<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/NCT01693107</url>
  </required_header>
  <id_info>
    <org_study_id>Version 20120423</org_study_id>
    <nct_id>NCT01693107</nct_id>
  </id_info>
  <brief_title>Atrial Fibrillation Force Contact Ablation Study</brief_title>
  <acronym>CAFCAS</acronym>
  <official_title>The Canadian Atrial Fibrillation Force Contact Ablation Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be divided into two phases. The purpose of the Phase I registry is to assess&#xD;
      the current force being used for ablation of symptomatic paroxysmal AF in a wide range of&#xD;
      operators in different Canadian centres with the operators being blinded to the contact force&#xD;
      data.&#xD;
&#xD;
      In Phase II of the study, operators will have open use of the force contact data. Phase I and&#xD;
      II data will be compared in order to assess the efficiency of using the THERMOCOOL®&#xD;
      SMARTTOUCH™ catheter.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Atrial fibrillation (AF) is the most common arrhythmia affecting over 5% of the population&#xD;
      above the age of 65 years. The use of percutaneous catheter ablation for symptomatic&#xD;
      management has increased over the last decade. It is well established that AF ablation is&#xD;
      superior to anti-arrhythmic drugs for symptomatic recurrence of AF. Despite this, success&#xD;
      rates with a single procedure for paroxysmal AF is approximately 80% with the majority of&#xD;
      recurrence due to recovery of lesions or &quot;gaps&quot; found at repeat procedures.&#xD;
&#xD;
      In this study, patients with symptomatic paroxysmal atrial fibrillation (AF) will undergo&#xD;
      ablation using a newly Health Canada approved catheter with SmartTouch technology that&#xD;
      enables the measurement of catheter tip contact force and direction inside the heart. The&#xD;
      purpose of Phase I of the study is to assess the current force being used for ablation of&#xD;
      symptomatic paroxysmal AF in a wide range of operators in different Canadian centres with the&#xD;
      operators being blinded to the contact force data.&#xD;
&#xD;
      The secondary objective will be to assess whether lesion recovery, as assessed in redo&#xD;
      procedures, corresponds to contact force measurements. It is hypothesized that gaps found on&#xD;
      repeat procedures will correspond to ablation lesions associated with a lower contact force.&#xD;
&#xD;
      In Phase II, operators will have open use of the force contact data. Phase I and II data will&#xD;
      be compared in order to assess the efficiency of using the SmartTouch catheter. It is&#xD;
      hypothesized that the open use of contact force data will decrease the procedural time and&#xD;
      number of lesions to achieve bidirectional pulmonary vein isolation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Procedural Time</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 36 hours</time_frame>
    <description>Length of time between first ablation and last ablation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lesion Recovery</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Localization of recovered gaps</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ablation Time</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 36 hours</time_frame>
    <description>Total time of ablation used during procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ablation lesions</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 36 hours</time_frame>
    <description>Total number of ablation lesions to achieve bidirectional block of all 4 pulmonary veins</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Paroxysmal Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Operator Blinded to Contact Force</arm_group_label>
    <description>Physicians performing the ablation will be blinded to the contact force data</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with symptomatic paroxysmal atrial fibrillation who have failed antiarrhythmic&#xD;
        medications and scheduled for a pulmonary vein isolation procedure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 18 years or greater.&#xD;
&#xD;
          -  Patients undergoing first-time pulmonary vein catheter ablation for AF.&#xD;
&#xD;
          -  Patients with paroxysmal AF. Paroxysmal AF will be defined as symptomatic episodes of&#xD;
             AF lasting less than 7 days or treated with cardioversion(s) within 48 hours of onset.&#xD;
&#xD;
          -  At least one episode of AF must have been documented on telemetry, ambulatory monitor,&#xD;
             or 12-lead ECG.&#xD;
&#xD;
          -  Patients must be able and willing to provide written informed consent to participate&#xD;
             in the clinical study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of any previous ablation for atrial fibrillation.&#xD;
&#xD;
          -  Patients with a previous atriotomy scar, ie. Mitral or tricuspid valve replacement or&#xD;
             repair, ASD surgery, cardiac transplant.&#xD;
&#xD;
          -  Patients with an intracardiac thrombus&#xD;
&#xD;
          -  Patients who are or may potentially be pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Leong-Sit, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>March 27, 2020</last_update_submitted>
  <last_update_submitted_qc>March 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial Fibrillation</keyword>
  <keyword>Catheter Ablation</keyword>
  <keyword>Electrophysiology</keyword>
  <keyword>Cardiac Arrhythmias</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/NCT01693107
org study id: Version 20120423
nct id: NCT01693107
lead sponsor: 
has dmc: No
This study will be divided into two phases. The purpose of the Phase I registry is to assess
      the current force being used for ablation of symptomatic paroxysmal AF in a wide range of
      operators in different Canadian centres with the operators being blinded to the contact force
      data.

      In Phase II of the study, operators will have open use of the force contact data. Phase I and
      II data will be compared in order to assess the efficiency of using the THERMOCOOL®
      SMARTTOUCH™ catheter.
Atrial fibrillation (AF) is the most common arrhythmia affecting over 5% of the population
      above the age of 65 years. The use of percutaneous catheter ablation for symptomatic
      management has increased over the last decade. It is well established that AF ablation is
      superior to anti-arrhythmic drugs for symptomatic recurrence of AF. Despite this, success
      rates with a single procedure for paroxysmal AF is approximately 80% with the majority of
      recurrence due to recovery of lesions or "gaps" found at repeat procedures.

      In this study, patients with symptomatic paroxysmal atrial fibrillation (AF) will undergo
      ablation using a newly Health Canada approved catheter with SmartTouch technology that
      enables the measurement of catheter tip contact force and direction inside the heart. The
      purpose of Phase I of the study is to assess the current force being used for ablation of
      symptomatic paroxysmal AF in a wide range of operators in different Canadian centres with the
      operators being blinded to the contact force data.

      The secondary objective will be to assess whether lesion recovery, as assessed in redo
      procedures, corresponds to contact force measurements. It is hypothesized that gaps found on
      repeat procedures will correspond to ablation lesions associated with a lower contact force.

      In Phase II, operators will have open use of the force contact data. Phase I and II data will
      be compared in order to assess the efficiency of using the SmartTouch catheter. It is
      hypothesized that the open use of contact force data will decrease the procedural time and
      number of lesions to achieve bidirectional pulmonary vein isolation.
observational model: Cohort
time perspective: Prospective
measure: Procedural Time
time frame: participants will be followed for the duration of hospital stay, an expected average of 36 hours
description: Length of time between first ablation and last ablation
measure: Lesion Recovery
time frame: up to 1 year
description: Localization of recovered gaps
measure: Ablation Time
time frame: participants will be followed for the duration of hospital stay, an expected average of 36 hours
description: Total time of ablation used during procedure
measure: Number of ablation lesions
time frame: participants will be followed for the duration of hospital stay, an expected average of 36 hours
description: Total number of ablation lesions to achieve bidirectional block of all 4 pulmonary veins
arm group label: Operator Blinded to Contact Force
description: Physicians performing the ablation will be blinded to the contact force data
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Leong-Sit, MD
role: Principal Investigator
affiliation: Western University
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Atrial Fibrillation