<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/NCT03750435</url>
  </required_header>
  <id_info>
    <org_study_id>BMRBH01</org_study_id>
    <nct_id>NCT03750435</nct_id>
  </id_info>
  <brief_title>Non-fluoroscopy Ablation of AF/AT</brief_title>
  <acronym>ZERO-AF</acronym>
  <official_title>ZERO Radiation Exposure for Catheter Ablation of Atrial Fibrillation or Left Atrial Tachycardia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Brompton &amp; Harefield NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baylis Medical Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal Brompton &amp; Harefield NHS Foundation 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 is the most common arrhythmia but can be treated by a catheter procedure&#xD;
      where specialized wires (so-called catheters) are inserted in the left upper heart chamber.&#xD;
      This requires crossing the wall between the right and left atrium with a long needle (a&#xD;
      so-called transseptal puncture or TSP). This is typically done using x-ray guidance or echo&#xD;
      to check if the needle is in the right position. The investigators developed a method to do&#xD;
      the TSP without x-rays using a specialized needle that can be also shown as a little icon on&#xD;
      the 3D electroanatomical mapping system (CARTO).3D mapping systems are routinely used to&#xD;
      track the location of the catheters in cath labs worldwide, but the position of the needle&#xD;
      was not tracked yet. The investigators seek to demonstrate that these procedures can be&#xD;
      carried out safely, successfully and in a reproducible fashion without any radiation by&#xD;
      taking advantage of &quot;faking&quot; the isolated tip of the needle as a catheter on the 3D mapping&#xD;
      system. The results will be compared with historic procedures done by the same operator in&#xD;
      the years 2012-2017.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The hypothesis is that patients who undergo one or more TSP(s) for atrial fibrillation or&#xD;
      left atrial tachycardia can be studied without the use of fluoroscopy which should result in&#xD;
      a low or ZERO overall radiation exposure for the entire ablation procedure. The investigators&#xD;
      will assess the feasibility, safety and efficacy of this new approach.&#xD;
&#xD;
      The patient will be admitted in hospital as for a standard procedure and discharged the next&#xD;
      day. Before admission, the patient undergoes a CMR/CT scan (routine in our centre). To avoid&#xD;
      total radiation CMR would be preferred, if possible.&#xD;
&#xD;
      The technique of the TSP and the use of the RF needle is commonly used worldwide. The ability&#xD;
      to visualize the needle tip on the 3D electroanatomical mapping system facilitates the&#xD;
      procedure. The additional visualization by TOE helps to assure that the fossa ovalis has been&#xD;
      correctly identified.&#xD;
&#xD;
      After the TSP, the ablation procedure itself will be carried out as conventionally performed&#xD;
      using the catheter visualization on the 3D mapping system.&#xD;
&#xD;
      An ECG and an echocardiogram are performed before discharge (as standard care).&#xD;
&#xD;
      At 3 months the patient comes for the first visit and has an ECG, a Holter and symptom&#xD;
      questionnaire.&#xD;
&#xD;
      At 6 months, the patient has second visit which includes an ECG, a symptom questionnaire, a&#xD;
      Holter and an echocardiogram.&#xD;
&#xD;
      If recurrences of any arrhythmia occur, the patient can be scheduled for a second ablation&#xD;
      procedure without any restrictions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 8, 2018</start_date>
  <completion_date type="Anticipated">October 8, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2019</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>
    <intervention_model_description>prospective single arm</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety of the zero AF procedure</measure>
    <time_frame>6 months</time_frame>
    <description>Absence of acute adverse events due to the use of non-fluoroscopic AF ablation&#xD;
• Evidence of chronic adverse events due to the use of non-fluoroscopic catheter ablation during the 6 months F/U period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility and efficacy</measure>
    <time_frame>6 months</time_frame>
    <description>Assessment on efficacy of non-fluoroscopic AF acutely and if recurrences in 6 months follow up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrences</measure>
    <time_frame>6 months</time_frame>
    <description>Time to first recurrence of AF/flutter/tachycardia (&gt;30 sec)&#xD;
Freedom of AF on previously failed antiarrhythmic medication; time-dependant variable&#xD;
AF/flutter/tachycardia (&gt; 30 sec) burden at 6 months F/U; this will be modelled as a continuous variable (number of episodes recorded)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>AF - Atrial Fibrillation</condition>
  <condition>Atrial Tachycardia</condition>
  <arm_group>
    <arm_group_label>Ablation for AF or left-sided AT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient will be admitted in hospital as for a standard ablation procedure and discharged the next day. The procedure will be carried out without using fluoroscopy and relying on the visualization of the electroanatomical mapping system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>AF ablation or left-sided AT ablation</intervention_name>
    <description>According to the type of AF/AT, single or double transseptal and subsequent catheter ablation in the left atrium using radiofrequency will be performed.</description>
    <arm_group_label>Ablation for AF or left-sided AT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any type of atrial fibrillation or left atrial tachycardia&#xD;
&#xD;
               -  Able to give written informed consent&#xD;
&#xD;
               -  Age &gt;18 years old and ≤ 80 years&#xD;
&#xD;
               -  Fulfill established clinical criteria for catheter ablation of atrial&#xD;
                  fibrillation (1)&#xD;
&#xD;
               -  No evidence of significant structural heart disease or congenital heart disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Intolerance or unwillingness to oral anticoagulation with Warfarin&#xD;
&#xD;
          -  Bleeding disorder&#xD;
&#xD;
          -  Contraindication to CT scan&#xD;
&#xD;
          -  Presence of intracardiac thrombus&#xD;
&#xD;
          -  Vascular disorder preventing access to femoral veins&#xD;
&#xD;
          -  Cardiac congenital abnormality&#xD;
&#xD;
          -  Severe, life threatening non-cardiac disease&#xD;
&#xD;
          -  Active malignant disease and recent (&lt;5 years) malignant disease&#xD;
&#xD;
          -  Presence of ASD or PFO closure device&#xD;
&#xD;
          -  Unable or unwilling to comply with F/U requirements&#xD;
&#xD;
          -  Renal impairment&#xD;
&#xD;
          -  Pregnancy&#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_official>
    <last_name>Sabine Ernst, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Brompton and Harefield NHS</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sabine Ernst, MD</last_name>
    <role>Study Director</role>
    <affiliation>Royal Brompton and Harefield NHS</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sabine Ernst, MD</last_name>
    <phone>02073518612</phone>
    <email>s.ernst@rbht.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jenny Rivers</last_name>
    <phone>020 7352 8121</phone>
    <email>j.rivers@rbht.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Royal Brompton and Harefield NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SW3 6NP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jenny Rivers</last_name>
      <phone>020 7352 8121</phone>
      <email>j.rivers@rbht.nhs.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Tachycardia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Any data of this trial will be shared only in an anonymised fashion and as part of scientific publications</ipd_description>
  </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/NCT03750435
org study id: BMRBH01
nct id: NCT03750435
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Atrial fibrillation is the most common arrhythmia but can be treated by a catheter procedure
      where specialized wires (so-called catheters) are inserted in the left upper heart chamber.
      This requires crossing the wall between the right and left atrium with a long needle (a
      so-called transseptal puncture or TSP). This is typically done using x-ray guidance or echo
      to check if the needle is in the right position. The investigators developed a method to do
      the TSP without x-rays using a specialized needle that can be also shown as a little icon on
      the 3D electroanatomical mapping system (CARTO).3D mapping systems are routinely used to
      track the location of the catheters in cath labs worldwide, but the position of the needle
      was not tracked yet. The investigators seek to demonstrate that these procedures can be
      carried out safely, successfully and in a reproducible fashion without any radiation by
      taking advantage of "faking" the isolated tip of the needle as a catheter on the 3D mapping
      system. The results will be compared with historic procedures done by the same operator in
      the years 2012-2017.
The hypothesis is that patients who undergo one or more TSP(s) for atrial fibrillation or
      left atrial tachycardia can be studied without the use of fluoroscopy which should result in
      a low or ZERO overall radiation exposure for the entire ablation procedure. The investigators
      will assess the feasibility, safety and efficacy of this new approach.

