Cardiac RadiothErapy for VEntricular Tachycardia

Ventricular Tachycardia Clinical Trial

— CREVET  

Official title:

Cardiac RadiothErapy for VEntricular Tachycardia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05973578
• Other study ID #: s66934
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2023
• Est. completion date: May 1, 2026

Study information

• Verified date: May 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Patrick Berkovic, MD, PhD
• Phone: +32-16-34-51-15
• Email: Patrick.berkovic[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: May 1, 2026
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Radiation:
• Stereotactic radiotherapy
Single-session high dose stereotactic radiotherapy

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From date of inclusion up to 1 year
Primary	Safety of SBRT	Measurement of acute and late toxicity assessed using the CTCAE v5.0	From radiotherapy up to 1 year
Secondary	Efficacy of SBRT	Changes in the use of antiarrhythmic medication, reduction in VT burden	From inclusion up to 1 year
Secondary	Health related quality-of-life	Measurement of the quality of life using the SF-36 questionnaire	From inclusion up to 1 year