Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in

Status Not yet recruiting

Clinical Trial 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).

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06360939
Study type	Interventional
Source	Western Sydney Local Health District
Contact	Saurabh Kumar, MBBS \| PhD
Phone	(02)88908140
Email	saurabh.kumar@health.nsw.gov.au
Status	Not yet recruiting
Phase	N/A
Start date	April 15, 2024
Completion date	April 15, 2027

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease — Radioablate

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms