xml: <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/NCT05988424</url>
    </required_header>
    <id_info>
      <org_study_id>RHM CAR0638</org_study_id>
      <nct_id>NCT05988424</nct_id>
    </id_info>
    <brief_title>Randomised Comparison of the Octaray and Pentaray Catheters</brief_title>
    <acronym>COPEC</acronym>
    <official_title>Randomised Comparison of the Octaray and Pentaray Catheters</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital Southampton NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Biosense Webster, Inc.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospital Southampton NHS Foundation Trust</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>
        In this study we aim to compare the mapping performance in the left atrium of the established&#xD;
        Pentaray catheter to the newer Octaray catheter.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Compared with conventional point by point mapping, the use of a multipolar high density&#xD;
        Pentaray catheter (Biosense Webster, Diamond Bar, CA, USA) has been found to produce more&#xD;
        rapid, accurate maps. This catheter has 20, 2mm2 electrodes. Newer, high density mapping&#xD;
        catheters have also been introduced, capable of collecting detailed maps rapidly. Such&#xD;
        catheters include the Orion catheter (Boston Scientific, Marlborough, MA, USA) which has 64,&#xD;
        0.4mm2 electrodes and has been shown to be safe and effective in real world usage, and the HD&#xD;
        Grid (Abbott Cardiovascular, Lake Forest, IL, USA) which has 16, 1mm electrodes and has been&#xD;
        shown to be associated with shorter procedure and fluoroscopy times and better success rates&#xD;
        than conventional circular mapping catheters when used for AF ablation.&#xD;
  &#xD;
        Of the above high density catheters, the Pentaray is integrated into the Carto3 system. An&#xD;
        advantage of this platform for mapping is the ability to use the Tissue Proximity Indicator&#xD;
        (TPI) Filter to reduce the number of points collected without contact and improve the&#xD;
        accuracy of the subsequent voltage map.&#xD;
  &#xD;
        A novel multipolar catheter, iterating on the previous Pentaray catheter is now being&#xD;
        introduced: Octaray. This has 48, 0.9mm2 electrodes arranged on 8 splines. In preclinical&#xD;
        studies, Octaray has been found to be collect maps faster, at higher density and with greater&#xD;
        accuracy for conduction gaps than the Pentaray. The new catheter has been used safely in&#xD;
        clinical cases.&#xD;
  &#xD;
        Methods This is a randomised, prospective, single centre, interventional study, Thirty&#xD;
        patients listed for redo AF ablation procedures on clinical grounds will be included in the&#xD;
        study. Procedures will be under conscious sedation or general anaesthetic as per the&#xD;
        preference of the operator, as will the mode of transeptal access and sheaths used to deliver&#xD;
        the mapping catheter to the left atrium.&#xD;
  &#xD;
        At the start of the case, two consecutive LA maps will be taken by the same operator using&#xD;
        the Pentaray and Octaray catheters. In both cases, throughout the study the same catheter&#xD;
        types will be used. For the Pentaray catheter, this will be the standard 4-4-4 spaced&#xD;
        version. The Octaray for the study will be the larger, 20mm spline version, with the&#xD;
        3-3-3-3-3 spacing.&#xD;
  &#xD;
        To minimise any learning effect from repeated map collections in the same chamber, patients&#xD;
        will be randomly assigned, using block randomisation, as to whether their first LA map will&#xD;
        be collected using the Octaray or Pentaray. The randomised group the patient is in will be&#xD;
        kept in a sealed envelope which will only be opened on the day of the procedure. All maps&#xD;
        will be respiratory gated. The same sheath will be used for both catheters. For the study&#xD;
        protocol, maps will be taken with first one mapping catheter and then the alternative. The&#xD;
        rhythm during collection will be the same for both maps. Ideally patients would be in sinus&#xD;
        rhythm, with maps collected with coronary sinus pacing. If there were challenges maintaining&#xD;
        sinus rhythm during mapping, maps can be taken in AF (though not a mixture of rhythms). The&#xD;
        setup in terms of window of interest and references will also be identical. The map detail&#xD;
        level will be left at 16 for all maps. The map maximum point density will be left as nominal.&#xD;
        The fill and colour thresholds will be kept unchanged at nominal values. No ablation will be&#xD;
        permitted between the two maps being collected. When the second map is being collected using&#xD;
        the alternative catheter, this will be a new map and not a remap and the prior map will be&#xD;
        hidden from the operator.&#xD;
  &#xD;
        In order to control for any matrix collected by the initial catheter in taking the first map,&#xD;
        a completely new study will be used for the second map.&#xD;
  &#xD;
        TPI will be on for the entire collection period for both maps. The time when map collection&#xD;
        was started, as well as the fluoroscopy time at that point will be noted. These values will&#xD;
        also be noted at the end of the map collection. The aim of map collection will be to get&#xD;
        entire coverage of the geometry with voltage data. Where this was not possible will be noted.&#xD;
        The time for the catheter to start collecting voltage data will also be recorded, to judge&#xD;
        the delay in TPI filter accepted points for the two catheters.&#xD;
  &#xD;
        LA Map volumes will be collected from Carto3. The pulmonary veins and any left ventricle&#xD;
        inadvertently collected will be removed from the geometries to allow quantitative assessment.&#xD;
  &#xD;
        Once the mapping phase has been completed, the operator would complete the procedure as to&#xD;
        their usual practice.&#xD;
  &#xD;
        There will be no follow up needed for the study. Any acute complications will be noted -&#xD;
        acute in this case being defined as complications occurring up to 30 days post-procedure.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>Crossover Assignment</intervention_model>
      <intervention_model_description>Crossover from one mapping catheter to the other with randomisation as to which catheter is used first</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>The patient will not be aware which mapping catheter they are randomised to have used in their case first.&#xD;
  The data will be processed for analysis blinded to the catheter used to collect the map</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Time to collect left atrial geometry</measure>
      <time_frame>1 year</time_frame>
      <description>Time to collect left atrial geometry</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Volume of LA geometry</measure>
      <time_frame>1 year</time_frame>
      <description>Volume of LA geometry</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Map point density</measure>
      <time_frame>1 year</time_frame>
      <description>Map point density</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to start point collection, based on fulfilment of TPI criteria</measure>
      <time_frame>1 year</time_frame>
      <description>Time to start point collection, based on fulfilment of TPI criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Low voltage area comparison</measure>
      <time_frame>1 year</time_frame>
      <description>Low voltage area comparison</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number and size of PVI gaps identified</measure>
      <time_frame>1 year</time_frame>
      <description>Number and size of PVI gaps identified</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Atrial Fibrillation</condition>
    <arm_group>
      <arm_group_label>Pentaray</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Initial map collected with Pentaray</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Octaray</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Initial map collected with Octaray</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Left atrial mapping</intervention_name>
      <description>Creation of a left atrial voltage map</description>
      <arm_group_label>Octaray</arm_group_label>
      <arm_group_label>Pentaray</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients &gt;18 years listed for redo AF ablation on clinical grounds GA or LA/sedation cases&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Age &lt;18 years Pregnancy Unable or unwilling to consent Mechanical mitral valve Replacement&#xD;
          Enrolled in another clinical study that could confound the results of this study (note:&#xD;
          patients enrolled in complementary study are eligible for enrolment)&#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>Waqas Ullah</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital Southampton NHS Foundation Trust</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Waqas Ullah</last_name>
      <phone>+442381208128</phone>
      <email>waqas.ullah@uhs.nhs.uk</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>atrial fibrillation</keyword>
    <keyword>ablation</keyword>
    <keyword>mapping</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>
      <ipd_description>Only anonymised data will be shared</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05988424
  org study id: RHM CAR0638
  nct id: NCT05988424
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  In this study we aim to compare the mapping performance in the left atrium of the established
        Pentaray catheter to the newer Octaray catheter.
  Compared with conventional point by point mapping, the use of a multipolar high density
        Pentaray catheter (Biosense Webster, Diamond Bar, CA, USA) has been found to produce more
        rapid, accurate maps. This catheter has 20, 2mm2 electrodes. Newer, high density mapping
        catheters have also been introduced, capable of collecting detailed maps rapidly. Such
        catheters include the Orion catheter (Boston Scientific, Marlborough, MA, USA) which has 64,
        0.4mm2 electrodes and has been shown to be safe and effective in real world usage, and the HD
        Grid (Abbott Cardiovascular, Lake Forest, IL, USA) which has 16, 1mm electrodes and has been
        shown to be associated with shorter procedure and fluoroscopy times and better success rates
        than conventional circular mapping catheters when used for AF ablation.
  
