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

Phase 1

Recruiting

• Conditions: Ventricular Tachycardia
• Interventions: Device: Dose escalating stereotactic arrhythmia radioablation to treat ventricular tachycardia (VT)

• Registration Number: NCT05594368
• Lead Sponsor: University of Zurich

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-10-21
• Study First Submitted QC: 2022-10-21
• Study First Posted: 2022-10-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-03-03
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose escalating stereotactic arrhythmia radioablation to treat ventricular tachycardia (VT)	Dose escalating stereotactic arrhythmia radioablation to treat ventricular tachycardia (VT)	-

Primary Outcome Measures

Name	Time	Method
safety measured by registered radiation associated adverse events up to 90 days	up to 90 days	safety measured by registered radiation associated adverse events

Secondary Outcome Measures

Name	Time	Method
Radiation associated serious adverse event (at least grade 4 or 5 according to CTCAE v5)	As assessed at 90 days

Trial Locations

Locations (2)

University Hospital Ostrava; 🇨🇿 Ostrava, Czech Republic

University Hospital Zurich; 🇨🇭 Zürich, Zurich, Switzerland