Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes

NCT07445334 | Recruiting

• 1 other identifier: 2025/ETH01234
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premature Ventricular Complexes; Premature Ventricular Contraction (PVC); Premature Ventricular Beats

Keywords

PVC; catheter ablation; Premature Ventricular Complexes; anti-arrhythmic medication; beta blocker

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 12 weeks after randomisation

Secondary Outcomes (8)

• Change in PVC burden

  Baseline to 12 weeks after randomisation

• Proportion of participants with ≥99% reduction in PVC burden

  Baseline to 12 weeks after randomisation

• ASTA quality-of-life score

  Baseline, 6 weeks and 12 weeks after randomisation

• DASS-21 score

  Baseline, 6 weeks and 12 weeks after randomisation

• EQ-5D-5L score

  Baseline, 6 weeks and 12 weeks after randomisation

Study Arms (2)

Catheter ablation

ACTIVE COMPARATOR

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

Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB)

ACTIVE COMPARATOR

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)

Interventions

Catheter ablation PROCEDURE

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.

Catheter ablation

Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB) DRUG

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.

Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Previous catheter ablation for ventricular arrhythmia.
• Clinically significant coronary artery disease, defined as a history of myocardial infarction, prior coronary revascularisation, inducible ischaemia on functional testing or obstructive coronary artery disease on coronary imaging. Any type of coronary assessment is permitted, although computed tomography coronary angiography is encouraged.
• Moderate or greater valvular heart disease.
• Known non-ischaemic or ischaemic cardiomyopathy or evidence of myocardial scar on cardiac magnetic resonance imaging suggestive of structural heart disease.
• Known cardiac channelopathies including catecholaminergic polymorphic ventricular tachycardia (CPVT), Brugada syndrome and long- or short-QT syndrome.
• In the opinion of the investigator or responsible physician, participation would not be in the patient's best interest or the patient would be unable to complete study procedures because of concomitant illness, physical impairment or mental condition.

Sponsors & Collaborators

• Western Sydney Local Health District: lead

Study Sites (1)

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

MeSH Terms

Conditions

Ventricular Premature Complexes

Interventions

Catheter Ablation; Adrenergic beta-Antagonists

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Saurabh Kumar, MBBS, PhD

  Western Sydney Local Health District

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saurabh Kumar, MBBS, PhD

CONTACT

+61288908140; saurabh.kumar@health.nsw.gov.au

Sam Turnbull

CONTACT

samual.turnbull@health.nsw.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization will be performed using a secure, password-protected web portal (REDCap) and the allocation sequence will be blinded to investigators and participants until the participants have been deemed eligible and enrolled in the study. It will not be possible to maintain blinding after study enrollment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 15, 2026
• First Posted: March 3, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

AU (1)