Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWestern Sydney Local Health District
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Age < 18 years
Life expectancy < 3 months
Catheter ablation deemed futile or with prohibitive risk by cardiac electrophysiologist.
Unwilling or unable to provide consent
Trial design
Design model
Parallel
Treatments tested in this trial
SBRT
RadiationDelivery of 25Gy in a single dose fraction to target area within 6 weeks of randomization
CA
Procedure/SurgeryCA (endocardial and/or epicardial at operator discretion) within 6 weeks of randomization.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Stereotactic body radiation therapyExperimental treatment 1 intervention
Group B: Catheter ablationActive comparator 1 intervention
Trial outcomes
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)
Time frame
6 monthsSecondary outcomes
1
Recurrent sustained VT
Recurrent sustained VT ascertained by implanted cardioverter defibrillator (ICD) (VT identified and treated by the ICD with anti-tachycardia pacing (ATP) and/or internal ICD delivered shock or ≥30 seconds of VT if untreated by ICD
Time frame
6, 12, 24 and 36 months2
VT storm
VT storm (three or more documented episodes of VT within 24 hours or incessant VT)
Time frame
6, 12, 24 and 36 months3
Absolute VT burden
Absolute percentage reduction in VT burden compared to pre-ablation
Time frame
6, 12, 24 and 36 months4
Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI)
1. SAE and AESI related to effects of SBRT 2. SAE and AESI related to standard care e.g. medical anti-arrhythmic drug therapy or catheter ablation or heart transplantation
Time frame
At all time points up to 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Western Sydney Local Health District
Lead sponsor
University of Sydney
Collaborator
National Heart Foundation, Australia
Collaborator
Source ClinicalTrials.gov