Stereotactic body radiation therapy versus catheter ablation for ventricular tachycardia in structural heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, randomized trial that will enroll about 60 patients with structural heart disease and recurrent monomorphic ventricular tachycardia to compare stereotactic body radiation therapy (SBRT) with standard catheter ablation. The primary outcome is the proportion of patients achieving a ≥75% reduction in VT burden in the six months after treatment, with safety events compared between groups. Participants will be followed for up to three years (minimum one year) to capture VT recurrence, medication use, hospitalizations, mortality, transplantation, ventricular function, and quality-of-life changes. The trial targets higher-risk patients identified by validated scores such as PAINESD ≥9 or an elevated I‑VT risk score.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Structural heart disease (including ischaemic cardiomyopathy , non-ischaemic cardiomyopathy or congenital heart disease and defined as any one of

   1. segmental or global decreased ventricular wall motion as defined by TTE, CT or cMRI
   2. myocardial hypertrophy
   3. myocardial scar (evidenced by late gadolinium enhancement on cMRI, wall thinning on cardiac CT, low voltage on electrophysiological study or abnormal intracardiac echocardiography)
2. Recurrent monomorphic VT which can include

   1. at least one episode of VT treated by ICD and/or
   2. sustained VT (lasting \>30s) and/or
   3. inducible sustained VT on invasive electrophysiological study (EPS) or non-invasive programmed stimulation (NIPS)
3. PAINESD score of ≥9 points and/or at least moderate risk of VT recurrence or death as defined by the I-VT score. Both are validated tools used clinically to identify patient at high risk of VT recurrence and/or mortality after CA.

Exclusion Criteria:

1. Age \< 18 years
2. Life expectancy \< 3 months
3. Catheter ablation deemed futile or with prohibitive risk by cardiac electrophysiologist.
4. Unwilling or unable to provide consent
5. Known cardiac channelopathies (e.g. Catecholaminergic polymorphic ventricular tachycardia (CPVT), long- or short QT syndrome, Brugada syndrome)
6. Contraindications to radiotherapy as deemed by referring physician and/or radiation oncologist
7. Pregnancy or breast feeding

Where it's running

• Westmead Hospital
  Westmead, Australia Recruiting

Study contacts

• Study coordinator: Saurabh Kumar, MBBS | PhD
• Email: saurabh.kumar@health.nsw.gov.au
• Phone: (02)88908140

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.