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/NCT05973578</url>
    </required_header>
    <id_info>
      <org_study_id>s66934</org_study_id>
      <nct_id>NCT05973578</nct_id>
    </id_info>
    <brief_title>Cardiac RadiothErapy for VEntricular Tachycardia</brief_title>
    <acronym>CREVET</acronym>
    <official_title>Cardiac RadiothErapy for VEntricular Tachycardia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitaire Ziekenhuizen KU Leuven</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitaire Ziekenhuizen KU Leuven</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>
        Objective: To explore in our center the feasibility and safety of a SBRT treatment method for&#xD;
        VT.&#xD;
  &#xD;
        Study population: Patients with ventricular tachycardia that are refractory to dose-escalated&#xD;
        antiarrhythmic drugs and where catheter ablation has either already been performed or is&#xD;
        deemed to be unsuccessful or associated with high risks.&#xD;
  &#xD;
        Intervention: Patients will be treated with a stereotactic body radiotherapy technique as a&#xD;
        single fraction treatment up to a dose of 25 Gy delivered to the VT substrate defined by&#xD;
        electrophysiological mapping.&#xD;
  &#xD;
        Main study endpoints: The primary aim is to explore the feasibility and safety of a SBRT&#xD;
        treatment method for refractory VT. Secondary endpoints include an assessment of the efficacy&#xD;
        of the treatment, quality of life, late toxicity and overall survival.&#xD;
  &#xD;
        Patients will have to fill in a quality-of-life questionnaire before and after the&#xD;
        radiotherapy treatment. The risk associated with this trial is an increase in toxicity.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 23, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2025</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility of SBRT</measure>
      <time_frame>From date of inclusion up to 1 year</time_frame>
      <description>Successful irradiation process (collaboration with cardiologist and radiologist), measured by the end-to-end delivery of SBRT to at least 1 patient</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Safety of SBRT</measure>
      <time_frame>From radiotherapy up to 1 year</time_frame>
      <description>Measurement of acute and late toxicity assessed using the CTCAE v5.0</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Efficacy of SBRT</measure>
      <time_frame>From inclusion up to 1 year</time_frame>
      <description>Changes in the use of antiarrhythmic medication, reduction in VT burden</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health related quality-of-life</measure>
      <time_frame>From inclusion up to 1 year</time_frame>
      <description>Measurement of the quality of life using the SF-36 questionnaire</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">5</enrollment>
    <condition>Ventricular Tachycardia</condition>
    <arm_group>
      <arm_group_label>Stereotactic body radiotherapy</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients will be treated with a stereotactic body radiotherapy technique as a single fraction treatment up to a dose of 25 Gy delivered to the VT substrate</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Stereotactic radiotherapy</intervention_name>
      <description>Single-session high dose stereotactic radiotherapy</description>
      <arm_group_label>Stereotactic body radiotherapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient ≥ 18 years&#xD;
  &#xD;
            -  Presence of a structural heart disease and an implantable cardioverter defibrillator&#xD;
               (ICD)&#xD;
  &#xD;
            -  Documented sustained monomorphic VT that requires ICD intervention (e.g., shock or&#xD;
               anti-tachycardia stimulation)&#xD;
  &#xD;
            -  The VT is inducible by ICD via non-invasive programmed stimulation (NIPS) or during&#xD;
               electrophysiology measurement&#xD;
  &#xD;
            -  Patient must have failed or become intolerant to at least one antiarrhythmic&#xD;
               medication&#xD;
  &#xD;
            -  Patient must have failed at least one invasive catheter ablation procedure, or have a&#xD;
               contraindication to a catheter ablation procedure, or have VT thought to arise from a&#xD;
               protected location&#xD;
  &#xD;
            -  Ability to give a written informed consent and willingness to return for follow-up&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy or breastfeeding&#xD;
  &#xD;
            -  Lack of evidence of a myocardial scar triggering the VT&#xD;
  &#xD;
            -  Polymorphic VT or ventricular fibrillation (VF) as a clinical heart rhythm&#xD;
  &#xD;
            -  Advanced symptomatic heart failure defined as NYHA Class IV heart failure&#xD;
  &#xD;
            -  Previous radiotherapy with cardiac involvement&#xD;
  &#xD;
            -  Life expectancy &lt; 6 months, in the absence of VT, as best based on clinical judgment&#xD;
               by the treating and enrolling physicians&#xD;
  &#xD;
            -  Any condition that is deemed a contraindication in the judgment of the investigators&#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_contact>
      <last_name>Patrick Berkovic, MD, PhD</last_name>
      <phone>+32-16-34-51-15</phone>
      <email>Patrick.berkovic@uzleuven.be</email>
    </overall_contact>
    <location>
      <facility>
        <name>UZ Leuven</name>
        <address>
          <city>Leuven</city>
          <zip>3000</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Patrick Berkovic, MD, PhD</last_name>
      </contact>
      <investigator>
        <last_name>Patrick Berkovic, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Bert Vandenberk, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Joris Ector, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Cédric Draulans, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Kenneth Poels, MSc, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Robin De Roover, MSc, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jan Bogaert, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Steven Dymarkowski, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Walter Coudyzer, MSc</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>May 2, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 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>Tachycardia</mesh_term>
      <mesh_term>Tachycardia, Ventricular</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05973578
  org study id: s66934
  nct id: NCT05973578
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Objective: To explore in our center the feasibility and safety of a SBRT treatment method for
        VT.
  
        Study population: Patients with ventricular tachycardia that are refractory to dose-escalated
        antiarrhythmic drugs and where catheter ablation has either already been performed or is
        deemed to be unsuccessful or associated with high risks.
  
        Intervention: Patients will be treated with a stereotactic body radiotherapy technique as a
        single fraction treatment up to a dose of 25 Gy delivered to the VT substrate defined by
        electrophysiological mapping.
  
        Main study endpoints: The primary aim is to explore the feasibility and safety of a SBRT
        treatment method for refractory VT. Secondary endpoints include an assessment of the efficacy
        of the treatment, quality of life, late toxicity and overall survival.
  
        Patients will have to fill in a quality-of-life questionnaire before and after the
        radiotherapy treatment. The risk associated with this trial is an increase in toxicity.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Feasibility of SBRT
  time frame: From date of inclusion up to 1 year
  description: Successful irradiation process (collaboration with cardiologist and radiologist), measured by the end-to-end delivery of SBRT to at least 1 patient
  measure: Safety of SBRT
  time frame: From radiotherapy up to 1 year
  description: Measurement of acute and late toxicity assessed using the CTCAE v5.0
  measure: Efficacy of SBRT
  time frame: From inclusion up to 1 year
  description: Changes in the use of antiarrhythmic medication, reduction in VT burden
  measure: Health related quality-of-life
  time frame: From inclusion up to 1 year
  description: Measurement of the quality of life using the SF-36 questionnaire
  arm group label: Stereotactic body radiotherapy
  arm group type: Other
  description: Patients will be treated with a stereotactic body radiotherapy technique as a single fraction treatment up to a dose of 25 Gy delivered to the VT substrate
  intervention type: Radiation
  intervention name: Stereotactic radiotherapy
  description: Single-session high dose stereotactic radiotherapy
  arm group label: Stereotactic body radiotherapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Patrick Berkovic, MD, PhD
  phone: +32-16-34-51-15
  email: Patrick.berkovic@uzleuven.be
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Belgium
  responsible party type: Sponsor
  mesh term: Tachycardia
  mesh term: Tachycardia, Ventricular
  sharing ipd: No