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/NCT06014814</url>
    </required_header>
    <id_info>
      <org_study_id>PFA-Sedation-Study</org_study_id>
      <secondary_id>IRAS</secondary_id>
      <nct_id>NCT06014814</nct_id>
    </id_info>
    <brief_title>Feasibility of Pulsed Field Ablation Under Mild Conscious Sedation</brief_title>
    <official_title>Pulsed Field Ablation Under Mild Conscious Sedation - A Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Liverpool Heart and Chest Hospital NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Liverpool Heart and Chest Hospital 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>
        Prospective case-control study comparing pulsed field ablation for atrial fibrillation under&#xD;
        mild conscious sedation vs standard of care (general anaesthesia).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will prospectively assess 40 patients (20 per arm). Those in the general&#xD;
        anaesthesia arm will undergo routine clinical practice. Those in the mild conscious sedation&#xD;
        arm will undergo pulsed field ablation with intravenous sedation but without general&#xD;
        anaesthesia, though conversion to general anaesthesia is allowed if the patient does not&#xD;
        tolerate the procedure.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 21, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Number and Percentage of Patients Converting to General Anaesthesia in the Conscious Sedation Arm</measure>
      <time_frame>Intraprocedural</time_frame>
      <description>Requirement for conversion to general anaesthesia from mild conscious sedation</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient experience (Pain; Relative)</measure>
      <time_frame>Intraprocedural</time_frame>
      <description>5 point Likert scale for pain during the procedure, 1 = much worse than expected, 5 = much better than expected</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient experience (Discomfort; Relative)</measure>
      <time_frame>Intraprocedural</time_frame>
      <description>5 point Likert scale for discomfort (for example, thumping, heart racing, muscle twitching) during the procedure, 1 = much worse than expected, 5 = much better than expected</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient experience (Anxiety; Relative)</measure>
      <time_frame>Intraprocedural</time_frame>
      <description>5 point Likert scale for anxiety during the procedure, 1 = much worse than expected, 5 = much better than expected</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient experience (Pain; Absolute)</measure>
      <time_frame>Intraprocedural</time_frame>
      <description>Visual analogue score for pain during the procedure (1-100, 1 = none, 100 = worst imaginable)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient experience (Discomfort; Absolute)</measure>
      <time_frame>Intraprocedural</time_frame>
      <description>Visual analogue score for discomfort (for example thumping, heart racing, muscle twitching) during the procedure (1-100, 1 = none, 100 = worst imaginable)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient experience (Anxiety; Absolute)</measure>
      <time_frame>Intraprocedural</time_frame>
      <description>Visual analogue score anxiety during the procedure (1-100, 1 = none, 100 = worst imaginable)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-operative discomfort (Visual analogue score)</measure>
      <time_frame>Immediately after the procedure</time_frame>
      <description>Visual analogue scores for sites post-operative discomfort (groin, chest, throat), (1-100, 1 = none, 100 = worst imaginable)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Friends and family test</measure>
      <time_frame>Immediately after the procedure</time_frame>
      <description>Would the patient recommend the procedure to a friend or family member with the same condition? (5 point Likert scale, 1 = definitely not, 5 = definitely)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acute procedural success</measure>
      <time_frame>Immediately after the procedure</time_frame>
      <description>Were all pulmonary veins isolated at procedure end?</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Procedure Duration</measure>
      <time_frame>During procedure</time_frame>
      <description>Skin-to-skin time - i.e. from first needle insertion to withdrawal of sheaths</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fluoroscopy Duration</measure>
      <time_frame>During procedure</time_frame>
      <description>Time spent with x-ray active</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Left atrial dwell time</measure>
      <time_frame>During procedure</time_frame>
      <description>Time spent with catheters inside the left atrium</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ablation Duration</measure>
      <time_frame>During procedure</time_frame>
      <description>Time from first ablation application to end of final ablation application</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sedative and anaesthetic drug doses</measure>
      <time_frame>During procedure</time_frame>
      <description>Doses of sedatives, analgesics and anaesthetics administered during the procedure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acute Procedural Complications</measure>
      <time_frame>Immediately after the procedure</time_frame>
      <description>Whether any complications occurred</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Same-day discharge rates</measure>
      <time_frame>24 hours</time_frame>
      <description>How many patients per arm went home on the same day as their procedure</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Atrial Fibrillation</condition>
    <arm_group>
      <arm_group_label>Pulsed Field Ablation - General Anaesthesia</arm_group_label>
      <description>Patients undergoing pulsed field ablation for atrial fibrillation under general anaesthetic.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pulsed Field Ablation - Mild Conscious Sedation</arm_group_label>
      <description>Patients undergoing pulsed field ablation for atrial fibrillation under mild conscious sedation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Catheter ablation</intervention_name>
      <description>Catheter ablation of atrial fibrillation</description>
      <arm_group_label>Pulsed Field Ablation - General Anaesthesia</arm_group_label>
      <arm_group_label>Pulsed Field Ablation - Mild Conscious Sedation</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who have been referred clinically for ablation of atrial fibrillation, and will be&#xD;
          undergoing this procedure using pulsed field ablation. Patients will not be randomised in&#xD;
          this feasibility study - the decision to perform the procedure under mild conscious&#xD;
          sedation will be made between the consultant and the patient.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients clinically referred for and undergoing catheter ablation of atrial&#xD;
               fibrillation using pulsed field ablation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to provide informed consent&#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>Dhiraj Gupta, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Liverpool Heart &amp; Chest Hospital NHS Foundation Trust</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Peter Calvert, MBChB</last_name>
      <phone>01516001616</phone>
      <email>peter.calvert@lhch.nhs.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dhiraj Gupta, MD</last_name>
      <phone>01516001616</phone>
      <email>dhiraj.gupta@lhch.nhs.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Liverpool Heart and Chest Hospital</name>
        <address>
          <city>Liverpool</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Peter Calvert, MBChB</last_name>
        <phone>01516001616</phone>
        <email>peter.calvert@lhch.nhs.uk</email>
      </contact>
      <contact_backup>
        <last_name>Dhiraj Gupta, MD</last_name>
        <phone>01516001616</phone>
        <email>dhiraj.gupta@lhch.nhs.uk</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</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>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Anonymised dataset can be made available upon reasonable request. Identifiable data will not be made available for confidentiality reasons.</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/NCT06014814
  org study id: PFA-Sedation-Study
  secondary id: IRAS
  nct id: NCT06014814
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Prospective case-control study comparing pulsed field ablation for atrial fibrillation under
        mild conscious sedation vs standard of care (general anaesthesia).
