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.
PVC burden of ≥10% as determined by ≥24-hour heart rhythm monitoring.
Normal left ventricular ejection fraction, defined as ejection fraction ≥50%.
Aged ≥18 years.
Symptoms due to PVCs according to the judgement of the treating physician.
Unable or unwilling to provide informed consent or comply with study requirements including study investigations, follow-up, medical adherence and completion of the assigned intervention.
Women who are pregnant or breastfeeding.
Life expectancy ≤12 months.
Ventricular tachycardia (VT), defined as spontaneous VT lasting ≥30 seconds, haemodynamically unstable VT of any duration, inducible sustained VT during any electrophysiology study, or ≥10 episodes of non-sustained VT (>5 consecutive beats lasting ≤30 seconds) within 24 hours on heart rhythm monitoring.
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.
Proportion of participants with ≥80% reduction in PVC burden
Number of participants achieving at least an 80% reduction in PVC burden, measured by ≥24-hour heart rhythm monitoring and compared with baseline PVC burden.
Change in PVC burden
Change in PVC burden measured by ≥24-hour heart rhythm monitoring compared with baseline.
Proportion of participants with ≥99% reduction in PVC burden
Number of participants achieving at least a 99% reduction in PVC burden, measured by ≥24-hour heart rhythm monitoring and compared with baseline PVC burden.
ASTA quality-of-life score
Change in quality of life as measured by the Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA). The ASTA is the primary quality-of-life measure.
DASS-21 score
Change in depression, anxiety and stress symptoms as measured by the Depression, Anxiety and Stress Scale - 21 items (DASS-21).
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