Atrioventricular Nodal Ablation Versus Pulmonary Vein Isolation - Patient Centred Decisions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Atrioventricular nodal ablation, Pulmonary vein isolation.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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
Primary outcome measures
- All cause rehospitalisation [Time frame: 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07059208 · AVENUE PACE