosine</mesh_term>
  </intervention_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/NCT01672346
org study id: ZODIAC_TCAI
nct id: NCT01672346
lead sponsor: 
collaborator: 
has dmc: No
In this prospective randomized study, we aim to compare the rate of PV reconnection following
      PVAI performed at different energy settings (30 Watts vs 40 Watts) where dormant PV
      conduction will be unmasked by adenosine-provocation.
Background:

      The efficiency of catheter ablation in drug-refractory atrial fibrillation (AF) is
      compromised by high incidence of post-ablation AF recurrences requiring multiple ablation
      procedures (1). Post-PVAI (pulmonary vein antrum isolation) AF recurrence is mostly due to
      reconnection of the previously isolated PVs (2). Earlier studies have revealed that
      elimination of dormant PV conduction revealed by adenosine-provocation ensures better outcome
      as reconnection mostly happens due to presence of incompletely ablated tissue and
      identification and complete ablation decrease chance of recurrence (1). Adenosine is
      specifically chosen for induction of triggers because it is known to transiently or
      permanently re-establish left atrium-pulmonary vein (LA-PV) conduction after apparently
      successful PV isolation (3). Datino et al have demonstrated in the canines that adenosine
      selectively hyperpolarizes the PVs by increasing inward rectifier potassium (K+) current and
      restores excitability (4). As incompletely ablated tissue can potentially cause AF
      recurrence, the depth and extension of the lesion are crucial factors in determining the
      success-rate of ablation; these in turn are directly influenced by catheter type and the
      radio-frequency (RF) energy settings (5). In a previous study, Matiello et al have reported
      cooled-tip catheter at 40w setting to be more effective in preventing recurrence than that
      with 30w setting (5). However, none of the earlier studies have examined the rate of PV
      reconnection when AF ablation is done at different power settings using open-irrigated
      catheters after the dormant sites are revealed by adenosine-challenge.

      Hypothesis:

      Use of higher wattage during ablation before and after adenosine-challenge is associated with
      lower rate of PV reconnection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: AF recurrence
time frame: 1 year
description: Recurrence of AF due to PV reconnection AF recurrence is defined as any episode of AF/AT (atrial tachycardia) longer than 30 seconds will be considered as recurrence. Episodes that occur during the first 3 months of the procedure (blanking period) will not be considered as recurrence.
arm group label: Arm I
arm group type: Active Comparator
description: PVAI with ablation of posterior wall contained within pulmonary veins using energy up to 30 watts and post-ablation adenosine challenge
arm group label: Arm II
arm group type: Active Comparator
description: AF ablationPVAI with ablation of posterior wall contained within pulmonary veins using energy up to 40 watts and post-ablation adenosine challenge
intervention type: Procedure
intervention name: PVAI followed by adenosine provocation
description: All patients will undergo PVAI and ablation of the posterior wall of the LA using an open-irrigated ablation catheter and under general anesthesia. After PV isolation is achieved, all will undergo PVAI followed by adenosine provocation test with 24 mg of adenosine to check for PV reconnection. Upon identification, additional RF energy would be used to ablate those sites (that were revealed by adenosine-provocation).
arm group label: Arm I
arm group label: Arm II
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Andrea Natale, MD
role: Principal Investigator
affiliation: TCAI
last name: Andrea Natale, MD
email: dr.natale@gmail.com
last name: Luigi Di Biase, MD
email: dibbia@gmail.com
facility: 
status: Not yet recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Texas Cardiac Arrhythmia Research Foundation
investigator full name: Andrea Natale
investigator title: Executive medical director, TCAI
mesh term: Atrial Fibrillation
mesh term: Adenosine