<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/NCT02968147</url>
  </required_header>
  <id_info>
    <org_study_id>PID11559</org_study_id>
    <nct_id>NCT02968147</nct_id>
  </id_info>
  <brief_title>High Frequency Jet Ventilation in AF Ablation</brief_title>
  <official_title>High Frequency Jet Ventilation in AF Ablation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oxford University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oxford University Hospitals NHS Trust</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>
      Atrial fibrillation (AF) is a cardiac condition that results in patients experiencing an&#xD;
      irregular heart beat resulting in symptoms including palpitations and breathlessness. It is&#xD;
      known that in most cases, AF is caused by abnormal electrical activity from the top of the&#xD;
      left side of the heart (left atrium) which overrides the heart natural pacemaker in the right&#xD;
      atrium. Treatment options include tablets which suppress this abnormal electrical activity,&#xD;
      but in some patients these are not sufficient and a procedure is carried out where the areas&#xD;
      of abnormal electrical activity are disconnected or 'ablated' to prevent AF from occurring.&#xD;
      This treatment is well established and performed worldwide, often under general anaesthetic&#xD;
      (GA). The heart and lungs sit close together in the chest, and when the lungs are inflated&#xD;
      and deflated during the procedure, the heart also moves. This movement is then transmitted to&#xD;
      the special wires or 'catheters' that are placed inside the heart to deliver the ablation&#xD;
      treatment. Instability during the treatment can result in ineffective areas of ablation which&#xD;
      may later contribute to reduced success of the procedure. Previous research has shown that by&#xD;
      reducing the movement of the heart under anaesthesia using alternative techniques can improve&#xD;
      catheter stability and improve procedural results. Once such technique is called high&#xD;
      frequency jet ventilation (HFJV) which allows the lungs to filled with air using fast and&#xD;
      shallow breaths resulting in normal blood oxygen levels with little movement in the heart.&#xD;
      This technique has been shown to be safe and effective for this procedure but a direct&#xD;
      comparison with conventional ventilation has not been done. The investigators wish to test&#xD;
      this and determine if using HFJV improves outcomes during the procedure (i.e. can&#xD;
      investigators do the treatment faster and more effectively) and if this translates to better&#xD;
      outcomes long term.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Catheter ablation for the treatment of the symptoms of fibrillation is now a well-established&#xD;
      technique. The technique is complex and commonly undertaken under general anaesthesia.&#xD;
      Catheters are introduced into the circulation from the veins at the top of the leg and&#xD;
      advanced to the right side of the heart. Using x-ray and ultrasound guidance, the catheters&#xD;
      are passed to the left atrium by puncturing the muscle that divides left and right atria&#xD;
      (septum). A model of the left atrium is created and this used to guide the movement of an&#xD;
      ablation catheter across the tissue and create ablation lesions that lead to electrical&#xD;
      isolation of target sites.&#xD;
&#xD;
      Under general anaesthesia, the lungs are inflated and deflated via the ventilator circuit.&#xD;
      The expansion of the lungs results in movement of the heart with each respiratory cycle. This&#xD;
      leads to catheter instability as the tissue is moved towards and away from a catheter&#xD;
      positioned in the left atrium. This movement is particularly marked at the back of the left&#xD;
      atrium. This instability can lead to real time variation in the delivery of energy which can&#xD;
      result in ineffective lesions. These will then translate acutely to incomplete isolation and&#xD;
      the need for further ablation (thereby increasing procedure time) and later into reconnection&#xD;
      of tissue which can result in repeated procedures being needed to achieve an effective&#xD;
      outcome. Each procedure carries risk of minor and major complications therefore measures to&#xD;
      improve first time success are critical.&#xD;
&#xD;
      Current research supports the use of steerable catheter sheaths (tubes through which the&#xD;
      catheters travel to the atria) and 3 dimensional mapping in improving ablation parameters.&#xD;
      Data also exists demonstrating significant variation in catheter contact despite these&#xD;
      measures. In order to improve catheter stability further, changes to the mode of ventilation&#xD;
      has been studied. Small studies have shown that by stopping cardiac movement altogether by&#xD;
      transiently stopping ventilation (apnoea) catheter stability is improved and ablation is more&#xD;
      effective. However, intermittent apnoea is not an effective method of ventilation in long&#xD;
      cases. An alternative is high frequency jet ventilation. This is where the lungs are&#xD;
      ventilated with low volume, high speed and high pressure breaths. This technique is well&#xD;
      established and has safety data in upper airway surgery and liver radiology procedures where&#xD;
      movement of airways and diaphragm needs to be minimized. In view of this, this technique has&#xD;
      been studied in AF ablation and has been shown to improve catheter stability and energy&#xD;
      delivery with no increase in complications related to the mode of ventilation. However,&#xD;
      existing studies have focused mainly in paroxysmal AF patients (where less ablation is&#xD;
      needed) and conducted in a non randomized trial design.&#xD;
&#xD;
      The investigators wish to research the use of HFJV in patients undergoing ablation for&#xD;
      persistent AF in a prospective and randomised trial to answer the primary and secondary&#xD;
