<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/NCT01730924</url>
  </required_header>
  <id_info>
    <org_study_id>008205 QM</org_study_id>
    <nct_id>NCT01730924</nct_id>
  </id_info>
  <brief_title>Comparison of Pulmonary Vein Isolation Using SmartTouch® Catheter With or Without Real-time Contact Force Data</brief_title>
  <official_title>A Randomised Study Comparing Pulmonary Vein Isolation Using SmartTouch® Catheter With or Without Real-time Contact Force Data. The SMART Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen Mary University of London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Queen Mary University of London</source>
  <brief_summary>
    <textblock>
      The most widely used approach for the invasive treatment of paroxysmal atrial fibrillation is&#xD;
      catheter ablation, by which radiofrequency energy is used to heat the tip of an ablation&#xD;
      catheter to deliver targeted burns on the inner surface of the heart. The aim of this&#xD;
      approach is to cause electrical isolation of the pulmonary veins. The purpose of this study&#xD;
      is to evaluate whether the information which can be derived from the latest catheter&#xD;
      technologies - on the degree of contact force between the catheter and the heart - affects&#xD;
      the time to perform the procedure, or the outcomes as a result of it. Patients undergoing&#xD;
      pulmonary vein isolation will be randomised to having their procedure performed with the&#xD;
      contact force information available to the operator, or not available. The time taken to&#xD;
      achieve pulmonary vein isolation is the primary end-point of the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <primary_completion_date type="Actual">December 2014</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>
    <primary_purpose>Treatment</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Time to achieve pulmonary vein isolation in patients undergoing catheter ablation for paroxysmal atrial fibrillaiton</measure>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Atrial Fibrillation Ablation</condition>
  <condition>Pulmonary Vein Isolation</condition>
  <arm_group>
    <arm_group_label>Contact force available</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Contact force not available</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pulmonary vein isolation using contact force sensing catheter</intervention_name>
    <arm_group_label>Contact force available</arm_group_label>
    <arm_group_label>Contact force not available</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Age &gt; 18 years, Symptomatic paroxysmal atrial fibrillation (defined as ECG proven episodes&#xD;
        of atrial fibrillation which are self limiting and last less than 7 days on each occasion)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Inability or unwillingness to receive oral anticoagulation Previous ablation procedure for&#xD;
        atrial fibrillation Unwillingness or inability to complete the required follow up&#xD;
        arrangements Persistent atrial fibrillation Prior prosthetic mitral valve replacement or&#xD;
        severe structural cardiac abnormality Known severe left ventricular systolic function&#xD;
        (ejection fraction &lt;35%) Known hypertrophic or infiltrative cardiomyopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Barts Health NHS Trust</name>
      <address>
        <city>London</city>
        <zip>EC1A 7BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>September 28, 2016</last_update_submitted>
  <last_update_submitted_qc>September 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Queen Mary University of London</investigator_affiliation>
    <investigator_full_name>Prof Richard Schilling</investigator_full_name>
    <investigator_title>Professor of Cardiology</investigator_title>
  </responsible_party>
  <keyword>Atrial fibrillation</keyword>
  <keyword>Contact force</keyword>
  <keyword>Ablation</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/NCT01730924
org study id: 008205 QM
nct id: NCT01730924
lead sponsor: 
The most widely used approach for the invasive treatment of paroxysmal atrial fibrillation is
      catheter ablation, by which radiofrequency energy is used to heat the tip of an ablation
      catheter to deliver targeted burns on the inner surface of the heart. The aim of this
      approach is to cause electrical isolation of the pulmonary veins. The purpose of this study
      is to evaluate whether the information which can be derived from the latest catheter
      technologies - on the degree of contact force between the catheter and the heart - affects
      the time to perform the procedure, or the outcomes as a result of it. Patients undergoing
      pulmonary vein isolation will be randomised to having their procedure performed with the
      contact force information available to the operator, or not available. The time taken to
      achieve pulmonary vein isolation is the primary end-point of the study.
allocation: Randomized
primary purpose: Treatment
measure: Time to achieve pulmonary vein isolation in patients undergoing catheter ablation for paroxysmal atrial fibrillaiton
arm group label: Contact force available
arm group type: Other
arm group label: Contact force not available
arm group type: Other
intervention type: Procedure
intervention name: Pulmonary vein isolation using contact force sensing catheter
arm group label: Contact force available
arm group label: Contact force not available
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Queen Mary University of London
investigator full name: Prof Richard Schilling
investigator title: Professor of Cardiology
mesh term: Atrial Fibrillation