Ireland
--:--IST
Recruiting Phase 1

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

NCT05594368 · tracked via the Priya Life Science Czechia tracker
Phase
Phase 1
Started
2022-07-01
Last updated
2026-08-21

Condition(s) studied

Ventricular Tachycardia

Investigational drug(s) / intervention(s)

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

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

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (3)

FacilityCityRegionStatus
University Hospital Ostrava Ostrava Czechia Recruiting
University Hospital Zurich Zurich Canton of Zurich Recruiting
Inselspital Bern Bern Switzerland Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05594368 on ClinicalTrials.gov ↗ ← All trials in Czechia