<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/NCT03811938</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS 202816</org_study_id>
    <nct_id>NCT03811938</nct_id>
  </id_info>
  <brief_title>Ablation of Low Voltage Regions in Persistent Atrial Fibrillation</brief_title>
  <acronym>ABLOVO-AF</acronym>
  <official_title>Catheter ABlation of Low Voltage Regions in the Treatment of Persistent Atrial Fibrillation (ABLOVO-AF Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Imperial College London</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>
      Background. Atrial fibrillation (AF) is a disorganised rhythm of the upper chambers of the&#xD;
      heart. It can lead to severe complications including stroke or heart failure. It can be&#xD;
      treated with radiofrequency ablation (RFA). This technology works by heating heart muscle&#xD;
      inside the heart to break the electrical circuits responsible for the abnormal rhythm.&#xD;
&#xD;
      The energy is delivered into the heart with plastic tubes that have metal electrodes,&#xD;
      inserted through the groin veins and removed after the procedure. The patient is usually put&#xD;
      to sleep during the intervention.&#xD;
&#xD;
      If the AF has been present for more than seven days but for less than one year it is called&#xD;
      persistent, and it can be difficult to treat successfully with the usual methods.&#xD;
&#xD;
      Goals. The study will test a new RFA technique to treat patients with persistent AF. This&#xD;
      involves identifying areas within the left upper chamber that have a lower electrical voltage&#xD;
      than the surrounding heart muscle and applying RFA to the border zones of these areas.&#xD;
&#xD;
      Methods. The new technology combined with the usual procedure will be compared to the usual&#xD;
      procedure alone. All patients will receive ablation according to the new technique and&#xD;
      results will be compared to a historical control group from the trial institution.&#xD;
&#xD;
      Follow up. Patients will be followed up for 12 months with clinic visits and heart rhythm&#xD;
      checks.&#xD;
&#xD;
      Potential benefit. The new technique will be assessed for success at keeping patients free&#xD;
      from persistent AF compared to the usual methods.&#xD;
&#xD;
      The study will be performed at Imperial College Healthcare NHS Trust, at the Hammersmith&#xD;
      Hospital. Licensed clinical software will be used from St Jude Medical to guide ablation and&#xD;
      a special research software module will be used to analyse data from the heart following&#xD;
      ablation. The study will be sponsored by Imperial College Healthcare NHS Trust&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 24, 2017</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2020</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Atrial fibrillation recurrence</measure>
    <time_frame>3-12 months.</time_frame>
    <description>Recurrence of atrial arrhythmia of at least 30s in duration. Investigation period for arrhythmia recurrence will be between 3 and 12 months after the first procedure, allowing for a blanking period of 3 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Canadian Cardiovascular Society Severity in Atrial Fibrillation Score</measure>
    <time_frame>12 months</time_frame>
    <description>Canadian Cardiovascular Society Severity in Atrial Fibrillation (CCS-SAF) change.&#xD;
0 represents no symptoms, 4 represents symptoms that significantly interfere with quality of life and exercise capacity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antiarrhythmic drugs</measure>
    <time_frame>3-12 months</time_frame>
    <description>Change in the number of antiarrhythmic drugs per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of AF ablations</measure>
    <time_frame>3-12 months</time_frame>
    <description>Number of additional AF ablations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>3-12 months</time_frame>
    <description>Number and rate of complications in the study population.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Persistent Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Pulmonary Vein Isolation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Historical control from cases performed in year 2017 at Hammersmith Hospital. Intervention: Pulmonary vein isolation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low voltage ablation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active arm, Intervention: Standard pulmonary vein isolation and Low Voltage Ablation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Low voltage ablation</intervention_name>
    <description>Catheter ablation of low voltage areas in the left atrium and catheter ablation aiming for the electrical isolation of the pulmonary veins.</description>
    <arm_group_label>Low voltage ablation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pulmonary Vein Isolation</intervention_name>
    <description>Catheter ablation aiming for the electrical isolation of the pulmonary veins.</description>
    <arm_group_label>Pulmonary Vein Isolation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Suitable candidate for catheter mapping/ablation for arrhythmias.&#xD;
&#xD;
          2. Eighteen (18) to eighty-five (85) years of age&#xD;
&#xD;
          3. Body Mass Index (BMI) &lt; 40 (Wt. in Kgs / Ht. in m2)&#xD;
&#xD;
          4. Signed Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe cerebrovascular disease&#xD;
&#xD;
          2. Moderate to severe renal impairment (eGFR &lt; 30)&#xD;
&#xD;
          3. Active gastrointestinal bleeding&#xD;
&#xD;
          4. Active infection or fever&#xD;
&#xD;
          5. Short life expectancy&#xD;
&#xD;
          6. Significant anemia&#xD;
&#xD;
          7. Severe uncontrolled systemic hypertension&#xD;
&#xD;
          8. Severe electrolyte imbalance&#xD;
&#xD;
          9. Ejection fraction of &lt; 35%&#xD;
&#xD;
         10. Congestive heart failure (NYHA Class IV)&#xD;
&#xD;
         11. Unstable angina requiring emergent PTCA (percutaneous transluminal coronary&#xD;
             angioplasty) or CABG (coronary artery bypass graft)&#xD;
&#xD;
         12. Recent myocardial infarction&#xD;
&#xD;
         13. Bleeding or clotting disorders&#xD;
&#xD;
         14. Uncontrolled diabetes&#xD;
&#xD;
         15. Inability to receive IV or oral Anticoagulants&#xD;
&#xD;
         16. Unable to give informed consent (these patients would not be recruited)&#xD;
&#xD;
         17. Previous catheter or surgical ablation treatment for atrial fibrillation.&#xD;
&#xD;
         18. Paroxysmal atrial fibrillation.&#xD;
&#xD;
         19. Pregnancy (urinary pregnancy test will be offered on the day of the procedure for all&#xD;
             women of reproductive age)&#xD;
&#xD;
         20. Drug and/or alcohol abuse&#xD;
&#xD;
         21. Transient factors for AF&#xD;
&#xD;
         22. Severe LA enlargement of &gt;60 mm in diameter on echocardiography&#xD;
&#xD;
         23. Patients who have participated in another study of an investigational medicinal&#xD;
             product in the last 3 months.&#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>Phang B Lim, MB BChir</last_name>
    <role>Principal Investigator</role>
    <affiliation>Imperial College Healthcare NHS Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Szabolcs Nagy, MD</last_name>
    <phone>447821694566</phone>
    <email>s.nagy@nhs.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hammersmith Hospital</name>
      <address>
        <city>London</city>
        <zip>W12 0HS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Szabolcs Nagy, MD</last_name>
      <phone>447821694566</phone>
      <email>s.nagy@nhs.net</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Radiofrequency Catheter Ablation</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/NCT03811938
org study id: IRAS 202816
nct id: NCT03811938
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background. Atrial fibrillation (AF) is a disorganised rhythm of the upper chambers of the
      heart. It can lead to severe complications including stroke or heart failure. It can be
      treated with radiofrequency ablation (RFA). This technology works by heating heart muscle
      inside the heart to break the electrical circuits responsible for the abnormal rhythm.

