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/NCT06028919</url>
    </required_header>
    <id_info>
      <org_study_id>TS584122</org_study_id>
      <nct_id>NCT06028919</nct_id>
    </id_info>
    <brief_title>A Randomised Control Trial of Power Versus Temperature-controlled Irrigated Radiofrequency Ablation for the Treatment of Ventricular Tachycardia</brief_title>
    <acronym>DTinVT</acronym>
    <official_title>A Randomised Control Trial of Power Versus Temperature-controlled Irrigated Radiofrequency Ablation for the Treatment of Ventricular Tachycardia (VT)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospitals Coventry and Warwickshire NHS Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Medtronic</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>Coventry University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospitals Coventry and Warwickshire 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>
        Ventricular Tachycardia (VT) is a life threatening heart rhythm that comes from the bottom&#xD;
        chambers of the heart (the ventricles) and is a leading cause of sudden cardiac death.&#xD;
  &#xD;
        The majority of patients that are at risk of VT or suffer a cardiac arrest will have an&#xD;
        Internal Cardiac Defibrillator (ICD) in situ to treat the abnormal heart rhythm. The ICD can&#xD;
        deliver a painful shock to restore normal heart rhythm but importantly does not treat the&#xD;
        underlying cause. Current treatment for the prevention of recurrent VT include catheter&#xD;
        ablation (CA) or medication. Long-term results with global 12 month VT-free survival rates&#xD;
        with CA are around 50%.&#xD;
  &#xD;
        The trial is to compare 2 different types of ablation catheter that are used to cauterise&#xD;
        small areas of unhealthy tissue within the heart that are responsible for VT: Diamond Temp&#xD;
        (DT) and Tacticath/Tactiflex (TF). Our hypothesis is that the DT ablation catheter will&#xD;
        provide comparable efficacy and safety for the treatment of VT as the current industry gold&#xD;
        standard (TF).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This trial compares 2 different types of ablation catheter for the treatment of ventricular&#xD;
        tachycardia (VT). VT is a life threatening heart rhythm that comes from the bottom chambers&#xD;
        of the heart (the ventricles) and is associated with poor patient prognosis, outcomes and is&#xD;
        a leading cause of sudden cardiac death in developed countries.&#xD;
  &#xD;
        Current treatments for VT include catheter ablation (CA), medication and having an internal&#xD;
        cardiac defibrillator (ICD) implanted, each treatment has advantages and disadvantages. The&#xD;
        ICD can deliver a lifesaving shock but this doesn't treat the cause of the VT and can be very&#xD;
        painful and upsetting for the patient. Medications can reduce the amount and rate of VT but&#xD;
        can have dangerous side effects.&#xD;
  &#xD;
        CA involves small tubes being placed in the heart and small areas of unhealthy heart tissue&#xD;
        are burnt (ablated) to stop the VT. This is the only treatment that treats the underlying&#xD;
        cause but long-term success is about 50% after 1 year.&#xD;
  &#xD;
        We want to improve the success rates of VT ablation. There is a new ablation catheter called&#xD;
        Diamond Temp which works differently to the current industry gold standard&#xD;
        (Tacticath/Tactiflex Catheter). We think the Diamond Temp catheter will be better than the&#xD;
        Tacticath catheter but need to do this trial to prove it.&#xD;
  &#xD;
        This trial will be at University Hospital Coventry and Warwickshire and University Hospitals&#xD;
        Sussex involving patients that suffer VT, have an ICD and need an ablation. If a patient&#xD;
        wishes to participate they will give consent and be chosen at random to receive ablation with&#xD;
        either Diamond temp or Tacticath/Tactiflex. All other treatment will be the same as after a&#xD;
        normal ablation procedure. Participants will be followed up at 6 months and 1 year after the&#xD;
        procedure as well as being monitored by the ICD clinic. The study will have 54 patients and&#xD;
        be completed in 2025.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2022</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">May 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>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>patient-blinded, prospective, multi centre, two-arm, randomised controlled trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>The patient will be blinded to which trial arm they have been assigned.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Assessing the efficacy of the DT versus the TF ablation catheter for the treatment of VT</measure>
      <time_frame>12 months post ablation</time_frame>
      <description>The efficacy of each ablation catheter will be compared by measuring the VT burden 12 months post-ablation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessing the safety of the DT versus the TF ablation catheter for the treatment of VT</measure>
      <time_frame>within 30 days or 6 months after index ablation procedure</time_frame>
      <description>The efficacy of each ablation catheter will be compared by measuring the freedom from a composite of pre-specified procedure-related complications (adverse outcomes).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Perceived health benefit of treatment</measure>
      <time_frame>at baseline and 12 months</time_frame>
      <description>The patient's health benefit will be measured using a EQ-5D-5L questionnaire.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Ventricular Tachycardia</condition>
