<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/NCT04499326</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS 264743</org_study_id>
    <nct_id>NCT04499326</nct_id>
  </id_info>
  <brief_title>Improving Patient Reported Outcome Measures in Catheter Ablation</brief_title>
  <official_title>Use of Patient Reported Outcome Measures (PROMs) to Assess Quality of Life and Economic Evaluation of Cardiac Catheter Ablation of Ventricular Tachycardia: a Feasibility and Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barts &amp; The London NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Barts &amp; The London 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 will assess whether more frequent measurement of patient reported outcome measures&#xD;
      (PROMs) - specifically health related quality of life (HRQL) - can improve the evaluation of&#xD;
      the clinical effectiveness and cost-effectiveness of catheter ablation of ventricular&#xD;
      tachycardia (VT) in patients with an Implantable Cardioverter Defibrillator (ICD).&#xD;
&#xD;
      It is designed to have feasibility outcomes which contribute to answering the above.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients who have been implanted with an ICD are at risk of suffering from dangerous&#xD;
      arrhythmias such as VT.&#xD;
&#xD;
      Patients can experience clinical events including worsening of any underlying heart failure&#xD;
      regardless of either VT ablation or medical therapy treatment strategy (anti-arrhythmic drugs&#xD;
      (AAD)). VT ablation is a specialist procedure which has been proven in randomised clinical&#xD;
      trials (RCTs) to confer symptomatic relief from VT, reduced hospitalisations and reduced&#xD;
      shocks from ICDs. However, there is no effect on mortality.&#xD;
&#xD;
      The frequent nature of clinical events in this group of patients may affect their health&#xD;
      status quite dramatically and yet based on current trial evidence, only 3 out of 6 randomised&#xD;
      trials in VT ablation reported PROMs. This can lead to brittle conclusions about the overall&#xD;
      cost-effectiveness profile of a procedure such as VT ablation.&#xD;
&#xD;
      This study will assess for the feasibility of more frequent HRQL monitoring and its impact on&#xD;
      whether it is able to better capture the clinical narrative and quality of life changes of&#xD;
      patients with severe heart failure and an ICD. And thus the assessment of both clinical&#xD;
      effectiveness and cost effectiveness of catheter ablation of VT or continuing anti arrhythmic&#xD;
      drug therapy.&#xD;
&#xD;
      METHOD &amp; SETTING Single centre study at St Bartholomew's Hospital London. Patients will be&#xD;
      identified through established local pathways - there are traditional outpatient specialist&#xD;
      clinics where Consultant Cardiologists receive referrals of patients for consideration of&#xD;
      managing patients with VT, including ablation. In addition, there are joint VT clinics&#xD;
      operated by Consultants as well as by cardiac physiologists. In the outpatient VT clinic, 85&#xD;
      patients were seen in a 10-month window - it is assumed that this scale will allow feasible&#xD;
      identification of patients to be recruited to the both the groups of this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">April 1, 2023</start_date>
  <completion_date type="Anticipated">October 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Completion rate of HRQL forms for patients undergoing VT ablation and those starting or continuing AAD therapy</measure>
    <time_frame>1 year follow up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recruitment rate of patients who fulfil study criteria</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>- Patient preferences for either paper or electronic HQRL (as a percentage of total recruitment)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported HRQL of VT ablation and AAD therapy on both EQ-5D and C-CAP</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact on the cost-effectiveness calculation of VT ablation (using EQ-5D, and a number of different EQ-5D data points)</measure>
    <time_frame>18 months</time_frame>
    <description>Using the Incremental Cost-effectiveness ratio</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Ventricular Tachycardia</condition>
  <condition>ICD</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing catheter ablation of VT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergoing AAD therapy for VT</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Validated quality of life questionnaire (EQ-5D &amp; C-CAP)</intervention_name>
    <description>Patient quality of life to be assessed at baseline, 1, 2, 3, 4, 6, 9 and 12 months</description>
    <arm_group_label>Comparator</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adults (&gt;18 years) With an Implantable Cardioverter Defibrillator (ICD) implanted &gt;3 months&#xD;
        from time of recruitment and a previous episode of documented VT requiring therapy from the&#xD;
        ICD.&#xD;
&#xD;
        And impaired LV/RV function Willing and able to give written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who are planning to move away from study site within 12 months of enrolment who&#xD;
        wished to use postal method to complete their HRQL Patients who are unable to give informed&#xD;
        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>Pier Lambiase, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>UCL</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yang Chen, BM BCh</last_name>
    <phone>02034165000</phone>
    <email>yang.chen@nhs.net</email>
  </overall_contact>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>February 13, 2023</last_update_submitted>
  <last_update_submitted_qc>February 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Catheter ablation</keyword>
  <keyword>Patient reported outcome measure</keyword>
  <keyword>Incremental cost effectiveness ratio</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tachycardia</mesh_term>
    <mesh_term>Tachycardia, Ventricular</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual patient data for outcome measures will be made available</ipd_description>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>In accordance with NHS Research governance framework</ipd_time_frame>
    <ipd_access_criteria>Upon reasonable request</ipd_access_criteria>
  </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/NCT04499326
org study id: IRAS 264743
nct id: NCT04499326
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will assess whether more frequent measurement of patient reported outcome measures
      (PROMs) - specifically health related quality of life (HRQL) - can improve the evaluation of
      the clinical effectiveness and cost-effectiveness of catheter ablation of ventricular
      tachycardia (VT) in patients with an Implantable Cardioverter Defibrillator (ICD).

