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 * Changes in patient-reported quality of life * Overall survival * Safety profile
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Image-guided stereotactic body radiation therapy
University Clinic Mannheim
Mannheim, Baden-Wurttemberg, Germany
Hospital of the Ludwig-Maximilians-University Munich
Munich, Bavaria, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
University Medical Center Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany
Acute toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports
Time frame: 30 days after radiosurgery
Late toxicity analysed by Adverse Event (AE)- and Serious Adverse Event (SAE)-reports
Time frame: 12 months after radiosurgery
Ventricular tachycardia burden reduction analysed by number of episodes and ICD shocks
Time frame: At the time of inclusion and 12 months after radiosurgery
Overall Survival
Time frame: 12 months after radiosurgery
Quality of Life questionnaire
Time frame: At the time of inclusion and 12 months after radiosurgery
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University Medical Center Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
University Medical Center Charite Berlin
Berlin, Germany