Higher radiation doses for treating recurrent ventricular tachycardia

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

This study is testing if higher doses of targeted radiation can help people with recurrent ventricular tachycardia who haven't had success with other treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Zurich (other)
• Drugs / interventions: radiation
• Locations: 2 sites (Ostrava and 1 other locations)
• Trial ID: NCT05594368 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of dose-escalated stereotactic arrhythmia radioablation in patients with recurrent ventricular tachycardia (VT). The study hypothesizes that higher radiation doses will promote transmural scar formation, which is believed to be crucial for reducing long-term VT recurrence rates. Participants will include those with structural heart disease who have previously failed catheter ablation attempts. The trial will assess the safety and efficacy of this approach compared to the standard single dose of 25 Gy.

Who should consider this trial

Good fit: Ideal candidates are adults with structural heart disease and a history of recurrent VT despite previous ablation attempts.

Not a fit: Patients with only premature ventricular contractions or those with reversible causes of VT may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly lower the recurrence rate of ventricular tachycardia in patients who have not responded to traditional treatments.

How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating a novel exploration in the treatment of recurrent VT.

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.

Where this trial is running

Ostrava and 1 other locations

• University Hospital Ostrava — Ostrava, Czechia (RECRUITING)
• University Hospital Zurich — Zurich, Canton of Zurich, Switzerland (RECRUITING)

Study contacts

• Study coordinator: Nicolaus Andratschke, MD

Conditions: Ventricular Tachycardia