<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/NCT01672138</url>
  </required_header>
  <id_info>
    <org_study_id>TANTRA_TCAI</org_study_id>
    <nct_id>NCT01672138</nct_id>
  </id_info>
  <brief_title>Pulmonary Vein Antrum Isolation (PVAI) Plus Scar Homogenization and Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation</brief_title>
  <acronym>TANTRA</acronym>
  <official_title>PVAI Plus Scar Homogenization and Ablation of Non-PV Triggers Ensure Long-term Recurrence-free Survival in Non-paroxysmal Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Cardiac Arrhythmia Research Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>RCCS Monzino Hospital, Milan, Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ospedale dell'Angelo, Venezia-Mestre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Texas Cardiac Arrhythmia Research Foundation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to examine the long-term success rate of catheter ablation in non-paroxysmal&#xD;
      atrial fibrillation patients using different ablation strategies such as : (i) pulmonary vein&#xD;
      antrum isolation (PVAI) + isolation of left atrial posterior wall, (ii) PVAI plus scar&#xD;
      homogenization, (iii) PVAI plus isolation of posterior wall plus ablation of non-PV triggers&#xD;
      [ PVAI: Pulmonary Vein Antrum Isolation&#xD;
&#xD;
      Non-PV triggers: Triggers arising from sites other than pulmonary veins]&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Back ground: Pulmonary vein antrum isolation (PVAI) as a lone procedure, is known to have&#xD;
      limited success rate in terms of long-term recurrence-free survival in non-paroxysmal atrial&#xD;
      fibrillation (NPAF) and additional ablations isolating extra-PV triggers seem to improve the&#xD;
      outcome (1). The extra-PV triggers include triggers from other sites such as left atrial&#xD;
      posterior wall, superior vena cava, interatrial septum, crista terminalis, left atrial&#xD;
      appendage and coronary sinus (1, 2). These are known to be independent predictors of late AF&#xD;
      recurrence following catheter ablation (3, 4, and 5). Earlier studies have demonstrated&#xD;
      better ablation outcome in NPAF when non-PV triggers sites were isolated along with PVAI (5,&#xD;
      6). Moreover, Verma et al had reported high (57%) recurrence rate post-index procedure in AF&#xD;
      patients with pre-existent scar (7). However, published data are conflicting regarding the&#xD;
      benefits of additional substrate guided ablation (scar homogenization) compared to&#xD;
      conventional PVAI alone strategy (8). Also, limited data is available showing a comparison of&#xD;
      the lasting efficacy of the above three procedures when used in different combinations.&#xD;
&#xD;
      Hypothesis: The combined ablation strategy including PVAI, scar homogenization and ablation&#xD;
      of extra-PV triggers has the highest likelihood of maintaining long-term sinus rhythm in&#xD;
      patients with NPAF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 2013</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence of atrial arrhythmia</measure>
    <time_frame>3 years</time_frame>
    <description>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>
  <secondary_outcome>
    <measure>Improvement in quality of life</measure>
    <time_frame>3 years</time_frame>
    <description>Improvement in quality of life</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">186</enrollment>
  <condition>Persistent Atrial Fibrillation</condition>
  <condition>Long-standing Persistent Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pulmonary Vein Antrum Isolation (PVAI) + isolation of left atrial posterior wall</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study I</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PVAI+ scar homogenization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study II</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PVAI + isolation of left atrial posterior wall + non-PV triggers ablation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pulmonary Vein Antrum Isolation</intervention_name>
    <description>Radio-frequency catheter ablation of pulmonary vein antrum extended to the left atrial posterior wall</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Study I</arm_group_label>
    <arm_group_label>Study II</arm_group_label>
    <other_name>PVAI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>scar homogenization</intervention_name>
    <description>PVAI + RF energy will be delivered until all abnormal potentials in the low-voltage areas are eliminated.</description>
    <arm_group_label>Study I</arm_group_label>
    <arm_group_label>Study II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non-PV triggers ablation</intervention_name>
