<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/NCT04434599</url>
  </required_header>
  <id_info>
    <org_study_id>281105</org_study_id>
    <nct_id>NCT04434599</nct_id>
  </id_info>
  <brief_title>Fluoroscopic, Contact Force and Local Impedance With Ultra-high Density Mapping Guided Radiofrequency Ablation Comparison for cavoTricuspid Isthmus dependenT Atrial fluttER: the FLUTTER Study</brief_title>
  <acronym>FLUTTER</acronym>
  <official_title>Fluoroscopic, Contact Force and Local Impedance With Ultra-high Density Mapping Guided Radiofrequency Ablation Comparison for cavoTricuspid Isthmus dependenT Atrial fluttER: the FLUTTER Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Manchester University NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Manchester</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Catheter ablation is a first-line treatment for patients with cavotricuspid isthmus (CTI)&#xD;
      dependent atrial flutter (AFL; also known as typical AFL), a common arrhythmia. This is done&#xD;
      using radiofrequency (RF) catheters and single-procedure success is approximately 95%.&#xD;
      Ablation is often done using one of three methods:&#xD;
&#xD;
        1. fluoroscopically, using X-rays to guide the operator to visualise catheter position&#xD;
           within the heart. This method involves the most radiation exposure to patient and&#xD;
           operator. Ablation is generally performed for a set time-period (eg. 30-60secs) to&#xD;
           ensure each ablation lesion is successful.&#xD;
&#xD;
        2. using a 3-dimensional mapping system which allows the catheters to be magnetically&#xD;
           located and visualised on a monitor without X-rays, and using &quot;contact force&quot; (CF)&#xD;
           sensing catheters. This requires minimal X-ray use, and by ensuring a minimum degree of&#xD;
           force between catheter tip and the heart before applying RF for a set time-period (eg.&#xD;
           30 seconds), operators can be more confident of successful lesions.&#xD;
&#xD;
        3. using an ultra-high density mapping system which uses magnetic tracking as above, but&#xD;
           allows higher resolution visualisation of the cardiac electrical system with potential&#xD;
           for improving procedure success; this has not yet been formally evaluated for AFL.&#xD;
           Catheters using this method use &quot;local impedance&quot; (LI) instead of CF. This is a direct&#xD;
           measure of heart tissue impedance with real-time changes during ablation. A minimum drop&#xD;
           or plateau in the LI value during ablation allows confidence of lesion success, without&#xD;
           the need to ablate for a pre-defined time-period. This could potentially reduce ablation&#xD;
           time and subsequent complications, but has also not yet been formally compared to the&#xD;
           above for this indication.&#xD;
&#xD;
      This prospective randomised study aims to compare these three standard of care procedures to&#xD;
      determine if differences in ablation metrics, efficacy and safety exist.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">October 30, 2022</start_date>
  <completion_date type="Anticipated">January 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2023</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>
    <intervention_model_description>114 patients randomised 1:1:1 to either fluoroscopically guided OR contact force guided OR local impedance guided radiofrequency catheter ablation of typical atrial flutter</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time from first application of radiofrequency energy to confirmation of bidirectional cavotricuspid isthmus block</measure>
    <time_frame>At time of procedure</time_frame>
    <description>Time from first application of radiofrequency energy to confirmation of bidirectional cavotricuspid isthmus block</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean total ablation time to achieve bidirectional cavotricuspid isthmus block</measure>
    <time_frame>At time of procedure</time_frame>
    <description>Mean total ablation time to achieve bidirectional cavotricuspid isthmus block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean total radiation exposure</measure>
    <time_frame>At time of procedure</time_frame>
    <description>Mean total radiation exposure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean total number of ablation lesions required to achieve bidirectional cavotricuspid isthmus block</measure>
    <time_frame>At time of procedure</time_frame>
    <description>Mean total number of ablation lesions required to achieve bidirectional cavotricuspid isthmus block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cases where bidirectional cavotricuspid isthmus block was not achieved after the first pass of ablation</measure>
    <time_frame>At time of procedure</time_frame>
    <description>Number of cases where bidirectional cavotricuspid isthmus block was not achieved after the first pass of ablation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean time taken for second pass ablation (with or without the use of 3D mapping) to achieve bidirectional cavotricuspid isthmus block</measure>
    <time_frame>At time of procedure</time_frame>
    <description>Mean time taken for second pass ablation (with or without the use of 3D mapping) to achieve bidirectional cavotricuspid isthmus block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Locations of breakthrough across the initial ablation line</measure>
    <time_frame>At time of procedure</time_frame>
