Back to resultsCardiac RadiothErapy for VEntricular Tachycardia (CREVET)
Primary Purpose
Ventricular Tachycardia
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Stereotactic radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Tachycardia
Eligibility Criteria
Inclusion Criteria: Patient ≥ 18 years Presence of a structural heart disease and an implantable cardioverter defibrillator (ICD) Documented sustained monomorphic VT that requires ICD intervention (e.g., shock or anti-tachycardia stimulation) The VT is inducible by ICD via non-invasive programmed stimulation (NIPS) or during electrophysiology measurement Patient must have failed or become intolerant to at least one antiarrhythmic medication Patient must have failed at least one invasive catheter ablation procedure, or have a contraindication to a catheter ablation procedure, or have VT thought to arise from a protected location Ability to give a written informed consent and willingness to return for follow-up Exclusion Criteria: Pregnancy or breastfeeding Lack of evidence of a myocardial scar triggering the VT Polymorphic VT or ventricular fibrillation (VF) as a clinical heart rhythm Advanced symptomatic heart failure defined as NYHA Class IV heart failure Previous radiotherapy with cardiac involvement Life expectancy < 6 months, in the absence of VT, as best based on clinical judgment by the treating and enrolling physicians Any condition that is deemed a contraindication in the judgment of the investigators
Sites / Locations
- UZ LeuvenRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Stereotactic body radiotherapy
Arm 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
Outcomes
Primary Outcome Measures
Feasibility of SBRT
Successful irradiation process (collaboration with cardiologist and radiologist), measured by the end-to-end delivery of SBRT to at least 1 patient
Safety of SBRT
Measurement of acute and late toxicity assessed using the CTCAE v5.0
Secondary Outcome Measures
Efficacy of SBRT
Changes in the use of antiarrhythmic medication, reduction in VT burden
Health related quality-of-life
Measurement of the quality of life using the SF-36 questionnaire
Full Information
NCT ID
NCT05973578
First Posted
May 2, 2023
Last Updated
July 31, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT05973578
Brief Title
Cardiac RadiothErapy for VEntricular Tachycardia
Acronym
CREVET
Official Title
Cardiac RadiothErapy for VEntricular Tachycardia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stereotactic body radiotherapy
Arm Type
Other
Arm 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(s)
Stereotactic radiotherapy
Intervention Description
Single-session high dose stereotactic radiotherapy
Primary Outcome Measure Information:
Title
Feasibility of SBRT
Description
Successful irradiation process (collaboration with cardiologist and radiologist), measured by the end-to-end delivery of SBRT to at least 1 patient
Time Frame
From date of inclusion up to 1 year
Title
Safety of SBRT
Description
Measurement of acute and late toxicity assessed using the CTCAE v5.0
Time Frame
From radiotherapy up to 1 year
Secondary Outcome Measure Information:
Title
Efficacy of SBRT
Description
Changes in the use of antiarrhythmic medication, reduction in VT burden
Time Frame
From inclusion up to 1 year
Title
Health related quality-of-life
Description
Measurement of the quality of life using the SF-36 questionnaire
Time Frame
From inclusion up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient ≥ 18 years
Presence of a structural heart disease and an implantable cardioverter defibrillator (ICD)
Documented sustained monomorphic VT that requires ICD intervention (e.g., shock or anti-tachycardia stimulation)
The VT is inducible by ICD via non-invasive programmed stimulation (NIPS) or during electrophysiology measurement
Patient must have failed or become intolerant to at least one antiarrhythmic medication
Patient must have failed at least one invasive catheter ablation procedure, or have a contraindication to a catheter ablation procedure, or have VT thought to arise from a protected location
Ability to give a written informed consent and willingness to return for follow-up
Exclusion Criteria:
Pregnancy or breastfeeding
Lack of evidence of a myocardial scar triggering the VT
Polymorphic VT or ventricular fibrillation (VF) as a clinical heart rhythm
Advanced symptomatic heart failure defined as NYHA Class IV heart failure
Previous radiotherapy with cardiac involvement
Life expectancy < 6 months, in the absence of VT, as best based on clinical judgment by the treating and enrolling physicians
Any condition that is deemed a contraindication in the judgment of the investigators
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Berkovic, MD, PhD
Phone
+32-16-34-51-15
Email
Patrick.berkovic@uzleuven.be
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Berkovic, MD, PhD
First Name & Middle Initial & Last Name & Degree
Patrick Berkovic, MD, PhD
First Name & Middle Initial & Last Name & Degree
Bert Vandenberk, MD, PhD
First Name & Middle Initial & Last Name & Degree
Joris Ector, MD, PhD
First Name & Middle Initial & Last Name & Degree
Cédric Draulans, MD, PhD
First Name & Middle Initial & Last Name & Degree
Kenneth Poels, MSc, PhD
First Name & Middle Initial & Last Name & Degree
Robin De Roover, MSc, PhD
First Name & Middle Initial & Last Name & Degree
Jan Bogaert, MD, PhD
First Name & Middle Initial & Last Name & Degree
Steven Dymarkowski, MD, PhD
First Name & Middle Initial & Last Name & Degree
Walter Coudyzer, MSc
12. IPD Sharing Statement
Plan to Share IPD
No
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Cardiac RadiothErapy for VEntricular Tachycardia
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