    <arm_group>
      <arm_group_label>Temperature controlled DiamondTemp (DT) ablation catheter</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Intervention arm</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Power controlled Tacticath/Tactiflex ablation catheter</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Control arm</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Temperature controlled DiamondTemp (DT) ablation catheter</intervention_name>
      <description>The DiamondTemp catheter is a new ablation catheter that uses 6 industrial grade diamonds to actually measure the temperature of the surface tissue being cauterised. This enables the DiamondTemp catheter to control the amount of power being delivered from the ablation catheter into the tissue being ablated by maintaining a constant temperature at the surface of the heart.</description>
      <arm_group_label>Temperature controlled DiamondTemp (DT) ablation catheter</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Tacticath/Tactiflex (TF) ablation catheter</intervention_name>
      <description>The Tactiflex ablation catheter is currently the market leader and routinely used for VT ablation.</description>
      <arm_group_label>Power controlled Tacticath/Tactiflex ablation catheter</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ≥ 18 years of age to give informed consent specific to national legal requirements.&#xD;
  &#xD;
            -  Subject with 1 of the following:&#xD;
  &#xD;
                 1. Symptomatic VT (despite optimal medical therapy), 3 or more episodes of VT within&#xD;
                    24 h (VT storm).&#xD;
  &#xD;
                 2. At least 3 episodes of VT requiring anti-tachycardia pacing (ATP)&#xD;
  &#xD;
                 3. At least one appropriate ICD shock.&#xD;
  &#xD;
            -  Referred for VT ablation by Consultant Electrophysiologist&#xD;
  &#xD;
            -  Subject discussed at cardiac EP MDT&#xD;
  &#xD;
            -  Suitable candidate for intra-cardiac mapping and ablation of arrhythmia.&#xD;
  &#xD;
            -  Subject agrees to comply with study procedures and be available for routine follow up&#xD;
               visits for at least 12 months after enrolment.&#xD;
  &#xD;
            -  Subject is willing and able to provide written consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  BMI &gt;40kg/m2&#xD;
  &#xD;
            -  Presence of intramural thrombus, tumour or abnormality that precludes vascular access,&#xD;
               catheter introduction or manipulations.&#xD;
  &#xD;
            -  Coagulopathy, bleeding diathesis or suspected pro-coagulant state.&#xD;
  &#xD;
            -  Sepsis, active systemic infection or fever (&gt;100.5 F/38 C) within a week prior to the&#xD;
               ablation procedure.&#xD;
  &#xD;
            -  Significant restrictive or obstructive pulmonary disease or chronic respiratory&#xD;
               condition.&#xD;
  &#xD;
            -  Renal failure requiring dialysis or renal compromise that in the investigators&#xD;
               judgement would increase risk to the subject or deem the subject inappropriate to&#xD;
               participate in the study.&#xD;
  &#xD;
            -  Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used&#xD;
               in conjunction with the study or contrast sensitivity that can't be adequately&#xD;
               pre-treated prior to the ablation procedure.&#xD;
  &#xD;
            -  Positive pregnancy test results for female subjects of childbearing or potential or&#xD;
               breast feeding.&#xD;
  &#xD;
            -  Enrolment in a concurrent clinical study that in the judgement of the investigator&#xD;
               would increase risk to the subject or deem the subject inappropriate to participate in&#xD;
               the study.&#xD;
  &#xD;
            -  Significant GI bleed.&#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>Tarv Dhanjal, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospitals Coventry and Warwickshire NHS Trust</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tarv Dhanjal, PhD</last_name>
      <phone>02476 965668</phone>
      <email>Tarv.dhanjal@uhcw.nhs.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Cristiana Huhulea, MSc</last_name>
      <phone>024 7696 7476</phone>
      <email>Dtinvt@uhcw.nhs.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Hospital Coventry and Warwickshire NHS Trust</name>
        <address>
          <city>Coventry</city>
          <state>West Midlands</state>
          <zip>CV22DX</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cristiana Huhulea, MSc</last_name>
        <phone>024 7696 7476</phone>
        <phone_ext>27476</phone_ext>
        <email>cristiana.huhulea@uhcw.nhs.uk</email>
      </contact>
      <contact_backup>
        <last_name>Violet Matthews, BA</last_name>
        <phone>024 7696 6197</phone>
        <phone_ext>26197</phone_ext>
        <email>Violet.Matthews@uhcw.nhs.uk</email>
      </contact_backup>
      <investigator>
        <last_name>Tarv Dhanjal, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>temperature controlled irrigated radiofrequency ablation</keyword>
    <keyword>ventricular tachycardia</keyword>
    <keyword>clinical outcomes</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>No</sharing_ipd>
      <ipd_description>Individual participant data will not be made available to other researchers.</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/NCT06028919
  org study id: TS584122
  nct id: NCT06028919
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Ventricular Tachycardia (VT) is a life threatening heart rhythm that comes from the bottom
        chambers of the heart (the ventricles) and is a leading cause of sudden cardiac death.
  
