Ventricular Tachycardia Clinical Trial
Official title:
Radiosurgery for the Treatment of Refractory Ventricular Extrasystoles and Tachycardias (RAVENTA)
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 ;
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