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

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

Recruiting
18 years and older
All
Phase 1

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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.

Eligibility

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.

Study details
    Ventricular Tachycardia

NCT05594368

University of Zurich

22 February 2024

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