Atrial Fibrillation (AF)AVENUE PACENCT07059208
Atrioventricular Nodal Ablation Versus Pulmonary Vein Isolation - Patient Centred Decisions
A study testing Atrioventricular nodal ablation and Pulmonary vein isolation in people with Atrial Fibrillation (AF), run by Sunshine Coast Hospital and Health Service.
Trial summary
The goal of this clinical trial is to compare two procedural approaches to managing atrial fibrillation. The main questions it aims to answer are: Is AF ablation or pacemaker implant and AV nodal ablation a more effective treatment approach for patients with atrial fibrillation refractory to pharmacological treatment?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Atrioventricular nodal ablation and Pulmonary vein isolation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Sep 2031
- 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
- Age greater than 65 years for patients with persistent atrial fibrillation or greater than 75 years for patients with paroxysmal atrial fibrillation.
- Unsuccessful trial of at least one pharmacological rate or rhythm control medication. This includes patients with medication refractory AF and/or intolerance to the medication(s).
- A resting ECG demonstrating AF with ventricular response rate >70bpm on a pharmacological rate control medication, or >90bpm while not on rate control medication.
Who cannot join
- Previous pulmomary vein isolation, left atrial flutter ablation or atrioventricular node ablation.
- BMI >40.
- Not suitable for pulmonary vein isolation and/or pacemaker implant on clinical grounds.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to compare two procedural approaches to managing atrial fibrillation. The main questions it aims to answer are:
Is AF ablation or pacemaker implant and AV nodal ablation a more effective treatment approach for patients with atrial fibrillation refractory to pharmacological treatment?
What effect do these differing treatment approaches have on patient's quality of life and mental health?
Participants will:
Be randomly allocated to one of the treatment approaches. Visit the clinic 2 months, 12 months and 24 months after their procedure for a checkup, questionnaires and repeat heart ultrasounds.
Read the detailed description
The goal of this trial is to compare the effectiveness and safety of pulmonary vein isolation compared with pacemaker implant and atrioventricular nodal ablation for patients with atrial fibrillation.
Patients who have been refractory to attempts at symptom control with pharmacological therapy will be eligible and will be randomised to one of the two approaches.
The primary outcome will be all cause rehospitalisation with secondary outcomes including procedural complications, echocardiographic measurements, patient reported outcomes, all cause mortality and rehospitalisation due to cardiovascular causes. These will be assessed over the 2 years following the index procedure.
The patient reported outcome measures will be the EQ5D, AF Effect on Quality of life score (AFEQT), Hospital anxiety and depression score (HADS) and Somatosensory amplification scale.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Atrioventricular nodal ablation, Pulmonary vein isolation
- Keywords
- atrial fibrillation ablation, Pulmonary vein isolation, Physiological pacing, atrioventricular nodal ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrioventricular nodal ablationProcedure or surgery
Patients randomised to this arm would undergo physiological pacing followed by atrioventricular nodal ablation
Pulmonary vein isolationProcedure or surgery
Patients randomised to this arm would undergo catheter ablation targeted at achieving pulmonary vein isolation
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary vein isolation | Active comparator | Patients randomised to this arm would undergo catheter ablation targeted at achieving pulmonary vein isolation Receives: Procedure: Pulmonary vein isolation |
| Pacemaker implant and atrioventricular nodal ablation | Active comparator | Patients randomised to this arm would undergo physiological pacing followed by atrioventricular nodal ablation Receives: Procedure: Atrioventricular nodal ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause rehospitalisation
All rehospitalisations for any reason will be included
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunshine Coast Hospital and Health Service
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Tung, Sunshine Coast Hospital and Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059208
- Sponsor's protocol ID
- AVENUE PACE
- Acronym
- AVENUE PACE
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All deidentified data will be shared with any potential research collaborators
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrioventricular Nodal Ablation Versus Pulmonary Vein Isolation - Patient Centred Decisions
- ClinicalTrials.gov ID
- NCT07059208
- Acronym / sponsor ID
- AVENUE PACE / AVENUE PACE
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- atrial fibrillation ablation, Pulmonary vein isolation, Physiological pacing, atrioventricular nodal ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Sunshine Coast Hospital and Health ServiceUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 10 Jul 2025 (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.
The goal of this clinical trial is to compare two procedural approaches to managing atrial fibrillation. The main questions it aims to answer are:
Is AF ablation or pacemaker implant and AV nodal ablation a more effective treatment approach for patients with atrial fibrillation refractory to pharmacological treatment?
What effect do these differing treatment approaches have on patient's quality of life and mental health?
Participants will:
Be randomly allocated to one of the treatment approaches. Visit the clinic 2 months, 12 months and 24 months after their procedure for a checkup, questionnaires and repeat heart ultrasounds.
Detailed description
The goal of this trial is to compare the effectiveness and safety of pulmonary vein isolation compared with pacemaker implant and atrioventricular nodal ablation for patients with atrial fibrillation.
Patients who have been refractory to attempts at symptom control with pharmacological therapy will be eligible and will be randomised to one of the two approaches.
The primary outcome will be all cause rehospitalisation with secondary outcomes including procedural complications, echocardiographic measurements, patient reported outcomes, all cause mortality and rehospitalisation due to cardiovascular causes. These will be assessed over the 2 years following the index procedure.
The patient reported outcome measures will be the EQ5D, AF Effect on Quality of life score (AFEQT), Hospital anxiety and depression score (HADS) and Somatosensory amplification scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary vein isolation | Active comparator | Procedure: Pulmonary vein isolationPatients randomised to this arm would undergo catheter ablation targeted at achieving pulmonary vein isolation |
| Pacemaker implant and atrioventricular nodal ablation | Active comparator | Procedure: Atrioventricular nodal ablationPatients randomised to this arm would undergo physiological pacing followed by atrioventricular nodal ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than 65 years for patients with persistent atrial fibrillation or greater than 75 years for patients with paroxysmal atrial fibrillation.
- Unsuccessful trial of at least one pharmacological rate or rhythm control medication. This includes patients with medication refractory AF and/or intolerance to the medication(s).
- A resting ECG demonstrating AF with ventricular response rate >70bpm on a pharmacological rate control medication, or >90bpm while not on rate control medication.
Key exclusion criteria (3 listed)
- Previous pulmomary vein isolation, left atrial flutter ablation or atrioventricular node ablation.
- BMI >40.
- Not suitable for pulmonary vein isolation and/or pacemaker implant on clinical grounds.
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 |
|---|---|---|
| Atrioventricular nodal ablationPatients randomised to this arm would undergo physiological pacing followed by atrioventricular nodal ablation | Procedure or surgery | Pacemaker implant and atrioventricular nodal ablation |
| Pulmonary vein isolationPatients randomised to this arm would undergo catheter ablation targeted at achieving pulmonary vein isolation | Procedure or surgery | Pulmonary vein isolation |
Primary outcome
All cause rehospitalisation
Time frame: 2 years
All rehospitalisations for any reason will be included
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 14 Jul 2025.
- Individual participant dataSharing planned: Yes. All deidentified data will be shared with any potential research collaborators
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Atrioventricular nodal ablation and Pulmonary vein isolation in people with Atrial Fibrillation (AF), run by Sunshine Coast Hospital and Health Service.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Matthew Tung, MBBS (+61752020000, matthew.tung@health.qld.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause rehospitalisation (time frame: 2 years). 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 14 Jul 2025.