Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease

NCT06360939 | Recruiting DMC

• 1 other identifier: ETH02659
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Ventricular Tachycardia; Cardiomyopathies; Arrhythmias, Cardiac; Ventricular Arrythmia

Keywords

catheter ablation; stereotactic body radiation therapy; non invasive; radioablation

Outcome Measures

Primary Outcomes (1)

• VT burden

  Change in proportion of patients with a ≥75% reduction in VT burden at 6 months (number of VT episodes in 6 months post treatment compared to the number of VT episodes in the 6 months prior to randomisation excluding a 6-week blanking period after treatment initiation)

  6 months

Secondary Outcomes (13)

• Recurrent sustained VT

  6, 12, 24 and 36 months

• VT storm

  6, 12, 24 and 36 months

• Absolute VT burden

  6, 12, 24 and 36 months

• Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI)

  At all time points up to 36 months

• ICD shocks

  6, 12, 24 and 36 months

Study Arms (2)

Stereotactic body radiation therapy

EXPERIMENTAL

SBRT within 6 weeks of randomisation guided by previous electrophysiology studies, electrocardiograms and cardiac imaging.

Radiation: SBRT

Catheter ablation

ACTIVE COMPARATOR

CA within 6 weeks of randomisation (constituting standard of care for patients with VT and structural heart disease)

Procedure: CA

Interventions

SBRT RADIATION

Delivery of 25Gy in a single dose fraction to target area within 6 weeks of randomization

Stereotactic body radiation therapy

CA PROCEDURE

CA (endocardial and/or epicardial at operator discretion) within 6 weeks of randomization.

Catheter ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Structural heart disease (including ischaemic cardiomyopathy , non-ischaemic cardiomyopathy or congenital heart disease and defined as any one of
• segmental or global decreased ventricular wall motion as defined by TTE, CT or cMRI
• myocardial hypertrophy
• myocardial scar (evidenced by late gadolinium enhancement on cMRI, wall thinning on cardiac CT, low voltage on electrophysiological study or abnormal intracardiac echocardiography)
• Recurrent monomorphic VT which can include
• at least one episode of VT treated by ICD and/or
• sustained VT (lasting \>30s) and/or
• inducible sustained VT on invasive electrophysiological study (EPS) or non-invasive programmed stimulation (NIPS)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Heart Foundation, Australia: collaborator
• Western Sydney Local Health District: lead
• University of Sydney: collaborator

Study Sites (1)

Westmead Hospital

Westmead, Australia

RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular; Cardiomyopathies; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Tachycardia; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Saurabh Kumar, MBBS | PhD

CONTACT

(02)88908140; saurabh.kumar@health.nsw.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: April 11, 2024
• Study Start: November 3, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): December 20, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)