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NCT Number: NCT07445334

Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes

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.

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Key information

Conditions

Premature Ventricular Complexes Arrhythmias, Cardiac Cardiac Complexes, Premature Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Premature Ventricular Beats Premature Ventricular Contraction (PVC) Ventricular Premature Complexes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Proportion of participants with ≥80% reduction in PVC burden

    Time frame: Baseline to 12 weeks after randomisation

    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.

Secondary outcomes

  1. Change in PVC burden

    Time frame: Baseline to 12 weeks after randomisation

    Change in PVC burden measured by ≥24-hour heart rhythm monitoring compared with baseline.

  2. Proportion of participants with ≥99% reduction in PVC burden

    Time frame: Baseline to 12 weeks after randomisation

    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.

  3. ASTA quality-of-life score

    Time frame: Baseline, 6 weeks and 12 weeks after randomisation

    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.

  4. DASS-21 score

    Time frame: Baseline, 6 weeks and 12 weeks after randomisation

    Change in depression, anxiety and stress symptoms as measured by the Depression, Anxiety and Stress Scale - 21 items (DASS-21).

  5. EQ-5D-5L score

    Time frame: Baseline, 6 weeks and 12 weeks after randomisation

    Change in health-related quality of life as measured by the EQ-5D-5L.

  6. Tolerability of medical therapy

    Time frame: From randomisation to 12 weeks

    Assessment of tolerability of medical therapy, including adherence and adverse events.

  7. Tolerability of catheter ablation

    Time frame: From randomisation to 12 weeks

    Assessment of tolerability of catheter ablation, including complications and adverse events.

  8. Health service utilisation

    Time frame: From randomisation to 12 weeks

    Incidence of hospital admissions during trial follow-up.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Western Sydney Local Health District

Other

Registry information

Official study title

Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes (CAAD-PVC): A Randomised Controlled Trial

Acronym: CAAD-PVC

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 3, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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