Ventricular Arrythmia
Conditions
Keywords
stereotactic radiotherapy
Brief summary
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.
Interventions
RADIATIONStereotactic Antiarrhythmic Radiotherapy
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.
Sponsors
Medical University of Graz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Recurrent VTs/VES with significant burden despite guideline-directed therapy * Existing protective ICD (Implantable cardioverter-defibrillator) implantation except in the presence of contraindications * AND lack of response or intolerance to antiarrhythmic medication * AND status post ≥1 catheter ablation due to monomorphic VT(s) and VT early recurrence (\<12 months after the last catheter ablation) OR contraindication for endocardial ablation (mechanical valve prosthesis, LV (left ventricular) thrombus, or lack of vascular access in suspicion of endocardial substrate) * MINIMAL VT BURDEN: The patient must have had at least 3 VT episodes (sustained VT, ICD-ATP, or ICD shock) in the last 3 months prior to study enrollment. * Presence of suitability for radiation therapy with respect to SBRT * Age ≥ 18 years * Existing informed consent
Exclusion criteria
* Acute myocardial infarction or percutaneous coronary intervention or heart surgery (\<3 months before study enrollment) * Status post intra-thoracic pre-radiation * Immediate proximity to radiosensitive structures (e.g., esophagus) making therapy unsafe to administer * Advanced symptomatic heart failure (NYHA Class IV) * Polymorphic VT or ventricular fibrillation (confirmed in 12-lead ECG and/or ICD interrogation) * Extensive myocardial scar substrate that would result in too large of a radiation volume * Life expectancy \< 6 months considering all comorbidities and in the Seattle Heart Failure Model * Presence of a Left Ventricular Assist Device (LVAD) * Use of cytotoxic medications * Pregnancy or lactation - negative pregnancy test within 14 days before study entry required for women of childbearing potential
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of treatment | 30 days | 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 |
| Efficacy of treatment | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of changes in the left ventricular ejection fraction | 12 months | Evaluation of changes in the left ventricular ejection fraction analyzed with echocardiography |
| Evaluation of mortality | 12 months | Analysis of cardiac mortality during post-treatment follow-up |
| Assessment of late side effects | 12 months | Assessment of radiation-induced cardiac late side effects using late iodine computed tomography |
Countries
Austria
Contacts
Primary ContactTanja Langsenlehner, MD
Outcome results
None listed