The aim of this study is to demonstrate the safety and efficacy of STAR (Stereotactic Antiarrhythmic Radiotherapy) in patients with VT (ventricular tachycardia) who are unresponsive to standard treatments. Additionally, the planned study aims to provide further insights into the effects of STAR on VT burden, ICD interventions, and insights regarding late toxicities, particularly those related to the heart, which are currently not well understood.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Patients with ventricular tachycardia will undergo cardiac stereotactic antiarrhythmic radiotherapy with a single fraction of 25 Gy to the arrhythmia substrate, as determined by electrophysiological cardiac mapping.
Medical University of Graz
Graz, Austria
RECRUITINGSafety of treatment
Demonstration of acute (≤ 30 days) safety of non-invasive stereotactic antiarrhythmic radiotherapy for ventricular arrhythmia (STAR). The primary safety endpoint is defined as ≤ 20% rate of severe adverse events according to CTCAE v5.0 criteria
Time frame: 30 days
Efficacy of treatment
The efficacy endpoint is defined by the number of patients experiencing a reduction in ventricular tachycardia episodes, compared to the six-month period prior to SBRT treatment and the six-month period post- SBRT.
Time frame: 6 months
Evaluation of changes in the left ventricular ejection fraction
Evaluation of changes in the left ventricular ejection fraction analyzed with echocardiography
Time frame: 12 months
Evaluation of mortality
Analysis of cardiac mortality during post-treatment follow-up
Time frame: 12 months
Assessment of late side effects
Assessment of radiation-induced cardiac late side effects using late iodine computed tomography
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.