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NCT Number: NCT07059208

Atrioventricular Nodal Ablation Versus Pulmonary Vein Isolation - Patient Centred Decisions

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atrioventricular nodal ablation

Procedure

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

pulmonary vein isolation

Procedure

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

Primary outcomes

  1. All cause rehospitalisation

    Time frame: 2 years

    All rehospitalisations for any reason will be included

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Tung, MBBS

CONTACT

[email protected]

+61752020000

Sponsors and collaborators

Lead sponsor

Sunshine Coast Hospital and Health Service

Other

Registry information

Acronym: AVENUE PACE

Important dates

Study start
2025
Primary completion
2029
Study completion
2031
First posted
Jul 10, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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