        The majority of patients that are at risk of VT or suffer a cardiac arrest will have an
        Internal Cardiac Defibrillator (ICD) in situ to treat the abnormal heart rhythm. The ICD can
        deliver a painful shock to restore normal heart rhythm but importantly does not treat the
        underlying cause. Current treatment for the prevention of recurrent VT include catheter
        ablation (CA) or medication. Long-term results with global 12 month VT-free survival rates
        with CA are around 50%.
  
        The trial is to compare 2 different types of ablation catheter that are used to cauterise
        small areas of unhealthy tissue within the heart that are responsible for VT: Diamond Temp
        (DT) and Tacticath/Tactiflex (TF). Our hypothesis is that the DT ablation catheter will
        provide comparable efficacy and safety for the treatment of VT as the current industry gold
        standard (TF).
  This trial compares 2 different types of ablation catheter for the treatment of ventricular
        tachycardia (VT). VT is a life threatening heart rhythm that comes from the bottom chambers
        of the heart (the ventricles) and is associated with poor patient prognosis, outcomes and is
        a leading cause of sudden cardiac death in developed countries.
  
        Current treatments for VT include catheter ablation (CA), medication and having an internal
        cardiac defibrillator (ICD) implanted, each treatment has advantages and disadvantages. The
        ICD can deliver a lifesaving shock but this doesn't treat the cause of the VT and can be very
        painful and upsetting for the patient. Medications can reduce the amount and rate of VT but
        can have dangerous side effects.
  
        CA involves small tubes being placed in the heart and small areas of unhealthy heart tissue
        are burnt (ablated) to stop the VT. This is the only treatment that treats the underlying
        cause but long-term success is about 50% after 1 year.
  
        We want to improve the success rates of VT ablation. There is a new ablation catheter called
        Diamond Temp which works differently to the current industry gold standard
        (Tacticath/Tactiflex Catheter). We think the Diamond Temp catheter will be better than the
        Tacticath catheter but need to do this trial to prove it.
  
        This trial will be at University Hospital Coventry and Warwickshire and University Hospitals
        Sussex involving patients that suffer VT, have an ICD and need an ablation. If a patient
        wishes to participate they will give consent and be chosen at random to receive ablation with
        either Diamond temp or Tacticath/Tactiflex. All other treatment will be the same as after a
        normal ablation procedure. Participants will be followed up at 6 months and 1 year after the
        procedure as well as being monitored by the ICD clinic. The study will have 54 patients and
        be completed in 2025.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: patient-blinded, prospective, multi centre, two-arm, randomised controlled trial
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: The patient will be blinded to which trial arm they have been assigned.
  measure: Assessing the efficacy of the DT versus the TF ablation catheter for the treatment of VT
  time frame: 12 months post ablation
  description: The efficacy of each ablation catheter will be compared by measuring the VT burden 12 months post-ablation.
  measure: Assessing the safety of the DT versus the TF ablation catheter for the treatment of VT
  time frame: within 30 days or 6 months after index ablation procedure
  description: The efficacy of each ablation catheter will be compared by measuring the freedom from a composite of pre-specified procedure-related complications (adverse outcomes).
  measure: Perceived health benefit of treatment
  time frame: at baseline and 12 months
  description: The patient's health benefit will be measured using a EQ-5D-5L questionnaire.
  arm group label: Temperature controlled DiamondTemp (DT) ablation catheter
  arm group type: Other
  description: Intervention arm
  arm group label: Power controlled Tacticath/Tactiflex ablation catheter
  arm group type: Other
  description: Control arm
  intervention type: Device
  intervention name: Temperature controlled DiamondTemp (DT) ablation catheter
  description: The DiamondTemp catheter is a new ablation catheter that uses 6 industrial grade diamonds to actually measure the temperature of the surface tissue being cauterised. This enables the DiamondTemp catheter to control the amount of power being delivered from the ablation catheter into the tissue being ablated by maintaining a constant temperature at the surface of the heart.
  arm group label: Temperature controlled DiamondTemp (DT) ablation catheter
  intervention type: Device
  intervention name: Tacticath/Tactiflex (TF) ablation catheter
  description: The Tactiflex ablation catheter is currently the market leader and routinely used for VT ablation.
  arm group label: Power controlled Tacticath/Tactiflex ablation catheter
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Tarv Dhanjal, PhD
  role: Principal Investigator
  affiliation: University Hospitals Coventry and Warwickshire NHS Trust
  last name: Tarv Dhanjal, PhD
  phone: 02476 965668
  email: Tarv.dhanjal@uhcw.nhs.uk
  last name: Cristiana Huhulea, MSc
  phone: 024 7696 7476
  email: Dtinvt@uhcw.nhs.uk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Tachycardia
  mesh term: Tachycardia, Ventricular
  sharing ipd: No
  ipd description: Individual participant data will not be made available to other researchers.