Catheter Ablation Versus Anti-arrhythmic Drugs for Ventricular Tachycardia (CAAD-VT)
Heart Disease Structural Disorder, Ventricular Tachycardia, Cardiomyopathy, Dilated
About this trial
This is an interventional treatment trial for Heart Disease Structural Disorder
Eligibility Criteria
Inclusion Criteria:
Patients will be eligible for inclusion if they have:
≥1 prior episode of sustained VT in the prior 6 months;
- Spontaneous VT: ≥1 episode of monomorphic VT treated by anti-tachycardia pacing (ATP) and/or internal shock by an ICD; lasting ≥30 seconds in the absence of intra-cardiac device therapy that could either be self-terminating or require reversion by pharmacological therapy or external cardioversion;
- Spontaneous VT: ≥1 episode of sustained spontaneous monomorphic VT lasting ≥30 seconds documented on Holter, ECG, Loop recorder or other cardiac monitoring device that could either be self-terminating or require reversion by pharmacological therapy or external cardioversion;
- Inducible VT: with syncope or palpitations - inducible VT defined as sustained monomorphic VT of CL ≥200 ms lasting for ≥10 s during a cardiac electrophysiology study (note with 4 extrastimuli with or without provocation with isoprenaline);
- Already a recipient of an implanted cardiac device such as a pacemaker, defibrillator or a cardiac resynchronisation therapy device and/or is indicated to receive one given a new diagnosis of structural heart disease, based on current guideline recommendations;
- Aged ≥18 years.
Exclusion Criteria:
Patients will be excluded if they are:
- Unable or unwilling to provide informed consent or patients physician feels there is not significant equipoise to justify randomisation;
- Women who are pregnant, breast feeding;
- Medical illness with an anticipated life expectancy <3 months;
- Unable to complete study procedures or unwilling to be followed up;
- Have a concomitant illness, physical impairment or mental condition which in the opinion of the study team/ primary care physician could interfere with the conduct of the study including outcome assessments;
- Known channelopathy such as long QT, short QT, Brugada syndrome, catecholaminergic polymorphic VT;
- Known prior diagnosis of no structural heart disease, or idiopathic ventricular arrhythmia.
Sites / Locations
- The Canberra Hospital
- Blacktown HospitalRecruiting
- Royal Prince Alfred HospitalRecruiting
- Nepean HospitalRecruiting
- John Hunter HospitalRecruiting
- Royal North Shore HospitalRecruiting
- Westmead HospitalRecruiting
- The Prince Charles HospitalRecruiting
- Gold Coast University HospitalRecruiting
- Royal Adelaide HospitalRecruiting
- The Alfred HospitalRecruiting
- The Royal Melbourne Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Ablation
Anti-arrhythmic drugs (AAD)
Patients will be expected to have a catheter ablation procedure within 2 weeks post randomisation and no longer than 30 days post randomisation. Medical therapy can be used as a temporising measure before catheter ablation, as is standard of care. If there is breakthrough VT during the period before the clinical procedure, standard practice will be followed in stabilising the ventricular tachycardia (VT) including intravenous short acting anti-arrhythmic drugs (AAD), admission to hospital, internal or external cardioversion. However, preference will be given to scheduling the procedure within 24-48 hours in this situation.
Patients managed with medical therapy alone by their usual medical practitioners. A protocol aligned with standard clinical care/current clinical guidelines will be provided for guidance, the objective being that the control arm replicates what would constitute standard of care for patients with ventricular tachycardia managed with a non-interventional approach.