Cardiac RadiothErapy for VEntricular Tachycardia

Not Applicable

Recruiting

• Conditions: Ventricular Tachycardia
• Interventions: Radiation: Stereotactic radiotherapy

• Registration Number: NCT05973578
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-02
• Study Start: 2023-05-23
• Study First Submitted QC: 2023-07-31
• Last Update Submitted: 2023-07-31
• Study First Posted: 2023-08-03
• Last Update Posted: 2023-08-03
• Primary Completion: 2025-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic body radiotherapy	Stereotactic radiotherapy	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

Primary Outcome Measures

Name	Time	Method
Safety of SBRT	From radiotherapy up to 1 year	Measurement of acute and late toxicity assessed using the CTCAE v5.0
Feasibility of SBRT	From date of inclusion up to 1 year	Successful irradiation process (collaboration with cardiologist and radiologist), measured by the end-to-end delivery of SBRT to at least 1 patient

Secondary Outcome Measures

Name	Time	Method
Health related quality-of-life	From inclusion up to 1 year	Measurement of the quality of life using the SF-36 questionnaire
Efficacy of SBRT	From inclusion up to 1 year	Changes in the use of antiarrhythmic medication, reduction in VT burden

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium