Catheter Ablation Versus Anti-arrhythmic Drugs for Ventricular Tachycardia
Status:
Recruiting
Trial end date:
2026-06-30
Target enrollment:
Participant gender:
Summary
Sudden cardiac death (SCD) due to recurrent ventricular tachycardia (VT) is an important
clinical sequela in patients with structural heart disease. VT generally occurs as a result
of electrical re-entry in the presence of arrhythmogenic substrate (scar). Scar tissue forms
due to an ischemic cardiomyopathy (ICM) from prior coronary obstructive disease or a
non-ischemic cardiomyopathy (NICM) from an inflammatory or genetic disease.
AADs can reduce VT recurrence, but have significant limitations in treatment of VT. For
example, amiodarone has high rates of side effects/toxicities and a finite effective usage
before recurrence. ICDs prevent cardiac arrest and sudden death from VT, but do not stop VT
occurring. Recurrent VT and ICD therapies decrease QOL, increase hospital visits, mortality,
morbidity and risk of death. Improvement in techniques for mapping and ablation of VT have
made CA an alternative.
Currently, there is limited evidence to guide clinicians either toward AAD therapy or CA in
patients with NICM. This data shows significant benefit of CA over medical therapy in terms
of VT free survival, survival free of VT storm and VT burden. Observational studies suggest
that CA is effective in eliminating VT in NICM patients who have failed AADs, resulting in
reduction of VT burden and AAD use over long term follow up. Furthermore, there is limited
data on the efficacy of CA in early ICM with VT, or advanced ICM with VT. RCT data is almost
exclusively on patients with modest ICM with VT, and this is not representative of the
real-world scenario of patients with structural heart disease presenting with VT.
Therefore the primary objective is to determine in all patients with structural heart disease
and spontaneous or inducible VT, if catheter ablation compared to standard medical therapy
with anti-arrhythmic drugs results in a reduction of a composite endpoint of recurrent VT, VT
storm and death at a median follow up of 18 months.