NCT07059208

Atrioventricular Nodal Ablation Versus Pulmonary Vein Isolation - Patient Centred Decisions

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: Sunshine Coast Hospital and Health Service · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
PROCEDURE	Atrioventricular nodal ablation	Patients randomised to this arm would undergo physiological pacing followed by atrioventricular nodal ablation
PROCEDURE	Pulmonary vein isolation	Patients randomised to this arm would undergo catheter ablation targeted at achieving pulmonary vein isolation

Timeline

• Start date: 2025-09-01
• Primary completion: 2029-09-01
• Completion: 2031-09-01
• First posted: 2025-07-10
• Last updated: 2025-07-14