<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/NCT03759912</url>
  </required_header>
  <id_info>
    <org_study_id>2018-07-008</org_study_id>
    <nct_id>NCT03759912</nct_id>
  </id_info>
  <brief_title>Ultra-High-Resolution Mapping Guided Partial Antral Ablation for AF</brief_title>
  <acronym>TAILOR</acronym>
  <official_title>The Efficacy of Ultra-High-Resolution Mapping Guided Partial Antral Ablation for Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Keimyung University Dongsan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Keimyung University Dongsan Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The electrical isolation of the pulmonary veins (PVI) is the cornerstone of current ablation&#xD;
      techniques for the treatment of atrial fibrillation (AF) because the PV is the most common&#xD;
      trigger of AF. Wide bi-antral circumferential ablation (WACA) is more effective than&#xD;
      segmental PV isolation in achieving freedom from total atrial tachyarrhythmia recurrence at&#xD;
      long-term follow-up. Therefore, it is widely accepted as initial ablation strategy. However,&#xD;
      the WACA technique requires a much larger number of ablation and higher energy to achieve&#xD;
      complete isolation because of thick atrial myocardial sleeves with multiple muscle layers&#xD;
      present in most of the PV antrum, which is less likely to achieve homogenous transmural&#xD;
      lesions in the entire circumference with the currently available ablation technologies.&#xD;
      Meanwhile, muscular discontinuities and abrupt changes of the fiber orientation in human&#xD;
      PV-Left atrium (LA) junction are previously reported, and electrical PV isolation can usually&#xD;
      be achieved without complete circumferential ablation. However, the current electroanatomical&#xD;
      mapping (EAM) system has a limitation to understand the complex relationship of PV-LA&#xD;
      junction mainly due to relatively low resolution.&#xD;
&#xD;
      The Rhythmia mapping system (BostonScientific, Inc, Cambridge, MA) is a new system provides&#xD;
      ultra-high-resolution EAM using a small basket array of 64 electrodes (IntellaMap Orion,&#xD;
      Boston Scientific). Owing to better resolution, this new system capable of rapidly and&#xD;
      accurately identify critical isthmuses and low-voltage regions of interest and also allows&#xD;
      automatic acquisition and accurate annotation of the electrograms, without the need for&#xD;
      manual correction.&#xD;
&#xD;
      In this context, we hypothesized that rapid and precise identification of activation pattern&#xD;
      of PV-LA junction by Rhythmia system could allow complete, durable electrical isolation of&#xD;
      PVs without circumferential antral ablation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The trial stopped prematurely because of enrollment challenges.&#xD;
  </why_stopped>
  <start_date type="Actual">November 20, 2018</start_date>
  <completion_date type="Actual">August 7, 2021</completion_date>
  <primary_completion_date type="Actual">August 5, 2020</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>Atrial arrhythmia recurrence</measure>
    <time_frame>one year</time_frame>
    <description>recurrence of atrial tachyarrhythmia after the index procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>acute pulmonary vein isolation rate</measure>
    <time_frame>During procedure</time_frame>
    <description>Percentage of patients who are able to obtain pulmonary vein isolation during the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>acute pulmonary vein reconnection rate</measure>
    <time_frame>During procedure</time_frame>
    <description>Percentage of patients who achieve pulmonary vein isolation during the procedure but have PV reconnection within the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentage of ablation area in the antrum</measure>
    <time_frame>During procedure</time_frame>
    <description>Area of pulmonary vein antrum ablated to obtain pulmonary vein isolation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural outcome</measure>
    <time_frame>During procedure</time_frame>
    <description>procedure time in minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural outcome</measure>
    <time_frame>During procedure</time_frame>
    <description>fluoroscopic time in minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural outcome</measure>
    <time_frame>During procedure</time_frame>
    <description>total ablation time in minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural outcome</measure>
    <time_frame>During procedure</time_frame>
    <description>procedural complications - number of patients who experienced complications</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">75</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>PVI using Ultra-High-Resolution Mapping</arm_group_label>
    <description>The paroxysmal atrial fibrillation patients who received pulmonary vein antral catheter ablation for electrical isolation of pulmonary veins using ultra-high-resolution mapping system (Rhythmia High Density mapping system).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Paroxysmal atrial fibrillation patients who received pulmonary vein isolation using&#xD;
        Rhythmia HDx mapping system in Keimyung University Dongsan Medical Center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age over 20 years old and under 80 years old&#xD;
&#xD;
          2. Patients with non-valvular paroxysmal atrial fibrillation&#xD;
&#xD;
          3. Patients having atrial fibrillation even after receiving continued treatment with at&#xD;
