<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/NCT03812601</url>
  </required_header>
  <id_info>
    <org_study_id>13608</org_study_id>
    <nct_id>NCT03812601</nct_id>
  </id_info>
  <brief_title>Biatrial Global High-density Electroanatomical Mapping of Atrial Fibrillation</brief_title>
  <acronym>BiMap-AF</acronym>
  <official_title>Biatrial Global High-density Electroanatomical Mapping of Atrial Fibrillation - a Prospective Mechanistic Study</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>
      This study uses two AcQMap imaging and electroanatomical mapping systems (Acutus Medical) to&#xD;
      simultaneously visualise and map patterns of wavefront propagation in both the left and right&#xD;
      atria during atrial fibrillation in order to identify mechanisms of rhythm propagation and&#xD;
      maintenance and the importance of the interaction of the left and right atria. Mapping will&#xD;
      also be performed during pacing from different sites and cycle lengths to identify regions of&#xD;
      abnormal conduction that may be related to the maintenance of atrial fibrillation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients undergoing first time catheter ablation for atrial fibrillation with undergo&#xD;
      simultaneous bi-atrial mapping using two linked AcQMap imaging and mapping systems from&#xD;
      Acutus Medical. Mapping will be performed during AF, sinus rhythm and pacing (following&#xD;
      cardioversion if required). Pacing will be undertaken from 3 sites in order to create&#xD;
      different vectors of conduction and at varying cycle lengths and coupling intervals in order&#xD;
      to identify regions of slow and anisotropic conduction. Patients will then undergo pulmonary&#xD;
      vein isolation by radiofrequency ablation followed by ablation of non-pulmonary vein targets&#xD;
      at the operators discretion (ablation in line with clinical practice and not as part of the&#xD;
      study). Regions of focal firing, rotational or slow conduction during AF will be noted and&#xD;
      the interaction between each atria described.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 11, 2018</start_date>
  <completion_date type="Actual">November 10, 2021</completion_date>
  <primary_completion_date type="Actual">September 10, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Spatiotemporal distribution of non-pulmonary vein focal impulses identified during non-contact mapping of atrial fibrillation</measure>
    <time_frame>Catheter ablation procedure</time_frame>
    <description>The number and location of focal impulses will be collected over 2 recordings</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Spatiotemporal distribution of irregular and rotational activation during 2 recordings of atrial fibrillation</measure>
    <time_frame>Catheter ablation procedure</time_frame>
    <description>Number of sites of irregular and rotational activation (LA and RA) and their frequency over time during 2 recordings of atrial fibrillation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of inter-atrial wavefront propagation during AF</measure>
    <time_frame>Catheter ablation procedure</time_frame>
    <description>Proportion of wavefronts originating in each atria activating from left to right and right to left and site of inter-atrial conduction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Outcome of AcQMap guided catheter ablation of atrial fibrillation</measure>
    <time_frame>12 months</time_frame>
    <description>Freedom from recurrent atrial fibrillation on 12 lead ECG or &gt;30seconds on ambulatory monitoring</description>
  </secondary_outcome>
  <enrollment type="Actual">22</enrollment>
  <condition>Atrial Fibrillation</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Simultaneous bi-atrial electroanatomic mapping and ablation</intervention_name>
    <description>Simultaneous bi-atrial electroanatomic mapping during atrial fibrillation and during pacing from 3 different vectors at varying cycle lengths followed by pulmonary vein isolation and AcQMap guided ablation of non-pulmonary vein mechanisms.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing their first catheter ablation procedure for atrial fibrillation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is willing and able to give informed consent for participation in the&#xD;
             trial.&#xD;
&#xD;
          -  Male or Female, aged 18 years or above.&#xD;
&#xD;
          -  Diagnosed with paroxysmal or persistent atrial fibrillation and planned for a catheter&#xD;
             ablation procedure.&#xD;
&#xD;
          -  In the Investigator's opinion is able and willing to comply with all trial&#xD;
             requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Physical or anatomical barriers to the use of two simultaneous mapping catheters&#xD;
&#xD;