      The patient will be admitted in hospital as for a standard procedure and discharged the next
      day. Before admission, the patient undergoes a CMR/CT scan (routine in our centre). To avoid
      total radiation CMR would be preferred, if possible.

      The technique of the TSP and the use of the RF needle is commonly used worldwide. The ability
      to visualize the needle tip on the 3D electroanatomical mapping system facilitates the
      procedure. The additional visualization by TOE helps to assure that the fossa ovalis has been
      correctly identified.

      After the TSP, the ablation procedure itself will be carried out as conventionally performed
      using the catheter visualization on the 3D mapping system.

      An ECG and an echocardiogram are performed before discharge (as standard care).

      At 3 months the patient comes for the first visit and has an ECG, a Holter and symptom
      questionnaire.

      At 6 months, the patient has second visit which includes an ECG, a symptom questionnaire, a
      Holter and an echocardiogram.

      If recurrences of any arrhythmia occur, the patient can be scheduled for a second ablation
      procedure without any restrictions.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: prospective single arm
primary purpose: Treatment
masking: None (Open Label)
measure: Safety of the zero AF procedure
time frame: 6 months
description: Absence of acute adverse events due to the use of non-fluoroscopic AF ablation
• Evidence of chronic adverse events due to the use of non-fluoroscopic catheter ablation during the 6 months F/U period
measure: Feasibility and efficacy
time frame: 6 months
description: Assessment on efficacy of non-fluoroscopic AF acutely and if recurrences in 6 months follow up
measure: Recurrences
time frame: 6 months
description: Time to first recurrence of AF/flutter/tachycardia (>30 sec)
Freedom of AF on previously failed antiarrhythmic medication; time-dependant variable
AF/flutter/tachycardia (> 30 sec) burden at 6 months F/U; this will be modelled as a continuous variable (number of episodes recorded)
arm group label: Ablation for AF or left-sided AT
arm group type: Experimental
description: The patient will be admitted in hospital as for a standard ablation procedure and discharged the next day. The procedure will be carried out without using fluoroscopy and relying on the visualization of the electroanatomical mapping system.
intervention type: Procedure
intervention name: AF ablation or left-sided AT ablation
description: According to the type of AF/AT, single or double transseptal and subsequent catheter ablation in the left atrium using radiofrequency will be performed.
arm group label: Ablation for AF or left-sided AT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Sabine Ernst, MD
role: Principal Investigator
affiliation: Royal Brompton and Harefield NHS
last name: Sabine Ernst, MD
role: Study Director
affiliation: Royal Brompton and Harefield NHS
last name: Sabine Ernst, MD
phone: 02073518612
email: s.ernst@rbht.nhs.uk
last name: Jenny Rivers
phone: 020 7352 8121
email: j.rivers@rbht.nhs.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Tachycardia
sharing ipd: Yes
ipd description: Any data of this trial will be shared only in an anonymised fashion and as part of scientific publications