RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: University of Zurich • ClinicalTrials.gov ID: NCT05594368

Registry updated: 2026-08-21

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Description

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.

Interventions

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.

Eligibility criteria

Inclusion Criteria: Patients with structural heart disease, in particular ischemic and non-ischemic cardiomyopathy: Implanted ICD and/or CRT-D. Prior ≥1 failed catheter ablation (with endocardial ± epicardial approach based on the substrate location and the ECG morphology of clinical VTs) procedure to control sustained monomorphic VT using currently recommended mapping and ablation techniques,2 or patients in whom ablation is not feasible. Reasons for lack of epicardial ablation and non-feasibility of catheter ablation must be specified. Sustained VT recurrence after catheter ablation on optimised antiarrhythmic medication. Age ≥18 years. IRB-approved, written informed consent must be provided Exclusion Criteria: Patients with only premature ventricular contractions. Patients with sustained VT/VF who demonstrate: Acute myocardial infarction; Primary electrical disease (channelopathy); Reversible and treatable cause (e.g., drug-induced or intoxication) of VT that can be adequately addressed otherwise; A target that cannot be safely and precisely defined based on stereotactic radiotherapy accuracy requirements (e.g., anatomical interference from OARs, overlapping prior radiation therapy to the thoracic region); Pregnancy or breastfeeding; Inability to provide informed consent.

Conditions

Ventricular Tachycardia

Locations

University Hospital Ostrava — Ostrava, Czechia
University Hospital Zurich — Zurich, Canton of Zurich, Switzerland
Inselspital Bern — Bern, Switzerland

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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