This study is designed to compare three different techniques in ablation of paroxysmal atrial fibrillation. Namely, the Medtronic multi-electrode phased radiofrequency ablation system, the Biosense Webster irrigated multi-electrode phased radiofrequency ablation system, and minimally invasive thoracoscopic surgical ablation. The study hypothesis is that surgical and Biosense Webster ablation are non-inferior to Medtronic ablation.
A target of 75 participants will be randomised 1:1:1 to one of the three treatment arms. Each participant will have an implantable loop recorder (ILR) prior to ablation in order to assess AF burden. After ablation, each participant will be followed up for a year. The ILR will be used to assess reduction in AF burden.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Insertion of implantable loop recorder
AF ablation
Eastbourne General Hospital
Eastbourne, E Sussex, United Kingdom
Royal Sussex County Hospital
Brighton, Sussex, United Kingdom
AF burden
Total proportion of time spent in AF as assessed by ILR
Time frame: 12 months after ablation
Time to AF recurrence
Time to recurrence of any AF after ablation
Time frame: Up to one year
Time to first symptomatic AF recurrence
Time to first symptomatic AF recurrence as assessed by ILR.
Time frame: Up to one year
Change in QoL measures
Change in Quality of Life measures assessed by questionnaire.
Time frame: 12 months after ablation
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