<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/NCT01677052</url>
  </required_header>
  <id_info>
    <org_study_id>STR-148</org_study_id>
    <nct_id>NCT01677052</nct_id>
  </id_info>
  <brief_title>THERMOCOOL® SMARTTOUCH™ Registry</brief_title>
  <official_title>THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Atrial Fibrillation- Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biosense Webster, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biosense Webster, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this registry is to obtain &quot;real world&quot; clinical use of contact force&#xD;
      measurements during ablation procedures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Acute Success</measure>
    <time_frame>1 year</time_frame>
    <description>Confirmation of entrance block in the pulmonary veins (acute success)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Contact Force</measure>
    <time_frame>1 year</time_frame>
    <description>Contact force during ablation procedures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>1 year</time_frame>
    <description>Procedural complications and adverse events throughout the registry</description>
  </primary_outcome>
  <enrollment type="Actual">426</enrollment>
  <condition>Symptomatic Atrial Fibrillation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Target enrollment for this registry is 650 subjects. Of the 650 subjects enrolled, at least&#xD;
        250 will have paroxysmal atrial fibrillation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with symptomatic atrial fibrillation (AF) who, in the opinion of the&#xD;
             investigator, are candidates for ablation for atrial fibrillation. Candidates who have&#xD;
             had previous ablation procedures may be included in the registry&#xD;
&#xD;
          -  Subjects who have failed at least one antiarrhythmic drug (AAD)(class I or III, or AV&#xD;
             nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced&#xD;
             by recurrent symptomatic atrial fibrillation, or intolerable to the AAD.&#xD;
&#xD;
          -  Subjects must be 18 years of age or older&#xD;
&#xD;
          -  Subjects must be able and willing to comply with all pre-, post and follow-up testing&#xD;
             and requirements&#xD;
&#xD;
          -  Subjects must provide written informed consent to participate in the registry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant congenital anomaly or a medical problem that in the opinion of the&#xD;
             investigator would preclude enrollment in this registry&#xD;
&#xD;
          -  History of blood clotting or bleeding abnormalities or contraindication to&#xD;
             anticoagulation (heparin, warfarin, or dabigatran)&#xD;
&#xD;
          -  History of a documented thromboembolic event within the past year&#xD;
&#xD;
          -  Significant pulmonary disease (eg, restrictive pulmonary disease, constrictive or&#xD;
             chronic obstructive pulmonary disease)or any other disease or malfunction of the lungs&#xD;
             or respiratory system that produces chronic symptoms&#xD;
&#xD;
          -  Previous cardiac surgery (eg, CABG) or valvular cardiac surgical procedure (eg,&#xD;
             ventriculotomy, atriotomy, valve repair or replacement, presence of a prosthetic&#xD;
             valve)&#xD;
&#xD;
          -  Awaiting cardiac transplantation or other cardiac surgery within the next 360 days (12&#xD;
             months)&#xD;
&#xD;
          -  Diagnosed atrial myxoma&#xD;
&#xD;
          -  Unstable angina&#xD;
&#xD;
          -  Uncontrolled heart failure Uncontrolled heart Failure or NYHA Class III or IV heart&#xD;
             failure&#xD;
&#xD;
          -  Acute illness, active systemic infection, or sepsis&#xD;
&#xD;
          -  Any other disease or malfunction that would preclude treatment with ablation in the&#xD;
             opinion of the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Adelaide/Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Melbourne Health/Royal Melbourne Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Andrew's Hospital</name>
      <address>
        <city>Adelaide</city>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Prince Charles Hospital</name>
      <address>
        <city>Adelaide</city>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OLV Hospital Aalst Cardiovascular Center</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Brugmann</name>
      <address>
        <city>Brussels</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Brussels</city>
        <zip>1090-B</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Oost-Limburg, Genk</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southlake Regional Health Centre</name>
      <address>
        <city>Newmarket</city>
        <state>Ontario</state>
        <zip>L3Y 2P9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <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>
    <facility>
      <name>Hopital Laval</name>
      <address>
        <city>Quebec</city>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Hopital Prive de Parly II</name>
      <address>
        <city>Le Chesnay</city>
        <zip>78150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Rangueil Toulouse</name>
      <address>
        <city>Toulouse Cedex</city>
        <zip>50032</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Infirmerie Protestante</name>
      <address>
        <city>Villeurbanne</city>
        <zip>69100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herz-und GefaB-Klinik, Bad Neustadt</name>
      <address>
        <city>Bad Neustadt</city>
        <zip>97616</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite Campus Mitte</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helios Klinikum Berlin-Buch</name>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik St. Georg</name>
      <address>
        <city>Hamburg</city>
        <zip>20099</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ludwig Maximilian University of Munich</name>
      <address>
        <city>Munich</city>
        <zip>80539</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Miulli</name>
      <address>
        <city>Acquaviva delle Fonti</city>
        <zip>70021</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASL no. 6</name>
      <address>
        <city>Cirie (TO)</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Manzoni di Lecco</name>
      <address>
        <city>Lecco</city>
        <zip>23900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Giacomo and Cristoforo Hospital</name>
      <address>
        <city>Massa</city>
        <zip>54100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Princesse Grace</name>
      <address>
        <city>Monte Carlo</city>
        <zip>98000</zip>
        <country>Monaco</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Bournemouth Hospital</name>
      <address>
        <city>Bournemouth</city>
        <zip>BH7 7DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bristol Heart Institute</name>
      <address>
        <city>Bristol</city>
        <zip>BS2 8HW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Papworth Hospital</name>
      <address>
        <city>Cambridge</city>
        <zip>CB23 3RE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glenfield Hospital, Leicester</name>
      <address>
        <city>Leicester</city>
        <zip>LE3 9QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Thomas' Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Monaco</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>September 24, 2014</last_update_submitted>
  <last_update_submitted_qc>September 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT01677052
org study id: STR-148
nct id: NCT01677052
lead sponsor: 
has dmc: Yes
The primary purpose of this registry is to obtain "real world" clinical use of contact force
      measurements during ablation procedures.
time perspective: Prospective
measure: Acute Success
time frame: 1 year
description: Confirmation of entrance block in the pulmonary veins (acute success)
measure: Contact Force
time frame: 1 year
description: Contact force during ablation procedures
measure: Adverse Events
time frame: 1 year
description: Procedural complications and adverse events throughout the registry
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Australia
country: Belgium
country: Canada
country: France
country: Germany
country: Italy
country: Monaco
country: United Kingdom
responsible party type: Sponsor
mesh term: Atrial Fibrillation