Comparison of (i) catheter ablation, (ii) electrical cardioversion and (iii) pacemaker implantation with AV node ablation for patients over 65 years of age with persistent Atrial Fibrillation.
the National Institute for Health and Care Excellence (NICE) suggest the following treatments options can be considered for patients with recurrent persistent atrial fibrillation: 1. Direct current cardioversion (DCCV) with concomitant anti-arrhythmic treatment. 2. Permanent pacemaker implantation (PPM) and atrio-ventricular (AV) node ablation. 3. Left atrial catheter ablation. These treatment options have not been directly compared and each has their own advantages and disadvantages. 1. DC cardioversion is highly successful at restoring sinus rhythm and is a relatively cheap intervention. There is however a high recurrence rate of AF and cardioversion may need to be repeated multiple times. 2. Permanent pacemaker implantation and AV node ablation, 'ablate and pace' therapy provides rapid relief of symptoms and improved quality of life. Patients remain in atrial fibrillation but have a regular heart rhythm and controlled rate and avoid potential side-effects of medications. Following AV node ablation patients are dependent on the pacemaker and as such this treatment option is usually reserved for those over 65 years or age. Costs are modest and both the pacemaker insertion and AV node ablation procedures take less than 1 hour to perform. 3. Catheter ablation for atrial fibrillation aims to restore and sustain sinus rhythm. Procedural success rates are 50-60% after a single procedure and 80-85% after repeat procedures and it can take several months for all procedures in an ablation strategy to be performed. Procedural costs are high due to the equipment used and time taken for each ablation, usually 1.5-4 hours.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Left atrial ablation of persistent atrial fibrillation and implantable loop recorder insertion.
Permanent pacemaker implant followed by AV node ablation
Electrical cardioversion for Persistent Atrial Fibrillation and implantable loop recorder insertion.
Eastbourne District General Hospital
Eastbourne, East Sussex, United Kingdom
Conquest Hospital
Saint Leonards-on-Sea, East Sussex, United Kingdom
AF recurrence
Time to recurrence of persistent AF
Time frame: 12 months
Patient experience of procedure
Patient experience of each procedure will be assessed by validated questionnaires
Time frame: Baseline
Total costs of the treatment options
Time frame: 12 months
AF recurrence >2minutes
Time to recurrence of AF episode \> 2 minutes
Time frame: 12 months
Symptoms / QOL
To assess differences in symptoms and QOL
Time frame: 12 months
Exercise performance
To measure the three treatment effects on VO2 max over time by means of cardiopulmonary exercise testing.
Time frame: 12 months
AF burden
To measure the three treatment effects on AF burden
Time frame: 12 months
Sleep apnoea
To assess the impact of the three treatment options on sleep apnoea scores
Time frame: 6 months
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