    <description>PVAI + Isolation of LA posterior wall + Catheter ablation of triggers originating from extra-PV sites</description>
    <arm_group_label>Study II</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years&#xD;
&#xD;
          2. Patients undergoing first catheter ablation for drug-refractory Persistent (PerAF) or&#xD;
             long-standing persistent AF (LSPAF)&#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>Mitra Mohanty, MD</last_name>
    <email>mitra.mohanty@stdavids.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>Recruiting</status>
    <contact>
      <last_name>Mitra Mohanty, MD</last_name>
      <phone>512-544-8198</phone>
      <email>mitra1989@gmail.com</email>
    </contact>
    <contact_backup>
      <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>November 2018</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>November 14, 2018</last_update_submitted>
  <last_update_submitted_qc>November 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2018</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>PVAI</keyword>
  <keyword>NPAF</keyword>
  <keyword>Non-PV triggers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Recurrence</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/NCT01672138
org study id: TANTRA_TCAI
nct id: NCT01672138
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This study aims to examine the long-term success rate of catheter ablation in non-paroxysmal
      atrial fibrillation patients using different ablation strategies such as : (i) pulmonary vein
      antrum isolation (PVAI) + isolation of left atrial posterior wall, (ii) PVAI plus scar
      homogenization, (iii) PVAI plus isolation of posterior wall plus ablation of non-PV triggers
      [ PVAI: Pulmonary Vein Antrum Isolation

      Non-PV triggers: Triggers arising from sites other than pulmonary veins]
Back ground: Pulmonary vein antrum isolation (PVAI) as a lone procedure, is known to have
      limited success rate in terms of long-term recurrence-free survival in non-paroxysmal atrial
      fibrillation (NPAF) and additional ablations isolating extra-PV triggers seem to improve the
      outcome (1). The extra-PV triggers include triggers from other sites such as left atrial
      posterior wall, superior vena cava, interatrial septum, crista terminalis, left atrial
      appendage and coronary sinus (1, 2). These are known to be independent predictors of late AF
      recurrence following catheter ablation (3, 4, and 5). Earlier studies have demonstrated
      better ablation outcome in NPAF when non-PV triggers sites were isolated along with PVAI (5,
      6). Moreover, Verma et al had reported high (57%) recurrence rate post-index procedure in AF
      patients with pre-existent scar (7). However, published data are conflicting regarding the
      benefits of additional substrate guided ablation (scar homogenization) compared to
      conventional PVAI alone strategy (8). Also, limited data is available showing a comparison of
      the lasting efficacy of the above three procedures when used in different combinations.

      Hypothesis: The combined ablation strategy including PVAI, scar homogenization and ablation
      of extra-PV triggers has the highest likelihood of maintaining long-term sinus rhythm in
      patients with NPAF.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recurrence of atrial arrhythmia
time frame: 3 years
description: 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.
measure: Improvement in quality of life
time frame: 3 years
description: Improvement in quality of life
arm group label: Control
arm group type: Active Comparator
description: Pulmonary Vein Antrum Isolation (PVAI) + isolation of left atrial posterior wall
arm group label: Study I
arm group type: Active Comparator
description: PVAI+ scar homogenization
arm group label: Study II
arm group type: Active Comparator
description: PVAI + isolation of left atrial posterior wall + non-PV triggers ablation
intervention type: Procedure
intervention name: Pulmonary Vein Antrum Isolation
description: Radio-frequency catheter ablation of pulmonary vein antrum extended to the left atrial posterior wall
arm group label: Control
arm group label: Study I
arm group label: Study II
other name: PVAI
intervention type: Procedure
intervention name: scar homogenization
description: PVAI + RF energy will be delivered until all abnormal potentials in the low-voltage areas are eliminated.
arm group label: Study I
arm group label: Study II
intervention type: Procedure
intervention name: Non-PV triggers ablation
description: PVAI + Isolation of LA posterior wall + Catheter ablation of triggers originating from extra-PV sites
arm group label: Study 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: Mitra Mohanty, MD
email: mitra.mohanty@stdavids.com
facility: 
status: 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: Recurrence