<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/NCT02257060</url>
  </required_header>
  <id_info>
    <org_study_id>LINEAR II</org_study_id>
    <nct_id>NCT02257060</nct_id>
  </id_info>
  <brief_title>LINEAR II - LME-159 Evaluation of a Multi-Electrode Linear Type Ablation Catheter</brief_title>
  <official_title>Evaluation of a Multi-Electrode Linear Type Ablation Catheter for Endocardial Ablation of Patients With Right Atrial Flutter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biosense Webster, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biosense Webster, Inc.</source>
  <brief_summary>
    <textblock>
      The Linear II study is a prospective, single center, non-randomized, interventional&#xD;
      feasibility study with the purpose of assessing acute safety of the Multi-Electrode Linear&#xD;
      Type Ablation Catheter and the performance of the product when used for the treatment of&#xD;
      symptomatic CTI (cavotricuspid isthmus) dependent right atrial flutter.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 1</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>Safety</measure>
    <time_frame>7 Days</time_frame>
    <description>Incidence of early onset (within 7 days of ablation procedure) primary AEs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute performance</measure>
    <time_frame>This outcome measure will be assessed during the procedure but after 30 minutes (or more) of the initial ablation</time_frame>
    <description>Acute procedural success as confirmed complete bidirectional conduction block across the CTI (assess ≥30 min following last RF application)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>Until one-month follow-up</time_frame>
    <description>Incidence of Serious Adverse Events during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute Efficacy</measure>
    <time_frame>Within 30 Days</time_frame>
    <description>Right atrial flutter recurrence within 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural data</measure>
    <time_frame>During Procedure</time_frame>
    <description>Ablation parameters, including:&#xD;
Total RF ablation time&#xD;
Temperature&#xD;
Contact Force Procedural time Total fluoroscopy time</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Cavotricuspid Isthmus Dependent Right Atrial Flutter</condition>
  <arm_group>
    <arm_group_label>Endocardial Ablation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endocardial Ablation</intervention_name>
    <arm_group_label>Endocardial Ablation</arm_group_label>
    <other_name>Radiofrequency (RF) ablation with the</other_name>
    <other_name>- Linear Type Ablation Catheter</other_name>
    <other_name>- nMARQ™ Multi-Channel RF Generator with Software V2.4.0</other_name>
    <other_name>- Linear Ablation Connection Cable</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least one symptomatic episode of typical CTI dependent right atrial flutter&#xD;
             documented by 12 lead ECG, Holter monitor, transtelephonic event monitor, telemetry&#xD;
             strip, or implanted device.&#xD;
&#xD;
          -  Age 18 years or older.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous typical CTI dependent right atrial flutter ablation&#xD;
&#xD;
          -  Uncontrolled heart failure or NYHA function class IV&#xD;
&#xD;
          -  MI within the past 2 months&#xD;
&#xD;
          -  Any cardiac surgery (i.e. CABG) within the past 2 months&#xD;
&#xD;
          -  Subjects that have ever undergone valvular cardiac surgical procedure (ie,&#xD;
             ventriculotomy, atriotomy, and valve repair or replacement and presence of a&#xD;
             prosthetic valve)&#xD;
&#xD;
          -  Awaiting cardiac transplantation or other cardiac surgery within the next 6 months&#xD;
&#xD;
          -  Documented thromboembolic event (including TIA) within the past 12 months&#xD;
&#xD;
          -  Significant congenital anomaly or medical problem that in the opinion of the&#xD;
             investigator would preclude enrollment in this study&#xD;
&#xD;
          -  Active illness or active systemic infection or sepsis&#xD;
&#xD;
          -  Unstable angina&#xD;
&#xD;
          -  History of blood clotting or bleeding abnormalities&#xD;
&#xD;
          -  Contraindication to anticoagulation (eg, heparin or warfarin)&#xD;
&#xD;
          -  Life expectancy less than 6 months&#xD;
&#xD;
          -  Presence of intracardiac thrombus, myxoma, interatrial baffle or patch, tumor or other&#xD;
             abnormality that precludes catheter introduction or manipulation&#xD;
&#xD;
          -  Presence of a condition that precludes vascular access&#xD;
&#xD;
          -  Women of child bearing potential whom are pregnant, lactating, or planning to become&#xD;
             pregnant during the course of the clinical investigation&#xD;
&#xD;
          -  Currently enrolled in another device, biologics, or drug study&#xD;
&#xD;
          -  Contraindication for use of the investigational catheter, as indicated in the&#xD;
             respective Instructions For Use&#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>Massimo Grimaldi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Miulli Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Miulli Hospital</name>
      <address>
        <city>Acquaviva Delle Fonti</city>
        <state>Bari/Strada</state>
        <zip>70021</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>June 24, 2015</last_update_submitted>
  <last_update_submitted_qc>June 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 25, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Endocardial Ablation</keyword>
  <keyword>Atrial Flutter</keyword>
  <keyword>Cavotricuspid Isthmus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Flutter</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/NCT02257060
org study id: LINEAR II
nct id: NCT02257060
lead sponsor: 
The Linear II study is a prospective, single center, non-randomized, interventional
      feasibility study with the purpose of assessing acute safety of the Multi-Electrode Linear
      Type Ablation Catheter and the performance of the product when used for the treatment of
      symptomatic CTI (cavotricuspid isthmus) dependent right atrial flutter.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety
time frame: 7 Days
description: Incidence of early onset (within 7 days of ablation procedure) primary AEs
measure: Acute performance
time frame: This outcome measure will be assessed during the procedure but after 30 minutes (or more) of the initial ablation
description: Acute procedural success as confirmed complete bidirectional conduction block across the CTI (assess ≥30 min following last RF application)
measure: Safety
time frame: Until one-month follow-up
description: Incidence of Serious Adverse Events during follow-up
measure: Acute Efficacy
time frame: Within 30 Days
description: Right atrial flutter recurrence within 30 days
measure: Procedural data
time frame: During Procedure
description: Ablation parameters, including:
Total RF ablation time
Temperature
Contact Force Procedural time Total fluoroscopy time
arm group label: Endocardial Ablation
arm group type: Experimental
intervention type: Procedure
intervention name: Endocardial Ablation
arm group label: Endocardial Ablation
other name: Radiofrequency (RF) ablation with the
other name: - Linear Type Ablation Catheter
other name: - nMARQ™ Multi-Channel RF Generator with Software V2.4.0
other name: - Linear Ablation Connection Cable
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Massimo Grimaldi
role: Principal Investigator
affiliation: Miulli Hospital
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Atrial Flutter