About this trial
The objective of this study is to demonstrate that higher radiation doses are necessary to induce transmural scar formation which is currently assumed to be the underlying mechanism of successful long-term efficacy of VT treatment and therefore dose-escalation will lead to a significantly reduced long-term VT recurrence rate compared to the currently applied single dose of 25 Gy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Dose escalating stereotactic arrhythmia radioablation to treat ventricular tachycardia (VT)
DeviceDose escalating stereotactic arrhythmia radioablation to treat ventricular tachycardia (VT) refractory to conventional antiarrhythmic and catheter ablation-based therapy. First patients will be treated with a dose from 25 Gy prescribed to the 65-90% target volume encompassing isodose escalating to a maximum of 32.5 Gy prescribed to the 65-90% isodose.
Treatment groups
Trial outcomes
Primary outcomes
safety measured by registered radiation associated adverse events up to 90 days
safety measured by registered radiation associated adverse events
Secondary outcomes
Radiation associated serious adverse event (at least grade 4 or 5 according to CTCAE v5)
Sponsors and contacts
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