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Atrioventricular Nodal Ablation Versus Pulmonary Vein Isolation - Patient Centred Decisions

Atrioventricular Nodal Ablation Versus Pulmonary Vein Isolation - Patient Centred Decisions

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07059208
Acronym
AVENUE PACE
Enrollment
172
Registered
2025-07-10
Start date
2025-09-30
Completion date
2031-09-30
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF)

Keywords

atrial fibrillation ablation, Pulmonary vein isolation, Physiological pacing, atrioventricular nodal ablation

Brief 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? 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.

Interventions

Patients randomised to this arm would undergo physiological pacing followed by atrioventricular nodal ablation

PROCEDUREPulmonary vein isolation

Patients randomised to this arm would undergo catheter ablation targeted at achieving pulmonary vein isolation

Sponsors

Sunshine Coast Hospital and Health Service
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
All cause rehospitalisation2 yearsAll rehospitalisations for any reason will be included

Contacts

Primary ContactMatthew Tung, MBBS
matthew.tung@health.qld.gov.au+61752020000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026