Atrioventricular Nodal Ablation Versus Pulmonary Vein Isolation - Patient Centred Decisions

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation (AF)

• Registration Number: NCT07059208
• Lead Sponsor: Sunshine Coast Hospital and Health Service

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-07-01
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-14
• Study Start: 2025-09-01
• Primary Completion: 2029-09
• Study Completion: 2031-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 172

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
All cause rehospitalisation	2 years	All rehospitalisations for any reason will be included