Stereotactic Radioablation as First-Line Therapy for Scar-Related Ventricular Tachycardia

Trial details

Who runs it

Southlake Health

Trial code

NCT07618780

Record updated

1 June 2026

Original description

Ventricular tachycardia (VT) is a dangerous fast heart rhythm originating from scarred areas of the heart muscle, often after a heart attack or in patients with cardiomyopathy. Patients with VT and structural heart disease typically receive an implantable cardioverter-defibrillator (ICD) to prevent sudden death. Despite the ICD, recurrent VT and ICD shocks remain common and are associated with poor quality of life. Current preventive therapies - antiarrhythmic medications and catheter radiofrequency ablation - have important limitations including side effects, incomplete effectiveness, and procedural risk.Read full original descriptionShow less

Stereotactic Arrhythmia Radioablation as First-Line Treatment for Scar-Related Ventricular Tachycardia

Ventricular tachycardia (VT) is a dangerous fast heart rhythm originating from scarred areas of the heart muscle, often after a heart attack or in patients with cardiomyopathy. Patients with VT and structural heart disease typically receive an implantable cardioverter-defibrillator (ICD) to prevent sudden death. Despite the ICD, recurrent VT and ICD shocks remain common and are associated with poor quality of life. Current preventive therapies - antiarrhythmic medications and catheter radiofrequency ablation - have important limitations including side effects, incomplete effectiveness, and procedural risk.

Stereotactic Arrhythmia Radioablation (STAR) is a non-invasive treatment in which a single, precisely targeted dose of radiation is delivered to the scar tissue that gives rise to the abnormal heart rhythm. STAR has previously been studied in patients who have failed catheter ablation or are too high risk for that procedure, with promising results. However, STAR has not been formally evaluated as a first-line treatment.

This single-arm prospective feasibility study will enroll 20 adults with structural heart disease and sustained monomorphic VT. Each participant will receive a single 25 Gy fraction of stereotactic body radiotherapy (VMAT technique) targeted at the arrhythmogenic substrate identified by cardiac imaging, 12-lead ECG, and (where available) non-invasive electrocardiographic mapping or electroanatomical mapping. Participants will be followed at 6 weeks, 3, 6, 9, and 12 months to assess the primary efficacy outcomes (death, appropriate ICD shock, VT storm, and sustained VT below ICD detection rate after a 6-week blanking period) and safety outcomes (acute heart failure decompensation, drop in left ventricular ejection fraction, and STAR-specific toxicities such as pneumonitis, esophagitis, and pericarditis). The hypothesis is that STAR delivered as first-line therapy is safe and effective, with a comparable toxicity and efficacy profile to catheter radiofrequency ablation.

Inclusion: Age 18 years or older and able to provide informed consent; Structural heart disease with myocardial fibrosis identified on pre-procedural imaging, including imaging evidence of regional myocardial akinesis/thinning or documented scar on echocardiography, cardiac CT, or cardiac MRI; Sustained monomorphic ventricular tachycardia (symptomatic or requiring ICD shocks for termination) within the previous 6 months.

Exclusion: Reversible causes of VT (e.g., active ischemia, drug-induced, electrolyte abnormalities); Patients previously treated with high-dose radiotherapy that precludes safe delivery of thoracic stereotactic radiotherapy (relative contraindication); Patients who cannot tolerate the radiotherapy treatment position, or whose body habitus is not permissible by treatment bed requirements; Acute coronary syndrome within 30 days, coronary revascularization (<90 days for bypass surgery, <30 days for percutaneous coronary intervention); Patients requiring chest radiotherapy for an active cancer (relative contraindication); VT targets cannot be identified or are not suitable for targeting with stereotactic radiotherapy (such as multiple foci of arrhythmia); Patients being considered for cardiac transplant who are deemed not eligible by their transplant team for STAR; Pregnant or breast-feeding women.

ClinicalTrials.gov NCT07618780