Premature ventricular complexes (PVCs) are extra, abnormal heart beats arising from the ventricles of the heart and are the most common ventricular arrhythmia. PVCs can be treated with medication or with a procedure called catheter ablation. It is not known which provides a better cure or provides better quality of life. The purpose of this research project is to study the best way to treat PVCs by comparing the use of medication to catheter ablation to assess which approach is better at reducing symptoms and improving quality of life.
Premature ventricular complex burden of at least 10%, as determined by multiday (>24-hour) heart rhythm monitoring
Normal left ventricular ejection fraction
Aged ≥18 years.
Unable or unwilling to provide informed consent or comply with study requirements including study investigations and follow-up, medical adherence, completion of intervention.
Women who are pregnant or breast feeding.
Life expectancy ≤ 12 months.
Ventricular tachycardia (VT) that is inducible lasting 10 seconds or more; spontaneously occurring lasting 30 seconds or more or not hemodynamically tolerated); or 10 or more episodes of non-sustained ventricular tachycardia (defined as more than five sequential beats, lasting no more than 10 seconds) in 24 hours during ambulatory heart rhythm recording.
Parallel
Catheter ablation
Procedure/SurgeryCatheter ablation (CA) of premature ventricular complexes (PVCs) will be performed in standard fashion as approved by international guidelines. CA aims to deliver therapeutic energy to the site of origin of the PVCs, rendering the tissue there incapable of causing the arrhythmia. Ablations will be performed under sedation or GA, guided by electroanatomic mapping and cardiac imaging. End point of CA will be abolition of all PVCs (with and without isoprenaline provocation) with a 30-minute waiting period. Occasionally, patients may experience episodes of PVC quiescence and an absence of PVCs on the day of CA. This can be a result of changes in medication, stress, hormones, electrolytes and can be unpredictable. As at least one PVC occurring during the CA is required to perform a CA, an episode of PVC quiescence on the day of the procedure that inhibits the ablation from taking place will not preclude the patient from having a repeat attempt at the CA.
Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB)
DrugThis arm aims to replicate standard of care for patients with PVCs managed by a non-interventional approach, usually encompassing patients who have symptoms and have not previously been prescribed an AAD or BB, being commenced on an AAD and/or a BB. Choice of AAD/BB will be left to primary physician: If deferred to the trial team, clinical protocol suggests sotalol (which has both AAD and BB properties) 80mg twice daily, or a lower dose if indicated. If sotalol is contraindicated, an alternative BB may be initiated using standard doses (metoprolol, atenolol, bisoprolol). Clinicians may consider alternative AAD if BBs are contraindicated. For example, a dihydropyridine calcium channel blocker (verapamil or diltiazem) may be initiated if patient has concurrent asthma. If coronary artery disease and structural heart disease is ruled out, flecainide (class I anti-arrhythmic agent) may be used. As with clinical practice, AAD/BB can be changed at any time depending on clinical response.
Change in premature ventricular complex burden
Change in premature ventricular complex burden as measured by multiday heart rhythm monitoring at median 3 months.
Premature ventricular complex burden as measured by ≥24-hour heart rhythm monitoring heart at median 6 months.
Overall premature ventricular complex burden as measured by ≥24-hour heart rhythm monitoring heart at median 6 months.
Left ventricular function
Effect of treatment on left ventricular function, (including left ventricular ejection fraction percentage and global longitudinal strain), as assessed by changes in transthoracic echocardiography at baseline and 6 months.
Quality of Life score as measured by the Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA)
Quality of Life score as measured by questionnaire Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA)
Quality of Life score as measured by the 36-Item Short Form Survey Instrument (SF-36) questionnaire
Quality of Life score as measured by the 36-Item Short Form Survey Instrument (SF-36) questionnaire
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