None listed
Conditions
Brief summary
Fast and irregular heart rhythms coming from the bottom chambers of the heart are called ventricular tachycardia (VT). VT is caused by electrical short circuits in the heart, usually as a result of a previous heart attack. 'VT storm' is a medical emergency which occurs when multiple episodes of VT occur within a short period of time. This can be life-threatening because it can stop your heart from pumping enough blood around the body, which may lead to dizziness, fainting or even death. VT can be treated with either anti-arrhythmic drugs (AADs) or catheter ablation. Catheter ablation involves navigating soft wires from the groin into the heart, to find and deliver controlled burns to the short circuits causing the VT, in an attempt to eliminate the VT. We hypothesise that in patients with VT storm, catheter ablation, compared to the current standard of care with AADs, will reduce VT recurrence, mortality, rates of hospitalisation and adverse events.
Interventions
Patients will be expected to have a catheter ablation during their index hospital admission (preferably within 96 hours of presentation)
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 catheter ablation procedure, standard practice will be followed in stabilising the ventricular tachycardia (VT) including intravenous short acting anti-arrhythmic drugs (AADs) and internal or external c
Patients will be expected to have a catheter ablation during their index hospital admission (preferably within 96 hours of presentation) 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 catheter ablation procedure, standard practice will be followed in stabilising the ventricular tachycardia (VT) including intravenous short acting anti-arrhythmic drugs (AADs) and internal or external cardioversion. 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. The procedural endpoints will be elimination of all clinical and inducible ventricular arrhythmias, as is standard practice, published in the aforementioned international guidelines. Repeat ablation procedures, if necessary, are permitted during the 48 hour blanking period after initiation of therapy. 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.
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/are: 1. Age greater than or equal to 18 years; 2. VT storm due to sustained monomorphic VT (MMVT), confirmed on 12-lead ECG or implanted cardiac device which may include an implanted cardioverter defibrillator (ICD), cardiac pacemaker, loop recorder, cardiac resynchronisation therapy device or detected on a Holter monitor or during an exercise stress test; 3. Patients with VT storm defined as incessant VT or 3 or more isolated episodes of VT appropriately treated by their ICD or VT requiring external or pharmacological attempts at reversion to the patient’s baseline rhythm; 4. Informed consent able to be provided to be in the trial
Exclusion criteria
Patients will be excluded if they have/are: 1. 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; 2. Pregnant and/or breastfeeding 3. Unable or unwilling to provide informed consent 4. Unable or unwilling to complete study procedures or attend clinic follow up
Outcome results
None listed