<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/NCT01730807</url>
  </required_header>
  <id_info>
    <org_study_id>MiFi-CTI</org_study_id>
    <nct_id>NCT01730807</nct_id>
  </id_info>
  <brief_title>IntellaTip MiFi XP Ablation Catheter Trial</brief_title>
  <acronym>MiFi-CTI</acronym>
  <official_title>IntellaTip MiFi XP Ablation Catheters First in Human Use Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study to assess the performance of a new catheter design for the treatment of Atrial&#xD;
      Flutter.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, non-blinded, single arm, single center study designed to assess the&#xD;
      performance of the IntellaTip MiFi XP Ablation Catheter for the treatment of recurrent or&#xD;
      sustained type I atrial Flutter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">February 2014</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>Acute Procedural Success</measure>
    <time_frame>one day</time_frame>
    <description>The Demonstration of bi-directional isthmus block at the end of the ablation procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complication Rate at procedure</measure>
    <time_frame>7 days</time_frame>
    <description>Determine major complications in patients exposed to the device, which occur within 7 days of the procedure</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Atrial Flutter</condition>
  <arm_group>
    <arm_group_label>IntellaTip XP MiFi</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with Atrial Flutter will receive ablation treatment with the IntellaTip MiFi XP catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IntellaTip MiFi XP Catheter</intervention_name>
    <description>Temperature controlled ablation catheter</description>
    <arm_group_label>IntellaTip XP MiFi</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 or older&#xD;
&#xD;
          -  indicated for ablation for Atrial Flutter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Thrombus&#xD;
&#xD;
          -  Recent MI/cardiac revascularization&#xD;
&#xD;
          -  Prosthetic Valves&#xD;
&#xD;
          -  recent ablation for atrial flutter&#xD;
&#xD;
          -  atrial flutter with reversible cause&#xD;
&#xD;
          -  Class IV HF&#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>Prashanthan Sanders, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Adelaide Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5001</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>November 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>May 2, 2017</last_update_submitted>
  <last_update_submitted_qc>May 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial Flutter</keyword>
  <keyword>Ablation</keyword>
  <keyword>Type I Atrial Flutter</keyword>
  <keyword>Atrial Arrhythmia</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/NCT01730807
org study id: MiFi-CTI
nct id: NCT01730807
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A study to assess the performance of a new catheter design for the treatment of Atrial
      Flutter.
A prospective, non-blinded, single arm, single center study designed to assess the
      performance of the IntellaTip MiFi XP Ablation Catheter for the treatment of recurrent or
      sustained type I atrial Flutter.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Acute Procedural Success
time frame: one day
description: The Demonstration of bi-directional isthmus block at the end of the ablation procedure
measure: Complication Rate at procedure
time frame: 7 days
description: Determine major complications in patients exposed to the device, which occur within 7 days of the procedure
arm group label: IntellaTip XP MiFi
arm group type: Experimental
description: Patients with Atrial Flutter will receive ablation treatment with the IntellaTip MiFi XP catheter
intervention type: Device
intervention name: IntellaTip MiFi XP Catheter
description: Temperature controlled ablation catheter
arm group label: IntellaTip XP MiFi
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Prashanthan Sanders, MD
role: Principal Investigator
affiliation: Royal Adelaide Hospital
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Atrial Flutter