      questions shown below.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 7, 2017</start_date>
  <completion_date type="Actual">May 31, 2019</completion_date>
  <primary_completion_date type="Actual">November 7, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with improved catheter contact force during AF ablation under high frequency jet ventilation</measure>
    <time_frame>12 months</time_frame>
    <description>Data will be extracted from the St Jude Medical Velocity/Tacticath system to determine average force (grams/sec) for each applied lesion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with improved lesion power delivery during AF ablation under high frequency jet ventilation</measure>
    <time_frame>12 months</time_frame>
    <description>Data will be extracted from the St Jude Medical Velocity/Tacticath system to determine power delivery (force time integral) for each applied lesion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with improved lesion creation during AF ablation under high frequency jet ventilation</measure>
    <time_frame>12 months</time_frame>
    <description>Data will be extracted from the St Jude Medical Velocity/Tacticath system to determine power delivery (lesion size index) for each applied lesion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with improved catheter stability during AF ablation under high frequency jet ventilation</measure>
    <time_frame>12 months</time_frame>
    <description>Data will be extracted from the St Jude Medical Velocity/Tacticath system to determine catheter movement (mm movement during ablation) for each applied lesion.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Conventional ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Catheter ablation for persistent atrial fibrillation with general anesthesia and conventional ventilation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Jet ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Catheter ablation for persistent atrial fibrillation with general anesthesia and high frequency jet ventilation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High frequency jet ventilation</intervention_name>
    <description>General anaesthesia and ventilation with the Acutronic Monsoon III Jet ventilator system</description>
    <arm_group_label>Jet ventilation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional ventilation</intervention_name>
    <description>General anaesthesia and ventilation with a conventional Phillips intermittent positive pressure ventilator system</description>
    <arm_group_label>Conventional ventilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is willing and able to give informed consent for participation in the&#xD;
             study.&#xD;
&#xD;
          -  Male or Female, aged 18 years or above.&#xD;
&#xD;
          -  Indication for left atrial catheter ablation for persistent atrial fibrillation&#xD;
&#xD;
          -  Patients may be enrolled in other atrial fibrillation trials at Oxford University&#xD;
             Hospitals Foundation Trust (unless directly related to ventilation or ablation&#xD;
             strategy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age&lt;18 and &gt;85&#xD;
&#xD;
          -  Left ventricular ejection fraction &lt;35%&#xD;
&#xD;
          -  Severe lung disease - chronic obstructive pulmonary disease or asthma requiring home&#xD;
             oxygen therapy or &gt;3 admissions in preceding 12 months&#xD;
&#xD;
          -  Previously failed high frequency jet ventilation due to hypercapnia&#xD;
&#xD;
          -  Previous catheter ablation for atrial fibrillation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yaver Bashir, MA,DM,FRCP</last_name>
    <role>Study Chair</role>
    <affiliation>Clinical Director, Consultant Electrophysiologist</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>John Radcliffe Hospital</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>February 1, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>May 27, 2021</last_update_submitted>
  <last_update_submitted_qc>May 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>atrial fibrillation</keyword>
  <keyword>catheter ablation</keyword>
  <keyword>general anaesthesia</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/NCT02968147
org study id: PID11559
nct id: NCT02968147
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Atrial fibrillation (AF) is a cardiac condition that results in patients experiencing an
      irregular heart beat resulting in symptoms including palpitations and breathlessness. It is
      known that in most cases, AF is caused by abnormal electrical activity from the top of the
      left side of the heart (left atrium) which overrides the heart natural pacemaker in the right
      atrium. Treatment options include tablets which suppress this abnormal electrical activity,
      but in some patients these are not sufficient and a procedure is carried out where the areas
      of abnormal electrical activity are disconnected or 'ablated' to prevent AF from occurring.
      This treatment is well established and performed worldwide, often under general anaesthetic
      (GA). The heart and lungs sit close together in the chest, and when the lungs are inflated
      and deflated during the procedure, the heart also moves. This movement is then transmitted to
      the special wires or 'catheters' that are placed inside the heart to deliver the ablation
      treatment. Instability during the treatment can result in ineffective areas of ablation which
      may later contribute to reduced success of the procedure. Previous research has shown that by
      reducing the movement of the heart under anaesthesia using alternative techniques can improve
      catheter stability and improve procedural results. Once such technique is called high
      frequency jet ventilation (HFJV) which allows the lungs to filled with air using fast and
      shallow breaths resulting in normal blood oxygen levels with little movement in the heart.
