Atrioventricular Nodal Ablation Versus Pulmonary Vein Isolation - Patient Centred Decisions
NCT ID: NCT07059208
Last Updated: 2025-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
172 participants
INTERVENTIONAL
2025-09-30
2031-09-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pulmonary vein isolation
Patients randomised to this arm would undergo catheter ablation targeted at achieving pulmonary vein isolation
Pulmonary vein isolation
Patients randomised to this arm would undergo catheter ablation targeted at achieving pulmonary vein isolation
Pacemaker implant and atrioventricular nodal ablation
Patients randomised to this arm would undergo physiological pacing followed by atrioventricular nodal ablation
Atrioventricular nodal ablation
Patients randomised to this arm would undergo physiological pacing followed by atrioventricular nodal ablation
Interventions
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Atrioventricular nodal ablation
Patients randomised to this arm would undergo physiological pacing followed by atrioventricular nodal ablation
Pulmonary vein isolation
Patients randomised to this arm would undergo catheter ablation targeted at achieving pulmonary vein isolation
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* BMI \>40.
* Not suitable for pulmonary vein isolation and/or pacemaker implant on clinical grounds.
18 Years
ALL
No
Sponsors
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Sunshine Coast Hospital and Health Service
OTHER
Responsible Party
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Matthew Tung
Principal Investigator
Central Contacts
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Other Identifiers
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AVENUE PACE
Identifier Type: -
Identifier Source: org_study_id
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