<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/NCT02217657</url>
  </required_header>
  <id_info>
    <org_study_id>MucM001-13</org_study_id>
    <nct_id>NCT02217657</nct_id>
  </id_info>
  <brief_title>SmartTouch Catheter for Left Anterior Line - SmarT Line Study</brief_title>
  <official_title>&quot;Bidirectional Conduction Block of Left Atrial Anterior Line in Patients With Left Atrial Ablation - Reduction of RF Applications Using the Thermocool SmartTouch Contact Force Sensing Catheter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LMU Klinikum</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LMU Klinikum</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective, randomized study will investigate, if information of the catheter force&#xD;
      during ablation of a left anterior line does reduce total RF application time by prevention&#xD;
      of ineffective lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Catheter ablation has emerged as a realistic therapeutic option for symptomatic atrial&#xD;
      fibrillation (AF).&#xD;
&#xD;
      The three main techniques described for ablation of persistent AF include pulmonary vein (PV)&#xD;
      isolation, ablation based on electrogram analysis, and left atrial (LA) linear lesions.&#xD;
&#xD;
      The ideal endpoint of linear lesions should be complete electrical block; however, this is&#xD;
      technically challenging, time consuming, and potentially hazardous. The ST catheter combined&#xD;
      with 3D mapping and navigation software, gives physicians a real-time, objective measure of&#xD;
      tip-to-tissue contact force during the catheter ablation procedure and will allow physicians&#xD;
      to more safely and effectively treat atrial fibrillation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2013</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of total RF application until bidirectional conduction block across the anterior line is achieved (including a waiting period of 30 minutes)</measure>
    <time_frame>30 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Achievement of primary endpoint (bidirectional conduction block at an anterior line)</measure>
    <time_frame>6 months</time_frame>
    <description>Achievement of primary endpoint (bidirectional conduction block at an anterior line). Procedure Duration. Reduction of local potential amplitude during SR or atrial fibrillation after 60 seconds of ablation. Freedom of any atrial tachyarrhythmia at 7 day holter 3 and 6 months after a single ablation procedure. Freedom of any symptoms of atrial arrhythmias 6 months after ablation (except during blanking period of 6 weeks). Confirmation of gap-freeness in MRI (3-6 months after ablation). Quality of Life (atrial fibrillation symptom checklist und major depression index) pre, 3 and 6 months after Ablation. Safety (bleeding, pericardial effusion, thrombembolic events).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Persistent Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>operator informed to contact force</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Thermocool Smart Touch Catheter, operator informed to contact force (Biosense Webster)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>operator blinded to contact force</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thermocool Smart Touch catheter, operator blinded to contact force information (Biosense Webster)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Thermocool Smart Touch Catheter</intervention_name>
    <description>Physician informed to contact force</description>
    <arm_group_label>operator blinded to contact force</arm_group_label>
    <arm_group_label>operator informed to contact force</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with symptomatic atrial fibrillation and additional substrate modification or&#xD;
             perimitral flutter&#xD;
&#xD;
          -  Patients with persistent atrial fibrillation&#xD;
&#xD;
          -  Patients with perimitral flutter&#xD;
&#xD;
          -  Patients with recurrence after a circumferential PV isolation procedure&#xD;
&#xD;
          -  Patients with paroxysmal atrial fibrillation and AF episodes lasting &gt; 7 days&#xD;
&#xD;
          -  Patients (&gt;18 und &lt;80 Jahre)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  moderate to severe valvular heart disease,&#xD;
&#xD;
          -  congenital heart disease&#xD;
&#xD;
          -  reduced left ventricular function (ejection fraction &lt;35%)&#xD;
&#xD;
          -  any reversible cause for atrial fibrillation (e.g. hyperthyroidism)&#xD;
&#xD;
          -  intracardiac thrombi documented by transesophageal echocardiography&#xD;
&#xD;
          -  myocardial infarction within 3 months, cardiac surgery in the previous three months&#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>Heidi Estner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Munich University Clinic, Campus Großhadern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Munich University Clinic, Campus Großhadern</name>
      <address>
        <city>Munich</city>
        <state>Bavaria</state>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>February 23, 2021</last_update_submitted>
  <last_update_submitted_qc>February 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>LMU Klinikum</investigator_affiliation>
    <investigator_full_name>Heidi Estner</investigator_full_name>
    <investigator_title>Director Interventional Electrophysiology</investigator_title>
  </responsible_party>
  <keyword>Smart-Touch</keyword>
  <keyword>Contact force</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02217657
org study id: MucM001-13
nct id: NCT02217657
lead sponsor: 
has dmc: No
This prospective, randomized study will investigate, if information of the catheter force
      during ablation of a left anterior line does reduce total RF application time by prevention
      of ineffective lesions.
Catheter ablation has emerged as a realistic therapeutic option for symptomatic atrial
      fibrillation (AF).

      The three main techniques described for ablation of persistent AF include pulmonary vein (PV)
      isolation, ablation based on electrogram analysis, and left atrial (LA) linear lesions.

      The ideal endpoint of linear lesions should be complete electrical block; however, this is
      technically challenging, time consuming, and potentially hazardous. The ST catheter combined
      with 3D mapping and navigation software, gives physicians a real-time, objective measure of
      tip-to-tissue contact force during the catheter ablation procedure and will allow physicians
      to more safely and effectively treat atrial fibrillation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Duration of total RF application until bidirectional conduction block across the anterior line is achieved (including a waiting period of 30 minutes)
time frame: 30 minutes
measure: Achievement of primary endpoint (bidirectional conduction block at an anterior line)
time frame: 6 months
description: Achievement of primary endpoint (bidirectional conduction block at an anterior line). Procedure Duration. Reduction of local potential amplitude during SR or atrial fibrillation after 60 seconds of ablation. Freedom of any atrial tachyarrhythmia at 7 day holter 3 and 6 months after a single ablation procedure. Freedom of any symptoms of atrial arrhythmias 6 months after ablation (except during blanking period of 6 weeks). Confirmation of gap-freeness in MRI (3-6 months after ablation). Quality of Life (atrial fibrillation symptom checklist und major depression index) pre, 3 and 6 months after Ablation. Safety (bleeding, pericardial effusion, thrombembolic events).
arm group label: operator informed to contact force
arm group type: Active Comparator
description: Thermocool Smart Touch Catheter, operator informed to contact force (Biosense Webster)
arm group label: operator blinded to contact force
arm group type: Experimental
description: Thermocool Smart Touch catheter, operator blinded to contact force information (Biosense Webster)
intervention type: Device
intervention name: Thermocool Smart Touch Catheter
description: Physician informed to contact force
arm group label: operator blinded to contact force
arm group label: operator informed to contact force
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Heidi Estner, MD
role: Principal Investigator
affiliation: Munich University Clinic, Campus Großhadern
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: LMU Klinikum
investigator full name: Heidi Estner
investigator title: Director Interventional Electrophysiology
mesh term: Atrial Fibrillation
sharing ipd: No