The purpose of this study is 3 fold:- 1. To compare the efficacy and complication rates of 2 widely used methods, conventional irrigation tip ablation catheter (LASSO) and Ablation Frontiers ablation technology, of AF ablation for PAF. 2. To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared to the 'gold standard' DDD pacemaker Holter. 3. To accurately evaluate, by continuous rhythm monitoring for 1 year, the efficacy of AF ablation therapy for PAF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
AF Ablation with Ablation Frontiers Technology - PVAC, TVAC and MASC.
AF Ablation with traditional LASSO catheter
Reveal XT implantable loop recorder monitored group
Eastbourne District General Hospital
Eastbourne, East Sussex, United Kingdom
AF Burden
AF Burden post left atrial ablation is defined as the sum of the duration of all atrial tachyarrhythmias expressed as a percentage of the total observation period as assessed by PM Holters.
Time frame: 12 Months
AF Burden
Comparison of AF burden post PVI ablation using a conventional irrigation tip catheter with LASSO guidance (or equivalent) versus Ablation Frontiers Technology using the PVAC, MASC and TVAC catheters via standard trans-septal techniques.
Time frame: 12 months
AF Burden detected
To evaluate the Reveal XT ILR as a long term accurate AF monitoring device as compared to the 'gold standard' DDD pacemaker Holter.
Time frame: 12 months
Arrhythmia frequency - symptomatic or asymptomatic.
Arrhythmia Frequency is defined as the total number of atrial tachyarrhythmic episodes divided by the observation period, expressed as episodes per day as assessed by PM Holters.
Time frame: 12 months
Time to first episode of AF
Time to persistent AF is defined as the time from ablation to the first recorded episode of AF
Time frame: 12 months
Average AF duration
Average arrhythmia duration is defined as the total duration of atrial arrhythmia divided by the total number of atrial arrhythmia episodes.
Time frame: 12 months
Time to persistent AF.
Time to persistent AF (atrial fibrillation episode lasting for 7 days)
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This group will be monitored with a dual chamber pacemaker with advanced AF monitoring capabilities.
Time frame: 12 months
Average SR duration.
Average sinus rhythm duration is defined as the total duration of sinus rhythm from first atrial arrhythmic episode until last atrial arrhythmic episode divided by the number of atrial arrhythmic episodes minus 1.
Time frame: 12 months