<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/NCT01696344</url>
  </required_header>
  <id_info>
    <org_study_id>TCAI_TARGET</org_study_id>
    <nct_id>NCT01696344</nct_id>
  </id_info>
  <brief_title>Does Atrial Fibrillation (AF) Termination Without Additional Ablation Influence Outcome?</brief_title>
  <acronym>TARGET</acronym>
  <official_title>Does AF Termination Without Additional Ablation Influence Outcome?</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective study aims to investigate if termination of atrial fibrillation (AF) after&#xD;
      pulmonary vein antrum isolation (PVAI) without additional ablation of non-PV triggers, in&#xD;
      long-standing persistent (LSP) AF, is enough to ensure long-term success.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: AF is a heterogeneous arrhythmia. At its simplest, it is triggered by rapidly&#xD;
      firing foci around pulmonary veins (PV) and can be cured by isolation of PV alone. Evidences&#xD;
      suggest that when high frequency of atrial activation is maintained for relatively longer&#xD;
      period (as in persistent or long-standing AF), ion channel remodeling changes the&#xD;
      electrophysiologic substrate and lead to AF permanence. Therefore, PVAI alone, as&#xD;
      anticipated, demonstrates to have limited success rate in persistent and LSP AF and&#xD;
      additional ablations beyond PVAI involving substrate modification are advocated by many&#xD;
      experts in electrophysiology. However, there is yet no consensus on the ablation strategy for&#xD;
      long-standing AF. It is still not clear whether AF termination during ablation could be&#xD;
      considered as an ablation endpoint or not, as earlier studies have reported results that are&#xD;
      at variance with each other. Some studies have suggested that termination of AF during&#xD;
      ablation is associated with reduced recurrence of arrhythmia while others detected no&#xD;
      association of AF termination with long-term maintenance of sinus rhythm (SR) in persistent&#xD;
      or LSP-AF.Therefore this study aims to examine ablation outcomes in LSP-AF patients with AF&#xD;
      termination with or without additional ablation of extra-PV triggers.&#xD;
&#xD;
      Hypothesis: AF termination does not eliminate the need for additional ablations in achieving&#xD;
      long-term ablation success in LSP-AF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>May 2012</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>AF recurrence</measure>
    <time_frame>3 years</time_frame>
    <description>Any episode of AF/AT 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_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <description>No additional ablation after AF termination(PVAI only)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <description>Additional ablation of extra-PV triggers before and after isoproterenol-challenge after AF termination (PVAI + ablation of extra-PV triggers)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PVAI</intervention_name>
    <arm_group_label>Cohort 1</arm_group_label>
    <other_name>Pulmonary vein antrum isolation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PVAI + ablation of extraPV triggers</intervention_name>
    <description>PVAI followed by ablation of extra-PV triggers originating from sites other than pulmonary veins such as superior vena cava, ligament of Marshall, coronary sinus, crista terminalis, left atrial (LA) posterior wall and LA appendage</description>
    <arm_group_label>Cohort 2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Drug-refractory long-standing persistent atrial fibrillation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years&#xD;
&#xD;
          2. LSP-AF patients experiencing AF termination during ablation&#xD;
&#xD;
          3. Ability to understand and provide signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous left atrial 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>
  <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>
  </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>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 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>LSPAF</keyword>
  <keyword>AF termination</keyword>
  <keyword>PVAI</keyword>
  <keyword>nonPV triggers</keyword>
  <keyword>Long-standing persistent</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>Undecided</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/NCT01696344
org study id: TCAI_TARGET
nct id: NCT01696344
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This prospective study aims to investigate if termination of atrial fibrillation (AF) after
      pulmonary vein antrum isolation (PVAI) without additional ablation of non-PV triggers, in
      long-standing persistent (LSP) AF, is enough to ensure long-term success.
Background: AF is a heterogeneous arrhythmia. At its simplest, it is triggered by rapidly
      firing foci around pulmonary veins (PV) and can be cured by isolation of PV alone. Evidences
      suggest that when high frequency of atrial activation is maintained for relatively longer
      period (as in persistent or long-standing AF), ion channel remodeling changes the
      electrophysiologic substrate and lead to AF permanence. Therefore, PVAI alone, as
      anticipated, demonstrates to have limited success rate in persistent and LSP AF and
      additional ablations beyond PVAI involving substrate modification are advocated by many
      experts in electrophysiology. However, there is yet no consensus on the ablation strategy for
      long-standing AF. It is still not clear whether AF termination during ablation could be
      considered as an ablation endpoint or not, as earlier studies have reported results that are
      at variance with each other. Some studies have suggested that termination of AF during
      ablation is associated with reduced recurrence of arrhythmia while others detected no
      association of AF termination with long-term maintenance of sinus rhythm (SR) in persistent
      or LSP-AF.Therefore this study aims to examine ablation outcomes in LSP-AF patients with AF
      termination with or without additional ablation of extra-PV triggers.

      Hypothesis: AF termination does not eliminate the need for additional ablations in achieving
      long-term ablation success in LSP-AF.
observational model: Cohort
time perspective: Prospective
measure: AF recurrence
time frame: 3 years
description: Any episode of AF/AT 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: Cohort 1
description: No additional ablation after AF termination(PVAI only)
arm group label: Cohort 2
description: Additional ablation of extra-PV triggers before and after isoproterenol-challenge after AF termination (PVAI + ablation of extra-PV triggers)
intervention type: Procedure
intervention name: PVAI
arm group label: Cohort 1
other name: Pulmonary vein antrum isolation
intervention type: Procedure
intervention name: PVAI + ablation of extraPV triggers
description: PVAI followed by ablation of extra-PV triggers originating from sites other than pulmonary veins such as superior vena cava, ligament of Marshall, coronary sinus, crista terminalis, left atrial (LA) posterior wall and LA appendage
arm group label: Cohort 2
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Andrea Natale, MD
role: Principal Investigator
affiliation: TCAI
facility: 
facility: 
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
sharing ipd: Undecided