      It is designed to have feasibility outcomes which contribute to answering the above.
Patients who have been implanted with an ICD are at risk of suffering from dangerous
      arrhythmias such as VT.

      Patients can experience clinical events including worsening of any underlying heart failure
      regardless of either VT ablation or medical therapy treatment strategy (anti-arrhythmic drugs
      (AAD)). VT ablation is a specialist procedure which has been proven in randomised clinical
      trials (RCTs) to confer symptomatic relief from VT, reduced hospitalisations and reduced
      shocks from ICDs. However, there is no effect on mortality.

      The frequent nature of clinical events in this group of patients may affect their health
      status quite dramatically and yet based on current trial evidence, only 3 out of 6 randomised
      trials in VT ablation reported PROMs. This can lead to brittle conclusions about the overall
      cost-effectiveness profile of a procedure such as VT ablation.

      This study will assess for the feasibility of more frequent HRQL monitoring and its impact on
      whether it is able to better capture the clinical narrative and quality of life changes of
      patients with severe heart failure and an ICD. And thus the assessment of both clinical
      effectiveness and cost effectiveness of catheter ablation of VT or continuing anti arrhythmic
      drug therapy.

      METHOD & SETTING Single centre study at St Bartholomew's Hospital London. Patients will be
      identified through established local pathways - there are traditional outpatient specialist
      clinics where Consultant Cardiologists receive referrals of patients for consideration of
      managing patients with VT, including ablation. In addition, there are joint VT clinics
      operated by Consultants as well as by cardiac physiologists. In the outpatient VT clinic, 85
      patients were seen in a 10-month window - it is assumed that this scale will allow feasible
      identification of patients to be recruited to the both the groups of this study.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Completion rate of HRQL forms for patients undergoing VT ablation and those starting or continuing AAD therapy
time frame: 1 year follow up
measure: Recruitment rate of patients who fulfil study criteria
time frame: 1 year
measure: - Patient preferences for either paper or electronic HQRL (as a percentage of total recruitment)
time frame: 1 year
measure: Patient reported HRQL of VT ablation and AAD therapy on both EQ-5D and C-CAP
time frame: 18 months
measure: Impact on the cost-effectiveness calculation of VT ablation (using EQ-5D, and a number of different EQ-5D data points)
time frame: 18 months
description: Using the Incremental Cost-effectiveness ratio
arm group label: Intervention
arm group type: Experimental
description: Patients undergoing catheter ablation of VT
arm group label: Comparator
arm group type: Active Comparator
description: Patients undergoing AAD therapy for VT
intervention type: Other
intervention name: Validated quality of life questionnaire (EQ-5D & C-CAP)
description: Patient quality of life to be assessed at baseline, 1, 2, 3, 4, 6, 9 and 12 months
arm group label: Comparator
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pier Lambiase, PhD
role: Study Chair
affiliation: UCL
last name: Yang Chen, BM BCh
phone: 02034165000
email: yang.chen@nhs.net
responsible party type: Sponsor
mesh term: Tachycardia
mesh term: Tachycardia, Ventricular
sharing ipd: Yes
ipd description: De-identified individual patient data for outcome measures will be made available
ipd info type: Clinical Study Report (CSR)
ipd time frame: In accordance with NHS Research governance framework
ipd access criteria: Upon reasonable request