NCT06360939

Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Western Sydney Local Health District · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized clinical trial is to test the efficacy of stereotactic body radiation therapy (SBRT) in treating ventricular tachycardia (VT) in patients with advanced structural heart disease. The main questions it aims to answer are: * What is the efficacy of SBRT compared to catheter ablation (CA) in achieving a ≥ 75% reduction in VT burden at 6 months * What is the comparable safety profile of SBRT vs CA Researchers will compare SBRT and CA (standard of care).

Detailed description

Hypothesis We hypothesise that in an open label randomised controlled trial of patients with advanced structural heart disease and ventricular tachycardia (VT) that stereotactic body radiation therapy (SBRT) will be superior in reducing VT burden compared to standard care comprising of catheter ablation (CA) and routine medical care with acceptable safety and adverse events. Aims This is a trial to examine if in an open label randomised trial of 60 patients with structural heart disease and VT followed for 3 years with a minimum follow up of 1 year of SBRT compared CA results in: 1. An improvement in a primary outcome of proportion of patients with a ≥75% reduction in VT burden in the 6 months following intervention compared to the 6 months intervention 2. Comparable safety profile (serious adverse events \[SAE\] and adverse events of special interest \[AESI\] at 6 months; 3. reduction in secondary endpoints at 6, 12, 24 and 36 months of: any VT recurrence, absolute % reduction in VT burden compared to 6 months pre-treatment, number of anti-arrhythmic drugs (AADs) compared to pre-treatment, cardiovascular hospitalisation, all-cause mortality, cardiac transplantation, combined endpoint of cardiovascular hospitalisation/transplant/mortality, SAE and AESI from treatment, ventricular function abd change of quality of life (QOL) metrics (at 12 months).

Conditions

• Ventricular Tachycardia
• Cardiomyopathies
• Arrhythmias, Cardiac
• Ventricular Arrythmia

Interventions

Type	Name	Description
RADIATION	SBRT	Delivery of 25Gy in a single dose fraction to target area within 6 weeks of randomization
PROCEDURE	CA	CA (endocardial and/or epicardial at operator discretion) within 6 weeks of randomization.

Timeline

• Start date: 2025-11-03
• Primary completion: 2026-06-20
• Completion: 2027-12-20
• First posted: 2024-04-11
• Last updated: 2026-02-18

Locations

1 site across 1 country: Australia