An interventional study of Catheter ablation and Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB) in Premature Ventricular Complexes, Premature Ventricular Contraction (PVC) and Premature Ventricular Beats, sponsored by Western Sydney Local Health District. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Western Sydney Local Health District · Not applicable, Interventional, and Treatment
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.
102 studies on the registry are indexed under Ventricular Premature Complexes; 32 are open to participants now.
This study's planned enrollment of 50 is below the median of 84 across 58 interventional studies indexed under Ventricular Premature Complexes.
Browse Ventricular Premature Complexes studies →Western Sydney Local Health District is the lead sponsor of 36 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomised to catheter ablation will be expected to undergo catheter ablation for PVCs within 2 weeks after randomisation. Medical therapy may be used as a temporising measure before ablation as standard care. If the participant is drug-naïve, initiation of sotalol is recommended but not mandated. Medical therapy for PVCs should be discontinued after ablation and at least five half-lives before ablation. Repeat ablation procedures will be discouraged during the 12-week monitoring period although if PVC quiescence prevents targeted ablation, one repeat ablation attempt may be undertaken within two weeks. Ablation will be guided by a combination of standard mapping techniques, as per standard practice. Preference will be given to "activation mapping" of the PVCs (which may be stimulated by administration of intravenous isoprenaline) using a three-dimensional electroanatomic mapping system. If there is paucity of PVCs, then "pace-mapping" will be performed.
Procedure: Catheter ablation
Participants randomised to medical therapy will be managed with medical therapy alone by their usual medical practitioners. The objective is to replicate standard care for patients with PVCs managed using a non-interventional approach. The protocol recommends sotalol, starting at 40 mg twice daily and uptitrating to 80 mg twice daily after at least one week as tolerated; minimum total daily dose is 40 mg and maximum total daily dose is 320 mg. If sotalol is contraindicated or not tolerated, metoprolol is recommended, starting at 25 mg twice daily and uptitrating to a maximum total daily dose of 300 mg. Verapamil or diltiazem may be considered when beta blockers are contraindicated; flecainide may be considered if coronary artery disease and structural heart disease have been ruled out. AADs may be changed at any time according to clinical response. Ultimately, the choice of AADs will be left to the treating physician who does not need to follow the above recommendations.
Drug: Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB)
Catheter 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.
This 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.
Time frame: Baseline to 12 weeks after randomisation
Change in PVC burden
Change in PVC burden measured by ≥24-hour heart rhythm monitoring compared with baseline.
Time frame: Baseline to 12 weeks after randomisation
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.
Time frame: Baseline to 12 weeks after randomisation
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.
Time frame: Baseline, 6 weeks and 12 weeks after randomisation
DASS-21 score
Change in depression, anxiety and stress symptoms as measured by the Depression, Anxiety and Stress Scale - 21 items (DASS-21).
Time frame: Baseline, 6 weeks and 12 weeks after randomisation
EQ-5D-5L score
Change in health-related quality of life as measured by the EQ-5D-5L.
Time frame: Baseline, 6 weeks and 12 weeks after randomisation
Tolerability of medical therapy
Assessment of tolerability of medical therapy, including adherence and adverse events.
Time frame: From randomisation to 12 weeks
Tolerability of catheter ablation
Assessment of tolerability of catheter ablation, including complications and adverse events.
Time frame: From randomisation to 12 weeks
Health service utilisation
Incidence of hospital admissions during trial follow-up.
Time frame: From randomisation to 12 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
Started Mar 2026 (actual). Primary completion is estimated for Sep 2027, 17 months after the start.
Of 32 interventional studies with no phase under Ventricular Premature Complexes, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 52. This study's planned 17 months is close to that.
How these figures are worked out, and which studies are left out of them.
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Western Sydney Local Health District