Stereotactic radiotherapy for treating ventricular tachycardia
Cardiac RadiothErapy for VEntricular Tachycardia
This study is testing if a special type of radiation therapy can safely help people with hard-to-treat ventricular tachycardia feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT05973578 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility and safety of using stereotactic body radiotherapy (SBRT) as a treatment for patients with ventricular tachycardia (VT) that is resistant to conventional antiarrhythmic drugs. Participants will receive a single fraction of SBRT, delivering up to 25 Gy to the VT substrate identified through electrophysiological mapping. The study will assess not only the safety and feasibility of this approach but also its efficacy, quality of life impacts, late toxicity, and overall survival rates. Patients will complete quality-of-life questionnaires before and after treatment to measure any changes.
Who should consider this trial
Good fit: Ideal candidates are adults with structural heart disease and an implantable cardioverter defibrillator who have not responded to antiarrhythmic medications or catheter ablation.
Not a fit: Patients with polymorphic ventricular tachycardia, advanced heart failure, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients with refractory ventricular tachycardia who have limited alternatives.
How similar studies have performed: While the use of SBRT for VT is a novel approach, similar studies exploring radiotherapy for cardiac arrhythmias have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leuven
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Study coordinator: Patrick Berkovic, MD, PhD
- Email: Patrick.berkovic@uzleuven.be
- Phone: +32-16-34-51-15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.