        Of the above high density catheters, the Pentaray is integrated into the Carto3 system. An
        advantage of this platform for mapping is the ability to use the Tissue Proximity Indicator
        (TPI) Filter to reduce the number of points collected without contact and improve the
        accuracy of the subsequent voltage map.
  
        A novel multipolar catheter, iterating on the previous Pentaray catheter is now being
        introduced: Octaray. This has 48, 0.9mm2 electrodes arranged on 8 splines. In preclinical
        studies, Octaray has been found to be collect maps faster, at higher density and with greater
        accuracy for conduction gaps than the Pentaray. The new catheter has been used safely in
        clinical cases.
  
        Methods This is a randomised, prospective, single centre, interventional study, Thirty
        patients listed for redo AF ablation procedures on clinical grounds will be included in the
        study. Procedures will be under conscious sedation or general anaesthetic as per the
        preference of the operator, as will the mode of transeptal access and sheaths used to deliver
        the mapping catheter to the left atrium.
  
        At the start of the case, two consecutive LA maps will be taken by the same operator using
        the Pentaray and Octaray catheters. In both cases, throughout the study the same catheter
        types will be used. For the Pentaray catheter, this will be the standard 4-4-4 spaced
        version. The Octaray for the study will be the larger, 20mm spline version, with the
        3-3-3-3-3 spacing.
  
        To minimise any learning effect from repeated map collections in the same chamber, patients
        will be randomly assigned, using block randomisation, as to whether their first LA map will
        be collected using the Octaray or Pentaray. The randomised group the patient is in will be
        kept in a sealed envelope which will only be opened on the day of the procedure. All maps
        will be respiratory gated. The same sheath will be used for both catheters. For the study
        protocol, maps will be taken with first one mapping catheter and then the alternative. The
        rhythm during collection will be the same for both maps. Ideally patients would be in sinus
        rhythm, with maps collected with coronary sinus pacing. If there were challenges maintaining
        sinus rhythm during mapping, maps can be taken in AF (though not a mixture of rhythms). The
        setup in terms of window of interest and references will also be identical. The map detail
        level will be left at 16 for all maps. The map maximum point density will be left as nominal.
        The fill and colour thresholds will be kept unchanged at nominal values. No ablation will be
        permitted between the two maps being collected. When the second map is being collected using
        the alternative catheter, this will be a new map and not a remap and the prior map will be
        hidden from the operator.
  
        In order to control for any matrix collected by the initial catheter in taking the first map,
        a completely new study will be used for the second map.
  
        TPI will be on for the entire collection period for both maps. The time when map collection
        was started, as well as the fluoroscopy time at that point will be noted. These values will
        also be noted at the end of the map collection. The aim of map collection will be to get
        entire coverage of the geometry with voltage data. Where this was not possible will be noted.
        The time for the catheter to start collecting voltage data will also be recorded, to judge
        the delay in TPI filter accepted points for the two catheters.
  
        LA Map volumes will be collected from Carto3. The pulmonary veins and any left ventricle
        inadvertently collected will be removed from the geometries to allow quantitative assessment.
  
        Once the mapping phase has been completed, the operator would complete the procedure as to
        their usual practice.
  
        There will be no follow up needed for the study. Any acute complications will be noted -
        acute in this case being defined as complications occurring up to 30 days post-procedure.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Crossover from one mapping catheter to the other with randomisation as to which catheter is used first
  primary purpose: Other
  masking: Double (Participant, Outcomes Assessor)
  masking description: The patient will not be aware which mapping catheter they are randomised to have used in their case first.
  The data will be processed for analysis blinded to the catheter used to collect the map
  measure: Time to collect left atrial geometry
  time frame: 1 year
  description: Time to collect left atrial geometry
  measure: Volume of LA geometry
  time frame: 1 year
  description: Volume of LA geometry
  measure: Map point density
  time frame: 1 year
  description: Map point density
  measure: Time to start point collection, based on fulfilment of TPI criteria
  time frame: 1 year
  description: Time to start point collection, based on fulfilment of TPI criteria
  measure: Low voltage area comparison
  time frame: 1 year
  description: Low voltage area comparison
  measure: Number and size of PVI gaps identified
  time frame: 1 year
  description: Number and size of PVI gaps identified
  arm group label: Pentaray
  arm group type: Active Comparator
  description: Initial map collected with Pentaray
  arm group label: Octaray
  arm group type: Active Comparator
  description: Initial map collected with Octaray
  intervention type: Other
  intervention name: Left atrial mapping
  description: Creation of a left atrial voltage map
  arm group label: Octaray
  arm group label: Pentaray
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Waqas Ullah
  role: Principal Investigator
  affiliation: University Hospital Southampton NHS Foundation Trust
  last name: Waqas Ullah
  phone: +442381208128
  email: waqas.ullah@uhs.nhs.uk
  responsible party type: Sponsor
  mesh term: Atrial Fibrillation
  sharing ipd: No
  ipd description: Only anonymised data will be shared