<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/NCT02991313</url>
  </required_header>
  <id_info>
    <org_study_id>LME-167</org_study_id>
    <nct_id>NCT02991313</nct_id>
  </id_info>
  <brief_title>Evaluation of a Multi-electrode Linear Type Catheter (D-1368-01-SI)</brief_title>
  <official_title>Evaluation of a Multi-electrode Linear Type Catheter (D-1368-01-SI) for Endocardial Ablation of Patients With Persistent Atrial Fibrillation (LME-167)</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this trial is to assess acute safety and performance of the Multi-electrode&#xD;
      Linear Type Catheter in conjunction with generator software V2.4.0 or above when used for the&#xD;
      treatment of Persistent Atrial Fibrillation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</primary_completion_date>
  <phase>N/A</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>Early Onset of Primary Adverse Events</measure>
    <time_frame>Within 7 days</time_frame>
    <description>Incidence of early onset (within 7 days of ablation procedure) primary Adverse Events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Confirmation of entrance block</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Acute procedural success defined as: Confirmation of entrance block in all targeted PVs after adenosine and /or isoproterenol challenge (taking into account a 30 minute waiting period from the last RF application at a PV target before verification)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Confirmation of bi-directional block</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Acute procedural success defined as: Confirmation of bi-directional block in all linear lesions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Serious Adverse Device Effects (SADEs)</measure>
    <time_frame>1 Year</time_frame>
    <description>Incidence of Serious Adverse Device Effects (SADEs) during follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia</measure>
    <time_frame>3, 6 and 12 months post-procedure</time_frame>
    <description>Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia recurrence at 3, 6 and 12 months post-procedure</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Persistent Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Endocardial Ablation Procedure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ablation with Linear type catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Endocardial Ablation Procedure</intervention_name>
    <arm_group_label>Endocardial Ablation Procedure</arm_group_label>
    <other_name>Linear Type Catheter (D-1368-01-SI)</other_name>
    <other_name>nMARQ TM Multi-channel RF generator (D-1341-07) with Software V2.4.0 or above</other_name>
    <other_name>Linear Ablation Connection Cable (M-5948-01-I)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt; 18 years.&#xD;
&#xD;
          2. Signed the Patient Informed Consent Form (ICF)&#xD;
&#xD;
          3. Documented ongoing or previous symptomatic persistent AF (by physician's note&#xD;
             indicating continuous AF ≥ 7 days)&#xD;
&#xD;
          4. Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by&#xD;
             recurrent symptomatic AF, or intolerable to the AAD.&#xD;
&#xD;
          5. Able and willing to comply with all pre-, post-, and follow-up testing and&#xD;
             requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous surgical or catheter ablation for atrial fibrillation&#xD;
&#xD;
          2. Current condition of continuous AF &gt; 12 months (1 year) (Longstanding Persistent AF)&#xD;
             or previously diagnosed as having Longstanding Persistent AF&#xD;
&#xD;
          3. Any carotid stenting or endarterectomy&#xD;
&#xD;
          4. Known with Cardioversion refractory history (the inability to restore sinus rhythm for&#xD;
             30 secs or longer following electrical cardioversion.&#xD;
&#xD;
          5. LA size &gt; 55 mm&#xD;
&#xD;
          6. LVEF &lt;40%&#xD;
&#xD;
          7. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac&#xD;
             cause&#xD;
&#xD;
          8. Significant pulmonary disease (i.e. restrictive pulmonary disease, constrictive or&#xD;
             chronic obstructive pulmonary disease) or any other disease or malfunction of the&#xD;
             lungs or respiratory system that produces chronic symptoms&#xD;
&#xD;
          9. Uncontrolled heart failure or NYHA function class III and IV&#xD;
&#xD;
         10. MI within the past 2 months&#xD;
&#xD;
         11. Any cardiac surgery (i.e. CABG) within the past 2 months&#xD;
&#xD;
         12. Subjects that have ever undergone valvular cardiac surgical/ percutaneous procedure&#xD;
             (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a&#xD;
             prosthetic valve)&#xD;
&#xD;
         13. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months&#xD;
&#xD;
         14. Documented thromboembolic event (including TIA) within the past 12 months&#xD;
&#xD;
         15. Significant congenital anomaly or medical problem that in the opinion of the&#xD;
             investigator would preclude enrollment in this study&#xD;
&#xD;
         16. Active illness or active systemic infection or sepsis&#xD;
&#xD;
         17. Unstable angina&#xD;
&#xD;
         18. History of blood clotting or bleeding abnormalities&#xD;
&#xD;
         19. Contraindication to anticoagulation (eg, heparin or warfarin)&#xD;
&#xD;
         20. Life expectancy less than 12 months&#xD;
&#xD;
         21. Presence of intracardiac thrombus, myxoma, interatrial baffle or patch, tumor or other&#xD;
             abnormality that precludes catheter introduction or manipulation&#xD;
&#xD;
         22. Presence of a condition that precludes vascular access&#xD;
&#xD;
         23. Women of child bearing potential whom are pregnant, lactating, or planning to become&#xD;
             pregnant during the course of the clinical investigation&#xD;
&#xD;
         24. Currently enrolled in another device, biologics, or drug study&#xD;
&#xD;
         25. Contraindication for use of the investigational devices , 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>
  <location>
    <facility>
      <name>Ospedale Generale Regionale &quot;F. Miulli&quot;</name>
      <address>
        <city>Sant'Eramo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Giovanni Battista Molinette</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glenfield Hospital</name>
      <address>
        <city>Leicester</city>
        <zip>LE3 9QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Thomas' Hospital London</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>April 29, 2019</last_update_submitted>
  <last_update_submitted_qc>April 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2019</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/NCT02991313
org study id: LME-167
nct id: NCT02991313
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this trial is to assess acute safety and performance of the Multi-electrode
      Linear Type Catheter in conjunction with generator software V2.4.0 or above when used for the
      treatment of Persistent Atrial Fibrillation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Early Onset of Primary Adverse Events
time frame: Within 7 days
description: Incidence of early onset (within 7 days of ablation procedure) primary Adverse Events
measure: Confirmation of entrance block
time frame: Intraoperative
description: Acute procedural success defined as: Confirmation of entrance block in all targeted PVs after adenosine and /or isoproterenol challenge (taking into account a 30 minute waiting period from the last RF application at a PV target before verification)
measure: Confirmation of bi-directional block
time frame: Intraoperative
description: Acute procedural success defined as: Confirmation of bi-directional block in all linear lesions
measure: Incidence of Serious Adverse Device Effects (SADEs)
time frame: 1 Year
description: Incidence of Serious Adverse Device Effects (SADEs) during follow-up
measure: Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia
time frame: 3, 6 and 12 months post-procedure
description: Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia recurrence at 3, 6 and 12 months post-procedure
arm group label: Endocardial Ablation Procedure
arm group type: Experimental
description: ablation with Linear type catheter
intervention type: Device
intervention name: Endocardial Ablation Procedure
arm group label: Endocardial Ablation Procedure
other name: Linear Type Catheter (D-1368-01-SI)
other name: nMARQ TM Multi-channel RF generator (D-1341-07) with Software V2.4.0 or above
other name: Linear Ablation Connection Cable (M-5948-01-I)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: Italy
country: United Kingdom
responsible party type: Sponsor
mesh term: Atrial Fibrillation