<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/NCT02184013</url>
  </required_header>
  <id_info>
    <org_study_id>20140623</org_study_id>
    <nct_id>NCT02184013</nct_id>
  </id_info>
  <brief_title>Correlation of the Arrhythmia Mechanism and Substrate to Ablate Persistent Atrial Fibrillation Study</brief_title>
  <acronym>COAST-AF</acronym>
  <official_title>Correlation of Arrhythmia Mechanism and Substrate to Ablate Persistent Atrial Fibrillation:A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Heart Institute Research Corporation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Heart Institute Research Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study to assess the usefulness of ECG mapping, and enhanced MRI and PET scan&#xD;
      imaging in identifying atrial fibrosis and arrhythmia circuits involved in persistent atrial&#xD;
      fibrillation and in guiding an innovative AF catheter ablation strategy.&#xD;
&#xD;
      It is hypothesized that identifying these critical arrhythmia circuits and atrial fibrosis&#xD;
      with enhanced imaging and performing an individualized innovative AF catheter ablation will&#xD;
      result in higher procedural success rates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pulmonary vein isolation catheter ablation for the treatment of persistent AF (PeAF)or&#xD;
      longstanding persistent AF is associated with success rates of 40-50% at one year.&#xD;
      Experimental models have shown that AF results in progressive structural changes due to&#xD;
      electrical atrial remodeling, where AF burden correlates with atrial fibrosis. The optimal&#xD;
      ablation strategy for patients with PeAF is not yet known. There is limited understanding of&#xD;
      the critical mechanisms responsible for maintenance of AF in these patients.&#xD;
&#xD;
      In this study ECG body mapping (ECGI) will be used to look for distinct electrical rotors in&#xD;
      the atria. Delayed gadolinium enhanced magnetic resonance imaging (DE-MRI) will be used to&#xD;
      assess the extent of left atrial fibrosis. In addition to PVI catheter ablation procedure, an&#xD;
      ablation strategy guided by the results of the ECGI mapping and DE-MRI will be performed.A&#xD;
      C-metahydroxyepherdrine (HED) PET scan will also be done pre-ablation to evaluate left atrial&#xD;
      sympathetic denervation and any relationship to the initiation and/or maintenance of AF.&#xD;
&#xD;
      Subjects will be seen at 3 and 6 months after ablation, with 12 lead ECG and 2-week loop&#xD;
      monitoring done at each visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>August 2015</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Atrial Fibrillation (AF) Termination</measure>
    <time_frame>During catheter ablation</time_frame>
    <description>AF termination resulting in restoration of sinus rhythm during ablation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radio frequency (RF) ablation time</measure>
    <time_frame>During catheter ablation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure Duration</measure>
    <time_frame>During catheter ablation</time_frame>
    <description>Total procedure duration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from AF</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">52</enrollment>
  <condition>Persistent Atrial Fibrillation</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Catheter ablation</intervention_name>
    <description>Catheter ablation (in addition ot PVI) guided by ECGI mapping, and atrial fibrosis mapping (DE-MRI).</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years and ≤ 80 years;&#xD;
&#xD;
          -  Symptomatic persistent AF AND clinically indicated for AF catheter ablation&#xD;
&#xD;
          -  At least one episode of AF lasting more than 7 days, documented on 12-lead ECG, Holter&#xD;
             monitor, 2-week loop monitor or trans-telephonic monitor (TTM) within 12 months of&#xD;
             enrollment in the study&#xD;
&#xD;
          -  Able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of previous catheter or surgical ablation for AF&#xD;
&#xD;
          -  Presence of intracardiac thrombus&#xD;
&#xD;
          -  contraindication to systemic oral anticoagulation therapy&#xD;
&#xD;
          -  Subjects with reversible causes of AF&#xD;
&#xD;
          -  Antero-posterior left atrial dimension &gt; 60 mm on echocardiography&#xD;
&#xD;
          -  Severe valvular disease (mitral/aortic stenosis or regurgitation);&#xD;
&#xD;
          -  Subjects that are pregnant or breastfeeding;&#xD;
&#xD;
          -  Chronic kidney disease and creatinine clearance &lt;50ml/min.&#xD;
&#xD;
          -  Contraindication to MRI Imaging (e.g. permanent pacemaker, metallic implants, 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>Pablo B Nery, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Heart Institute Research Corporation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert deKemp, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Heart Institute Research Corporation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elena Pena, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Ottawa Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David H Birnie, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Heart Institute Research Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Ottawa Heart Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4W7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>March 3, 2023</last_update_submitted>
  <last_update_submitted_qc>March 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial fibrillation</keyword>
  <keyword>Catheter ablation</keyword>
  <keyword>Delayed gadolinium enhanced MRI</keyword>
  <keyword>C-metahydroxyepherdrine (HED) PET scan</keyword>
  <keyword>ECGI mapping</keyword>
  <keyword>Atrial Fibrosis</keyword>
  <keyword>Atrial sympathetic denervation</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/NCT02184013
org study id: 20140623
nct id: NCT02184013
lead sponsor: 
has dmc: Yes
This is a pilot study to assess the usefulness of ECG mapping, and enhanced MRI and PET scan
      imaging in identifying atrial fibrosis and arrhythmia circuits involved in persistent atrial
      fibrillation and in guiding an innovative AF catheter ablation strategy.

      It is hypothesized that identifying these critical arrhythmia circuits and atrial fibrosis
      with enhanced imaging and performing an individualized innovative AF catheter ablation will
      result in higher procedural success rates.
Pulmonary vein isolation catheter ablation for the treatment of persistent AF (PeAF)or
      longstanding persistent AF is associated with success rates of 40-50% at one year.
      Experimental models have shown that AF results in progressive structural changes due to
      electrical atrial remodeling, where AF burden correlates with atrial fibrosis. The optimal
      ablation strategy for patients with PeAF is not yet known. There is limited understanding of
      the critical mechanisms responsible for maintenance of AF in these patients.

      In this study ECG body mapping (ECGI) will be used to look for distinct electrical rotors in
      the atria. Delayed gadolinium enhanced magnetic resonance imaging (DE-MRI) will be used to
      assess the extent of left atrial fibrosis. In addition to PVI catheter ablation procedure, an
      ablation strategy guided by the results of the ECGI mapping and DE-MRI will be performed.A
      C-metahydroxyepherdrine (HED) PET scan will also be done pre-ablation to evaluate left atrial
      sympathetic denervation and any relationship to the initiation and/or maintenance of AF.

      Subjects will be seen at 3 and 6 months after ablation, with 12 lead ECG and 2-week loop
      monitoring done at each visit.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Atrial Fibrillation (AF) Termination
time frame: During catheter ablation
description: AF termination resulting in restoration of sinus rhythm during ablation.
measure: Radio frequency (RF) ablation time
time frame: During catheter ablation
measure: Procedure Duration
time frame: During catheter ablation
description: Total procedure duration
measure: Freedom from AF
time frame: 6 months
intervention type: Procedure
intervention name: Catheter ablation
description: Catheter ablation (in addition ot PVI) guided by ECGI mapping, and atrial fibrosis mapping (DE-MRI).
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Pablo B Nery, MD
role: Principal Investigator
affiliation: Ottawa Heart Institute Research Corporation
last name: Robert deKemp, PhD
role: Principal Investigator
affiliation: Ottawa Heart Institute Research Corporation
last name: Elena Pena, MD
role: Principal Investigator
affiliation: The Ottawa Hospital
last name: David H Birnie, MD
role: Principal Investigator
affiliation: Ottawa Heart Institute Research Corporation
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Atrial Fibrillation