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

Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease

This trial will test whether a focused radiation treatment (SBRT) can reduce ventricular tachycardia episodes more than standard catheter ablation in people with advanced structural heart disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Western Sydney Local Health District (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Westmead)
• Trial ID: NCT06360939 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with structural heart disease and recurrent monomorphic VT who are at high risk of VT recurrence or complications (for example PAINESD ≥9 or moderate+ I‑VT score) and who are eligible for catheter ablation or SBRT.

Not a fit: People without structural heart disease, those with low-risk or non-sustained VT, or patients with contraindications to radiation or catheter procedures are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, SBRT could offer a less invasive option that more effectively reduces VT episodes and lowers hospitalizations and repeat procedures.

How similar studies have performed: Small case series and the non-randomized ENCORE-VT work have reported promising reductions in VT burden after SBRT, but randomized data remain limited.

Eligibility criteria

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 this trial is running

Westmead

• Westmead Hospital — Westmead, Australia (Recruiting)

Study contacts

• Study coordinator: Saurabh Kumar, MBBS | PhD

Conditions Ventricular Tachycardia; Cardiomyopathies; Arrhythmias, Cardiac; Ventricular Arrythmia; catheter ablation; stereotactic body radiation therapy; non invasive; radioablation