  This study will prospectively assess 40 patients (20 per arm). Those in the general
        anaesthesia arm will undergo routine clinical practice. Those in the mild conscious sedation
        arm will undergo pulsed field ablation with intravenous sedation but without general
        anaesthesia, though conversion to general anaesthesia is allowed if the patient does not
        tolerate the procedure.
  observational model: Case-Control
  time perspective: Prospective
  measure: Number and Percentage of Patients Converting to General Anaesthesia in the Conscious Sedation Arm
  time frame: Intraprocedural
  description: Requirement for conversion to general anaesthesia from mild conscious sedation
  measure: Patient experience (Pain; Relative)
  time frame: Intraprocedural
  description: 5 point Likert scale for pain during the procedure, 1 = much worse than expected, 5 = much better than expected
  measure: Patient experience (Discomfort; Relative)
  time frame: Intraprocedural
  description: 5 point Likert scale for discomfort (for example, thumping, heart racing, muscle twitching) during the procedure, 1 = much worse than expected, 5 = much better than expected
  measure: Patient experience (Anxiety; Relative)
  time frame: Intraprocedural
  description: 5 point Likert scale for anxiety during the procedure, 1 = much worse than expected, 5 = much better than expected
  measure: Patient experience (Pain; Absolute)
  time frame: Intraprocedural
  description: Visual analogue score for pain during the procedure (1-100, 1 = none, 100 = worst imaginable)
  measure: Patient experience (Discomfort; Absolute)
  time frame: Intraprocedural
  description: Visual analogue score for discomfort (for example thumping, heart racing, muscle twitching) during the procedure (1-100, 1 = none, 100 = worst imaginable)
  measure: Patient experience (Anxiety; Absolute)
  time frame: Intraprocedural
  description: Visual analogue score anxiety during the procedure (1-100, 1 = none, 100 = worst imaginable)
  measure: Post-operative discomfort (Visual analogue score)
  time frame: Immediately after the procedure
  description: Visual analogue scores for sites post-operative discomfort (groin, chest, throat), (1-100, 1 = none, 100 = worst imaginable)
  measure: Friends and family test
  time frame: Immediately after the procedure
  description: Would the patient recommend the procedure to a friend or family member with the same condition? (5 point Likert scale, 1 = definitely not, 5 = definitely)
  measure: Acute procedural success
  time frame: Immediately after the procedure
  description: Were all pulmonary veins isolated at procedure end?
  measure: Procedure Duration
  time frame: During procedure
  description: Skin-to-skin time - i.e. from first needle insertion to withdrawal of sheaths
  measure: Fluoroscopy Duration
  time frame: During procedure
  description: Time spent with x-ray active
  measure: Left atrial dwell time
  time frame: During procedure
  description: Time spent with catheters inside the left atrium
  measure: Ablation Duration
  time frame: During procedure
  description: Time from first ablation application to end of final ablation application
  measure: Sedative and anaesthetic drug doses
  time frame: During procedure
  description: Doses of sedatives, analgesics and anaesthetics administered during the procedure
  measure: Acute Procedural Complications
  time frame: Immediately after the procedure
  description: Whether any complications occurred
  measure: Same-day discharge rates
  time frame: 24 hours
  description: How many patients per arm went home on the same day as their procedure
  arm group label: Pulsed Field Ablation - General Anaesthesia
  description: Patients undergoing pulsed field ablation for atrial fibrillation under general anaesthetic.
  arm group label: Pulsed Field Ablation - Mild Conscious Sedation
  description: Patients undergoing pulsed field ablation for atrial fibrillation under mild conscious sedation.
  intervention type: Procedure
  intervention name: Catheter ablation
  description: Catheter ablation of atrial fibrillation
  arm group label: Pulsed Field Ablation - General Anaesthesia
  arm group label: Pulsed Field Ablation - Mild Conscious Sedation
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Dhiraj Gupta, MD
  role: Study Chair
  affiliation: Liverpool Heart & Chest Hospital NHS Foundation Trust
  last name: Peter Calvert, MBChB
  phone: 01516001616
  email: peter.calvert@lhch.nhs.uk
  last name: Dhiraj Gupta, MD
  phone: 01516001616
  email: dhiraj.gupta@lhch.nhs.uk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Atrial Fibrillation
  sharing ipd: No
  ipd description: Anonymised dataset can be made available upon reasonable request. Identifiable data will not be made available for confidentiality reasons.