          -  Previous cardiac surgery&#xD;
&#xD;
          -  Previous ablation (catheter or surgical)&#xD;
&#xD;
          -  Female participant who is pregnant, lactating or planning pregnancy during the course&#xD;
             of the trial.&#xD;
&#xD;
          -  Any other significant disease or disorder which, in the opinion of the Investigator,&#xD;
             may either put the participants at risk because of participation in the trial, or may&#xD;
             influence the result of the trial, or the participant's ability to participate in the&#xD;
             trial.&#xD;
&#xD;
          -  Participants who have participated in another research trial involving an&#xD;
             investigational medicinal product in the past 12 weeks. (Involvement in any other&#xD;
             research trial is not a contraindication per se.)&#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>Timothy R Betts, MB ChB, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oxford University Hospitals NHS Trust</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>January 2022</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 17, 2022</last_update_submitted>
  <last_update_submitted_qc>January 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oxford University Hospitals NHS Trust</investigator_affiliation>
    <investigator_full_name>Tim Betts MD MBChB FRCP</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <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/NCT03812601
org study id: 13608
nct id: NCT03812601
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study uses two AcQMap imaging and electroanatomical mapping systems (Acutus Medical) to
      simultaneously visualise and map patterns of wavefront propagation in both the left and right
      atria during atrial fibrillation in order to identify mechanisms of rhythm propagation and
      maintenance and the importance of the interaction of the left and right atria. Mapping will
      also be performed during pacing from different sites and cycle lengths to identify regions of
      abnormal conduction that may be related to the maintenance of atrial fibrillation.
Patients undergoing first time catheter ablation for atrial fibrillation with undergo
      simultaneous bi-atrial mapping using two linked AcQMap imaging and mapping systems from
      Acutus Medical. Mapping will be performed during AF, sinus rhythm and pacing (following
      cardioversion if required). Pacing will be undertaken from 3 sites in order to create
      different vectors of conduction and at varying cycle lengths and coupling intervals in order
      to identify regions of slow and anisotropic conduction. Patients will then undergo pulmonary
      vein isolation by radiofrequency ablation followed by ablation of non-pulmonary vein targets
      at the operators discretion (ablation in line with clinical practice and not as part of the
      study). Regions of focal firing, rotational or slow conduction during AF will be noted and
      the interaction between each atria described.
observational model: Cohort
time perspective: Prospective
measure: Spatiotemporal distribution of non-pulmonary vein focal impulses identified during non-contact mapping of atrial fibrillation
time frame: Catheter ablation procedure
description: The number and location of focal impulses will be collected over 2 recordings
measure: Spatiotemporal distribution of irregular and rotational activation during 2 recordings of atrial fibrillation
time frame: Catheter ablation procedure
description: Number of sites of irregular and rotational activation (LA and RA) and their frequency over time during 2 recordings of atrial fibrillation
measure: Frequency of inter-atrial wavefront propagation during AF
time frame: Catheter ablation procedure
description: Proportion of wavefronts originating in each atria activating from left to right and right to left and site of inter-atrial conduction
measure: Outcome of AcQMap guided catheter ablation of atrial fibrillation
time frame: 12 months
description: Freedom from recurrent atrial fibrillation on 12 lead ECG or >30seconds on ambulatory monitoring
intervention type: Procedure
intervention name: Simultaneous bi-atrial electroanatomic mapping and ablation
description: Simultaneous bi-atrial electroanatomic mapping during atrial fibrillation and during pacing from 3 different vectors at varying cycle lengths followed by pulmonary vein isolation and AcQMap guided ablation of non-pulmonary vein mechanisms.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Timothy R Betts, MB ChB, MD
role: Principal Investigator
affiliation: Oxford University Hospitals NHS Trust
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Oxford University Hospitals NHS Trust
investigator full name: Tim Betts MD MBChB FRCP
investigator title: Principle Investigator
mesh term: Atrial Fibrillation
sharing ipd: No