             least 1 antiarrhythmic drug for more than 6 weeks&#xD;
&#xD;
          4. Patients who could have informed consent&#xD;
&#xD;
          5. Patients who are available for a follow-up of more than at least three months after&#xD;
             the catheter ablation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients unsuitable for catheter ablation due to a previous history of pulmonary&#xD;
             surgery or structural heart disease&#xD;
&#xD;
          2. Patients who cannot receive standard treatments such as anticoagulation therapy needed&#xD;
             before the radiofrequency catheter ablation&#xD;
&#xD;
          3. Patients in the subject group vulnerable to a clinical study&#xD;
&#xD;
          4. Patients who had undergone a prior catheter ablation for atrial fibrillation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seongwook Han, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Keimyung University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Keimyung University Dongsan Medical Center</name>
      <address>
        <city>Daegu</city>
        <zip>41931</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>May 27, 2023</last_update_submitted>
  <last_update_submitted_qc>May 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Keimyung University Dongsan Medical Center</investigator_affiliation>
    <investigator_full_name>Seongwook Han</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Atrial fibrillation ablation</keyword>
  <keyword>Pulmonary vein</keyword>
  <keyword>Ultra high resolution mapping</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</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/NCT03759912
org study id: 2018-07-008
nct id: NCT03759912
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The electrical isolation of the pulmonary veins (PVI) is the cornerstone of current ablation
      techniques for the treatment of atrial fibrillation (AF) because the PV is the most common
      trigger of AF. Wide bi-antral circumferential ablation (WACA) is more effective than
      segmental PV isolation in achieving freedom from total atrial tachyarrhythmia recurrence at
      long-term follow-up. Therefore, it is widely accepted as initial ablation strategy. However,
      the WACA technique requires a much larger number of ablation and higher energy to achieve
      complete isolation because of thick atrial myocardial sleeves with multiple muscle layers
      present in most of the PV antrum, which is less likely to achieve homogenous transmural
      lesions in the entire circumference with the currently available ablation technologies.
      Meanwhile, muscular discontinuities and abrupt changes of the fiber orientation in human
      PV-Left atrium (LA) junction are previously reported, and electrical PV isolation can usually
      be achieved without complete circumferential ablation. However, the current electroanatomical
      mapping (EAM) system has a limitation to understand the complex relationship of PV-LA
      junction mainly due to relatively low resolution.

      The Rhythmia mapping system (BostonScientific, Inc, Cambridge, MA) is a new system provides
      ultra-high-resolution EAM using a small basket array of 64 electrodes (IntellaMap Orion,
      Boston Scientific). Owing to better resolution, this new system capable of rapidly and
      accurately identify critical isthmuses and low-voltage regions of interest and also allows
      automatic acquisition and accurate annotation of the electrograms, without the need for
      manual correction.

      In this context, we hypothesized that rapid and precise identification of activation pattern
      of PV-LA junction by Rhythmia system could allow complete, durable electrical isolation of
      PVs without circumferential antral ablation.
observational model: Cohort
time perspective: Prospective
measure: Atrial arrhythmia recurrence
time frame: one year
description: recurrence of atrial tachyarrhythmia after the index procedure
measure: acute pulmonary vein isolation rate
time frame: During procedure
description: Percentage of patients who are able to obtain pulmonary vein isolation during the procedure
measure: acute pulmonary vein reconnection rate
time frame: During procedure
description: Percentage of patients who achieve pulmonary vein isolation during the procedure but have PV reconnection within the procedure
measure: percentage of ablation area in the antrum
time frame: During procedure
description: Area of pulmonary vein antrum ablated to obtain pulmonary vein isolation
measure: Procedural outcome
time frame: During procedure
description: procedure time in minute
measure: Procedural outcome
time frame: During procedure
description: fluoroscopic time in minute
measure: Procedural outcome
time frame: During procedure
description: total ablation time in minute
measure: Procedural outcome
time frame: During procedure
description: procedural complications - number of patients who experienced complications
arm group label: PVI using Ultra-High-Resolution Mapping
description: The paroxysmal atrial fibrillation patients who received pulmonary vein antral catheter ablation for electrical isolation of pulmonary veins using ultra-high-resolution mapping system (Rhythmia High Density mapping system).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Seongwook Han, MD, PhD
role: Principal Investigator
affiliation: Keimyung University
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Keimyung University Dongsan Medical Center
investigator full name: Seongwook Han
investigator title: Professor
mesh term: Atrial Fibrillation