    <description>Locations of breakthrough across the initial ablation line</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of procedural complications</measure>
    <time_frame>At time of and immediately following procedure</time_frame>
    <description>Frequency of procedural complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute and medium-term success rates</measure>
    <time_frame>12 months</time_frame>
    <description>Acute and medium-term success rates</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">114</enrollment>
  <condition>Typical Atrial Flutter</condition>
  <arm_group>
    <arm_group_label>Fluoroscopically guided ablation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>These patients will receive one catheter ablation of typical atrial flutter by fluoroscopically guided radiofrequency ablation catheters</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Contact force guided ablation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>These patients will receive one catheter ablation of typical atrial flutter by contact force guided radiofrequency ablation catheters using the CARTO 3D electroanatomic mapping system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Local impedance guided ablation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>These patients will receive one catheter ablation of typical atrial flutter by local impedence guided radiofrequency ablation catheters using the Rhythmia Ultra-high density 3D electroanatomic mapping system</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fluoroscopically guided ablation</intervention_name>
    <description>Catheter ablation of the cavotricuspid isthmus using ablation catheters guided by fluoroscopy</description>
    <arm_group_label>Fluoroscopically guided ablation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Contact force guided ablation</intervention_name>
    <description>Catheter ablation of the cavotricuspid isthmus using ablation catheters guided by contact force measurement and 3D electroanatomic mapping</description>
    <arm_group_label>Contact force guided ablation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Local impedance guide ablation</intervention_name>
    <description>Catheter ablation of the cavotricuspid isthmus using ablation catheters guided by local impedance measurement and ultra-high density 3D electroanatomic mapping</description>
    <arm_group_label>Local impedance guided ablation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients under the care of the NHS&#xD;
&#xD;
          -  Aged 18-80 years&#xD;
&#xD;
          -  Symptoms and 12-lead ECG suggestive of typical (cavotricuspid isthmus dependent)&#xD;
             atrial flutter&#xD;
&#xD;
          -  Due to undergo first-time cavotricuspid isthmus ablation (including as part of a&#xD;
             combined ablation if also having pulmonary vein isolation for atrial fibrillation) on&#xD;
             clinical grounds&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Pre-procedure:&#xD;
&#xD;
          -  Inability to given informed consent / lack of mental capacity&#xD;
&#xD;
          -  Obesity (BMI &gt;40)&#xD;
&#xD;
          -  Congenital heart disease or tricuspid valve abnormalities likely to prolong procedure&#xD;
             time, including Ebstein anomaly, atrial septal defects, tricuspid valve repair or&#xD;
             replacement, severe tricuspid valve regurgitation&#xD;
&#xD;
          -  Inability or unwillingness to receive oral anticoagulation with a vitamin K antagonist&#xD;
             (VKA) or non-VKA oral anticoagulant (NOAC)&#xD;
&#xD;
          -  Previous cavotricuspid isthmus ablation procedure&#xD;
&#xD;
          -  Known infiltrative cardiomyopathy&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Age &lt; 18 or &gt;80&#xD;
&#xD;
          -  Inability to speak adequate English/need for an interpreter for study consent process&#xD;
&#xD;
        Post procedure:&#xD;
&#xD;
        - arrhythmia mechanism found not to be cavotricuspid isthmus dependent atrial flutter&#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_contact>
    <last_name>Karan Saraf, MBChB MRCP(UK)</last_name>
    <phone>+441612761234</phone>
    <email>karan.saraf@mft.nhs.uk</email>
  </overall_contact>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>August 24, 2022</last_update_submitted>
  <last_update_submitted_qc>August 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manchester</investigator_affiliation>
    <investigator_full_name>Karan Saraf</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <keyword>radiofrequency ablation</keyword>
  <keyword>contact force</keyword>
  <keyword>local impedance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Flutter</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/NCT04434599
org study id: 281105
nct id: NCT04434599
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Catheter ablation is a first-line treatment for patients with cavotricuspid isthmus (CTI)
      dependent atrial flutter (AFL; also known as typical AFL), a common arrhythmia. This is done
      using radiofrequency (RF) catheters and single-procedure success is approximately 95%.
      Ablation is often done using one of three methods:

        1. fluoroscopically, using X-rays to guide the operator to visualise catheter position
           within the heart. This method involves the most radiation exposure to patient and
           operator. Ablation is generally performed for a set time-period (eg. 30-60secs) to
           ensure each ablation lesion is successful.

