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

University of Zurich (UZH)

Status and phase: Enrolling; Phase 1

Conditions: Ventricular Tachycardia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05594368

2022-00262

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

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

Experimental group

Treatment:

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