      The energy is delivered into the heart with plastic tubes that have metal electrodes,
      inserted through the groin veins and removed after the procedure. The patient is usually put
      to sleep during the intervention.

      If the AF has been present for more than seven days but for less than one year it is called
      persistent, and it can be difficult to treat successfully with the usual methods.

      Goals. The study will test a new RFA technique to treat patients with persistent AF. This
      involves identifying areas within the left upper chamber that have a lower electrical voltage
      than the surrounding heart muscle and applying RFA to the border zones of these areas.

      Methods. The new technology combined with the usual procedure will be compared to the usual
      procedure alone. All patients will receive ablation according to the new technique and
      results will be compared to a historical control group from the trial institution.

      Follow up. Patients will be followed up for 12 months with clinic visits and heart rhythm
      checks.

      Potential benefit. The new technique will be assessed for success at keeping patients free
      from persistent AF compared to the usual methods.

      The study will be performed at Imperial College Healthcare NHS Trust, at the Hammersmith
      Hospital. Licensed clinical software will be used from St Jude Medical to guide ablation and
      a special research software module will be used to analyse data from the heart following
      ablation. The study will be sponsored by Imperial College Healthcare NHS Trust
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Atrial fibrillation recurrence
time frame: 3-12 months.
description: Recurrence of atrial arrhythmia of at least 30s in duration. Investigation period for arrhythmia recurrence will be between 3 and 12 months after the first procedure, allowing for a blanking period of 3 months.
measure: Canadian Cardiovascular Society Severity in Atrial Fibrillation Score
time frame: 12 months
description: Canadian Cardiovascular Society Severity in Atrial Fibrillation (CCS-SAF) change.
0 represents no symptoms, 4 represents symptoms that significantly interfere with quality of life and exercise capacity.
measure: Antiarrhythmic drugs
time frame: 3-12 months
description: Change in the number of antiarrhythmic drugs per patient
measure: Number of AF ablations
time frame: 3-12 months
description: Number of additional AF ablations
measure: Complication rate
time frame: 3-12 months
description: Number and rate of complications in the study population.
arm group label: Pulmonary Vein Isolation
arm group type: Active Comparator
description: Historical control from cases performed in year 2017 at Hammersmith Hospital. Intervention: Pulmonary vein isolation.
arm group label: Low voltage ablation
arm group type: Experimental
description: Active arm, Intervention: Standard pulmonary vein isolation and Low Voltage Ablation.
intervention type: Procedure
intervention name: Low voltage ablation
description: Catheter ablation of low voltage areas in the left atrium and catheter ablation aiming for the electrical isolation of the pulmonary veins.
arm group label: Low voltage ablation
intervention type: Procedure
intervention name: Pulmonary Vein Isolation
description: Catheter ablation aiming for the electrical isolation of the pulmonary veins.
arm group label: Pulmonary Vein Isolation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Phang B Lim, MB BChir
role: Principal Investigator
affiliation: Imperial College Healthcare NHS Trust
last name: Szabolcs Nagy, MD
phone: 447821694566
email: s.nagy@nhs.net
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No