        2. using a 3-dimensional mapping system which allows the catheters to be magnetically
           located and visualised on a monitor without X-rays, and using "contact force" (CF)
           sensing catheters. This requires minimal X-ray use, and by ensuring a minimum degree of
           force between catheter tip and the heart before applying RF for a set time-period (eg.
           30 seconds), operators can be more confident of successful lesions.

        3. using an ultra-high density mapping system which uses magnetic tracking as above, but
           allows higher resolution visualisation of the cardiac electrical system with potential
           for improving procedure success; this has not yet been formally evaluated for AFL.
           Catheters using this method use "local impedance" (LI) instead of CF. This is a direct
           measure of heart tissue impedance with real-time changes during ablation. A minimum drop
           or plateau in the LI value during ablation allows confidence of lesion success, without
           the need to ablate for a pre-defined time-period. This could potentially reduce ablation
           time and subsequent complications, but has also not yet been formally compared to the
           above for this indication.

      This prospective randomised study aims to compare these three standard of care procedures to
      determine if differences in ablation metrics, efficacy and safety exist.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 114 patients randomised 1:1:1 to either fluoroscopically guided OR contact force guided OR local impedance guided radiofrequency catheter ablation of typical atrial flutter
primary purpose: Treatment
masking: None (Open Label)
measure: Time from first application of radiofrequency energy to confirmation of bidirectional cavotricuspid isthmus block
time frame: At time of procedure
description: Time from first application of radiofrequency energy to confirmation of bidirectional cavotricuspid isthmus block
measure: Mean total ablation time to achieve bidirectional cavotricuspid isthmus block
time frame: At time of procedure
description: Mean total ablation time to achieve bidirectional cavotricuspid isthmus block
measure: Mean total radiation exposure
time frame: At time of procedure
description: Mean total radiation exposure
measure: Mean total number of ablation lesions required to achieve bidirectional cavotricuspid isthmus block
time frame: At time of procedure
description: Mean total number of ablation lesions required to achieve bidirectional cavotricuspid isthmus block
measure: Number of cases where bidirectional cavotricuspid isthmus block was not achieved after the first pass of ablation
time frame: At time of procedure
description: Number of cases where bidirectional cavotricuspid isthmus block was not achieved after the first pass of ablation
measure: Mean time taken for second pass ablation (with or without the use of 3D mapping) to achieve bidirectional cavotricuspid isthmus block
time frame: At time of procedure
description: Mean time taken for second pass ablation (with or without the use of 3D mapping) to achieve bidirectional cavotricuspid isthmus block
measure: Locations of breakthrough across the initial ablation line
time frame: At time of procedure
description: Locations of breakthrough across the initial ablation line
measure: Frequency of procedural complications
time frame: At time of and immediately following procedure
description: Frequency of procedural complications
measure: Acute and medium-term success rates
time frame: 12 months
description: Acute and medium-term success rates
arm group label: Fluoroscopically guided ablation
arm group type: Active Comparator
description: These patients will receive one catheter ablation of typical atrial flutter by fluoroscopically guided radiofrequency ablation catheters
arm group label: Contact force guided ablation
arm group type: Active Comparator
description: These patients will receive one catheter ablation of typical atrial flutter by contact force guided radiofrequency ablation catheters using the CARTO 3D electroanatomic mapping system
arm group label: Local impedance guided ablation
arm group type: Active Comparator
description: These patients will receive one catheter ablation of typical atrial flutter by local impedence guided radiofrequency ablation catheters using the Rhythmia Ultra-high density 3D electroanatomic mapping system
intervention type: Device
intervention name: Fluoroscopically guided ablation
description: Catheter ablation of the cavotricuspid isthmus using ablation catheters guided by fluoroscopy
arm group label: Fluoroscopically guided ablation
intervention type: Device
intervention name: Contact force guided ablation
description: Catheter ablation of the cavotricuspid isthmus using ablation catheters guided by contact force measurement and 3D electroanatomic mapping
arm group label: Contact force guided ablation
intervention type: Device
intervention name: Local impedance guide ablation
description: Catheter ablation of the cavotricuspid isthmus using ablation catheters guided by local impedance measurement and ultra-high density 3D electroanatomic mapping
arm group label: Local impedance guided ablation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Karan Saraf, MBChB MRCP(UK)
phone: +441612761234
email: karan.saraf@mft.nhs.uk
responsible party type: Principal Investigator
investigator affiliation: University of Manchester
investigator full name: Karan Saraf
investigator title: Investigator
mesh term: Atrial Flutter
sharing ipd: No