      This technique has been shown to be safe and effective for this procedure but a direct
      comparison with conventional ventilation has not been done. The investigators wish to test
      this and determine if using HFJV improves outcomes during the procedure (i.e. can
      investigators do the treatment faster and more effectively) and if this translates to better
      outcomes long term.
Catheter ablation for the treatment of the symptoms of fibrillation is now a well-established
      technique. The technique is complex and commonly undertaken under general anaesthesia.
      Catheters are introduced into the circulation from the veins at the top of the leg and
      advanced to the right side of the heart. Using x-ray and ultrasound guidance, the catheters
      are passed to the left atrium by puncturing the muscle that divides left and right atria
      (septum). A model of the left atrium is created and this used to guide the movement of an
      ablation catheter across the tissue and create ablation lesions that lead to electrical
      isolation of target sites.

      Under general anaesthesia, the lungs are inflated and deflated via the ventilator circuit.
      The expansion of the lungs results in movement of the heart with each respiratory cycle. This
      leads to catheter instability as the tissue is moved towards and away from a catheter
      positioned in the left atrium. This movement is particularly marked at the back of the left
      atrium. This instability can lead to real time variation in the delivery of energy which can
      result in ineffective lesions. These will then translate acutely to incomplete isolation and
      the need for further ablation (thereby increasing procedure time) and later into reconnection
      of tissue which can result in repeated procedures being needed to achieve an effective
      outcome. Each procedure carries risk of minor and major complications therefore measures to
      improve first time success are critical.

      Current research supports the use of steerable catheter sheaths (tubes through which the
      catheters travel to the atria) and 3 dimensional mapping in improving ablation parameters.
      Data also exists demonstrating significant variation in catheter contact despite these
      measures. In order to improve catheter stability further, changes to the mode of ventilation
      has been studied. Small studies have shown that by stopping cardiac movement altogether by
      transiently stopping ventilation (apnoea) catheter stability is improved and ablation is more
      effective. However, intermittent apnoea is not an effective method of ventilation in long
      cases. An alternative is high frequency jet ventilation. This is where the lungs are
      ventilated with low volume, high speed and high pressure breaths. This technique is well
      established and has safety data in upper airway surgery and liver radiology procedures where
      movement of airways and diaphragm needs to be minimized. In view of this, this technique has
      been studied in AF ablation and has been shown to improve catheter stability and energy
      delivery with no increase in complications related to the mode of ventilation. However,
      existing studies have focused mainly in paroxysmal AF patients (where less ablation is
      needed) and conducted in a non randomized trial design.

      The investigators wish to research the use of HFJV in patients undergoing ablation for
      persistent AF in a prospective and randomised trial to answer the primary and secondary
      questions shown below.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with improved catheter contact force during AF ablation under high frequency jet ventilation
time frame: 12 months
description: Data will be extracted from the St Jude Medical Velocity/Tacticath system to determine average force (grams/sec) for each applied lesion.
measure: Number of patients with improved lesion power delivery during AF ablation under high frequency jet ventilation
time frame: 12 months
description: Data will be extracted from the St Jude Medical Velocity/Tacticath system to determine power delivery (force time integral) for each applied lesion.
measure: Number of patients with improved lesion creation during AF ablation under high frequency jet ventilation
time frame: 12 months
description: Data will be extracted from the St Jude Medical Velocity/Tacticath system to determine power delivery (lesion size index) for each applied lesion.
measure: Number of patients with improved catheter stability during AF ablation under high frequency jet ventilation
time frame: 12 months
description: Data will be extracted from the St Jude Medical Velocity/Tacticath system to determine catheter movement (mm movement during ablation) for each applied lesion.
arm group label: Conventional ventilation
arm group type: Experimental
description: Catheter ablation for persistent atrial fibrillation with general anesthesia and conventional ventilation
arm group label: Jet ventilation
arm group type: Experimental
description: Catheter ablation for persistent atrial fibrillation with general anesthesia and high frequency jet ventilation
intervention type: Device
intervention name: High frequency jet ventilation
description: General anaesthesia and ventilation with the Acutronic Monsoon III Jet ventilator system
arm group label: Jet ventilation
intervention type: Device
intervention name: Conventional ventilation
description: General anaesthesia and ventilation with a conventional Phillips intermittent positive pressure ventilator system
arm group label: Conventional ventilation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Yaver Bashir, MA,DM,FRCP
role: Study Chair
affiliation: Clinical Director, Consultant Electrophysiologist
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No