This is a double blinded randomised placebo-controlled trial comparing the effects of catheter ablation (Cryoablation) versus a placebo procedure on atrial fibrillation burden, symptoms and quality of life
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
140
Pulmonary vein isolation with cryoablation
Placebo procedure
Mid and South Essex NHS Foundation Trust / The Essex Cardiothoracic Centre
Basildon, United Kingdom
Eastbourne District General Hospital
Eastbourne, United Kingdom
Conquest Hospital
Saint Leonards-on-Sea, United Kingdom
Atrial fibrillation burden using continuous monitoring
Time frame: 6 months
Time to symptomatic atrial tachyarrhythmia stratified by length of episode
Time frame: 6 months
Time to asymptomatic atrial tachyarrhythmia stratified by length of episode
Time frame: 6 months
Number of atrial arrhythmia ( symptomatic and asymptomatic) episodes stratified by length of episode
Time frame: 6 months
Change in AF specific quality of life score between each group (AF-PROMS)
Time frame: Baseline and 6 months
Change in health related quality of life in each group (36-Item Short Form Survey Instrument )
Time frame: Baseline and 6 months
Comparison of medical treatment ( Antiarrhythmic drug use)
Time frame: 6 months
Comparison of unscheduled use of health care services
Time frame: 6 months
Number of procedure related complications / adverse events
Time frame: 6 months
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