Dose Escalation for SBRT of Recurrent VT Ventricular Tachyarrhythmia - a Single Center, Phase II Clinical Trial

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Zurich

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Dose escalating stereotactic arrhythmia radioablation to treat ventricular tachycardia (VT)

    Device

    Dose 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

15 Participants
are divided into 1 treatment group
Group A: Dose escalating stereotactic arrhythmia radioablation to treat ventricular tachycardia (VT)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

safety measured by registered radiation associated adverse events up to 90 days

safety measured by registered radiation associated adverse events

Time frame
up to 90 days

Secondary outcomes

1

Radiation associated serious adverse event (at least grade 4 or 5 according to CTCAE v5)

Time frame
As assessed at 90 days

Other outcomes

Sponsors and contacts

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