Premature Ventricular ComplexesCAAD-PVCNCT07445334
Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes
A study testing Catheter ablation and Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB) in people with Premature Ventricular Complexes and Premature Ventricular Contraction (PVC), run by Western Sydney Local Health District at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Premature Ventricular Complexes, Premature Ventricular Contraction (PVC), Premature Ventricular Beats
- What is being tested?
- Catheter ablation and Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustralia
- Study dates
- 31 Mar 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sam Turnbull contact
Australia1 site, 1 recruiting
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Saurabh Kumar, MBBS, PhD, +61288908140, saurabh.kumar@health.nsw.gov.au
Timothy Kwan, MBBS, timothy.kwan@sydney.edu.au
About this study
Official title: Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes (CAAD-PVC): A Randomised Controlled Trial
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
- Being tested
- Catheter ablation, Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB)
- Keywords
- PVC, catheter ablation, Premature Ventricular Complexes, anti-arrhythmic medication, beta blocker
- Medical subject headings
- Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 weeks after randomisation
Secondary outcomes (8)
Change in PVC burden
Change in PVC burden measured by ≥24-hour heart rhythm monitoring compared with baseline.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, 6 weeks and 12 weeks after randomisation
Tolerability of medical therapy
Assessment of tolerability of medical therapy, including adherence and adverse events.
Measured: From randomisation to 12 weeks
Tolerability of catheter ablation
Assessment of tolerability of catheter ablation, including complications and adverse events.
Measured: From randomisation to 12 weeks
Health service utilisation
Incidence of hospital admissions during trial follow-up.
Measured: From randomisation to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start31 Mar 2026
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ventricular ComplexesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Sydney Local Health District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saurabh Kumar, Western Sydney Local Health District
- Investigators
- Saurabh Kumar, MBBS, PhD, Principal investigator, Western Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445334
- Sponsor's protocol ID
- 2025/ETH01234
- Acronym
- CAAD-PVC
- Status last verified
- Sep 2026
- First submitted
- 15 Feb 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes (CAAD-PVC): A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07445334
- Acronym / sponsor ID
- CAAD-PVC / 2025/ETH01234
- Conditions
- Premature Ventricular Complexes, Premature Ventricular Contraction (PVC), Premature Ventricular Beats
- Keywords
- PVC, catheter ablation, Premature Ventricular Complexes, anti-arrhythmic medication, beta blocker
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Western Sydney Local Health DistrictUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter ablation | Active comparator | Procedure: Catheter ablationParticipants 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. |
| Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB) | Active comparator | Drug: Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter ablationCatheter 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. | Procedure or surgery | Catheter ablation |
| Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB)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. | Drug | Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB) |
Primary outcome
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.
8 secondary outcomes
Change in PVC burden
Time frame: Baseline to 12 weeks after randomisation
Proportion of participants with ≥99% reduction in PVC burden
Time frame: Baseline to 12 weeks after randomisation
ASTA quality-of-life score
Time frame: Baseline, 6 weeks and 12 weeks after randomisation
DASS-21 score
Time frame: Baseline, 6 weeks and 12 weeks after randomisation
EQ-5D-5L score
Time frame: Baseline, 6 weeks and 12 weeks after randomisation
Tolerability of medical therapy
Time frame: From randomisation to 12 weeks
Tolerability of catheter ablation
Time frame: From randomisation to 12 weeks
Health service utilisation
Time frame: From randomisation to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sam Turnbull contact
Saurabh Kumar, MBBS, PhD principal investigator
Western Sydney Local Health District
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheter ablation and Medical therapy: Anti-arrhythmic drugs (AAD) and/or beta-adrenergic blocking agents (BB) in people with Premature Ventricular Complexes and Premature Ventricular Contraction (PVC), run by Western Sydney Local Health District at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saurabh Kumar, MBBS, PhD (+61288908140, saurabh.kumar@health.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with ≥80% reduction in PVC burden (time frame: Baseline to 12 weeks after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.