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

Official title

Dose Escalation for Stereotactic Cardiac Radiation Therapy of Recurrent Ventricular Tachyarrhythmia - a Multi Center, Phase II Clinical Trial

Overview

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

• Device 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.

Primary outcome measures

• safety measured by registered radiation associated adverse events up to 90 days [Time frame: up to 90 days]

Secondary outcome measures (1)

• Radiation associated serious adverse event (at least grade 4 or 5 according to CTCAE v5) [Time frame: As assessed at 90 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Czechia · 1 center

• University Hospital Ostrava — Ostrava

Switzerland · 1 center

• University Hospital Zurich — Zurich

Publications

• Kovacs B, Mayinger M, Ehrbar S, Fesslmeier D, Ahmadsei M, Sazgary L, Manka R, Alkadhi H, Ruschitzka F, Duru F, Papachristofilou A, Sticherling C, Blamek S, Golba KS, Guckenberger M, Saguner AM, Andratschke N. Dose escalation for stereotactic arrhythmia radioablation of recurrent ventricular tachyarrhythmia - a phase II clinical trial. Radiat Oncol. 2023 Nov 8;18(1):185. doi: 10.1186/s13014-023-023 PMID 37941012

Identifiers

NCT: NCT05594368 · 2022-00262

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