Atrioventricular Nodal Ablation Versus Pulmonary Vein Isolation - Patient Centred Decisions

NCT07059208 | Not Yet Recruiting

• 1 other identifier: AVENUE PACE
• Study Type: interventional
• Target: 172
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrial Fibrillation (AF)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• All cause rehospitalisation

  All rehospitalisations for any reason will be included

  2 years

Study Arms (2)

Pulmonary vein isolation

ACTIVE COMPARATOR

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

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

Procedure: Atrioventricular nodal ablation

Interventions

Atrioventricular nodal ablation PROCEDURE

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

Pacemaker implant and atrioventricular nodal ablation

Pulmonary vein isolation PROCEDURE

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

Pulmonary vein isolation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunshine Coast Hospital and Health Service: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Matthew Tung, MBBS

CONTACT

+61752020000; matthew.tung@health.qld.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2031
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 1 Oct 2025 to 1 Oct 2035
• Access Criteria: Accessible by contact person listed