None listed
Conditions
Brief 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.
Interventions
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, int
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. Catheter ablation procedures will be performed in the standard fashion, as described in the international guidelines for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death from the American Heart Association/American College of Cardiology/ Heart Rhythm Society and the expert consensus statement on Catheter Ablation of Ventricular Arrhythmias from Heart Rhythm Society/European Heart Rhythm Association/Asia-Pacific Heart Rhythm Society/Latin-America Heart Rhythm Society .Procedures will be performed under conscious sedation or general anaesthesia by a cardiologist trained in electrophysiology procedures and cardiac arrhythmia ablation. Ablation will be guided by a combination of mapping techniques, as per standard practice, and described in the guidelines for catheter ablation for VT. Mapping techniques will incorporate electro-anatomic substrate mapping, pace mapping, entrainment mapping and activation mapping where haemodynamically tolerated. The expected procedure duration will be between 3-6hrs. Post procedure, AAD is stopped if the patient was drug naïve before randomisation. The baseline type and dose of AAD pre-randomisation is continued if the patient was on an AAD pre-randomisation. Repeat ablation procedures, if necessary, are permitted during the 30 days post-randomisation.
Sponsors
Western Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients will be eligible for inclusion if they have: 1. Greater than or equal to 1 prior episode of sustained VT in the prior 6 months; a. Spontaneous VT: greater than or equal to 1 episode of monomorphic VT treated by anti-tachycardia pacing (ATP) and/or internal shock by an ICD; lasting greater than or equal to 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; b. Spontaneous VT: greater than or equal to 1 episode of sustained spontaneous monomorphic VT lasting greater than or equal to 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; c. Inducible VT: with syncope or palpitations – inducible VT defined as sustained monomorphic VT of CL greater than or equal to 200ms lasting for greater than or equal to 10s during a cardiac electrophysiology study (note with 4 extrastimuli with or without provocation with isoprenaline); 2. 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; 3. Aged greater than or equal to 18 years.
Exclusion criteria
Patients will be excluded if they are: 1. Unable or unwilling to provide informed consent or patients physician feels there is not significant equipoise to justify randomisation; 2. Women who are pregnant, breast feeding; 3. Medical illness with an anticipated life expectancy < 3 months; 4. Unable to complete study procedures or unwilling to be followed up; 5. 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; 6. Known channelopathy such as long QT, short QT, Brugada syndrome, catecholaminergic polymorphic VT; 7. Known prior diagnosis of no structural heart disease, or idiopathic ventricular arrhythmia.
Outcome results
None listed