Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias
Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias
Patients with refractory ventricular extrasystoles or tachycardia not eligible for catheter
 ablation will receive single fraction stereotactic body radiation therapy (cardiac
 radiosurgery) with 25 Gy.

 Investigators initiated this study to demonstrate that in at least 70% of the patients the
 planned cardiac radiosurgery may be performed without any interruption or treatment related
 interventional events within the first 30 days after treatment.
Primary endpoint: 30-day post-intervention safety defined as presence of both, radiosurgery
 delivery of the planned dose to the intended target area, and no possibly treatment related
 serious adverse events in the first 30 days after treatment.

 Secondary endpoints: evaluated at 1 year

 -  Changes in ventricular tachycardia episodes and ICD shocks

 -  Changes in antiarrhythmic medication due to treatment effects

 -  Occurrence of possibly treatment related adverse events in the first year after
 treatment (according to CTCAE v5.0)

 -  Changes in patient-reported quality of life (recorded as EQ-5D-5L)

 -  Overall survival

 -  Safety profile
Inclusion Criteria:

 -  Patients with structural heart disease and implantable cardioverter defibrillator
 (ICD)

 -  Age > 18 years

 -  either

 1. Recurring symptomatic monomorphic ventricular tachycardia that requires ICD
 intervention (e.g. shock or anti-tachycardia stimulation). At least 3 episodes
 within the 3 months prior to inclusion or

 2. induction of symptomatic monomorphic ventricular tachycardia that requires ICD
 intervention (e.g. shock or anti-tachycardia stimulation). Induction triggered by
 ICD or during electrophysiology studies (EPS) or both, a) and b)

 -  Refractory to antiarrhythmic combination therapy

 -  Beside the cardiac conditions: No competing illness that would additionally limit the
 life expectancy to less than 6 months

 -  No prior radiation therapy in the thorax area

 -  No pregnancy and no active breastfeeding

 -  Ability to consent and consent to study participation

 Exclusion Criteria:

 -  ICD electrode malfunction of ICD readings outside reference range

 -  Lack of evidence of a myocardial scar (Computer tomography or magnetic resonance
 tomography for MRI-capable ICD aggregates or electrophysiological measurement)

 -  No possible induction of symptomatic monomorphic ventricular tachycardia
 non-persistent or persistent with delivery of ICD therapies such as antitachycardic
 pacing or shock

 -  Contraindication to radiosurgery (e.g. precise target volume definition not possible
 due to image artifacts created from a left ventricular assist device [LVAD])

 -  Inability to consent or missing or withdrawn consent