RABLAP-AF will compare pulmonary vein isolation (PVI) in combination with posterior wall isolation (PWI) for patients with persistent atrial fibrillation (AF).
Ablation for AF has a high success rate for patients with paroxysmal AF, but success rates for persistent AF remain significantly lower. These patients frequently have more advanced disease in their left atrium than those with paroxysmal AF. A common practice is to perform left atrial PWI in addition to PVI in order to reduce AF recurrence. This approach has conflicting evidence behind it and a large scale clinical trial in those with advanced disease is required. The investigators hope to fill this gap with RABLAP-AF. The investigators will randomise patients with advanced atrial disease 1:1 to PVI+PWI or PVI alone. All patients will receive implantable loop recorders two months prior to the ablation procedure in order to accurately assess the effect of PWI and compare arrhythmia burden before and after ablation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Both arms will receive intracardiac catheter ablation procedures as described.
Liverpool Heart & Chest Hospital
Liverpool, United Kingdom
Time to first day with ATA burden of 12 hours or greater
Time to day with atrial tachyarrhythmia burden lasting 12 hours or greater, following a 3 month blanking period post-ablation
Time frame: From 3 months post ablation to 12 months
Time to first day with ATA burden of 24 hours
Time to first day with atrial tachyarrhythmia burden of 24 hours, following a 3 month blanking period post-ablation
Time frame: From 3 months post ablation to 12 months
Time to first day with ATA burden of 60 minutes or greater
Time to first day with atrial tachyarrhythmia burden of 60 minutes or greater, following a 3 month blanking period post-ablation
Time frame: From 3 months post ablation to 12 months
Number of patients with >= 75% reduction in cumulative burden of AF between pre-ablation and months 3-12
AF burden (assessed by loop recorder) will be analysed in the 2 months pre-ablation and compared with the 9 months post-blanking period. This outcome will assess the number of patients who achieve greater than or equal to 75% reduction.
Time frame: 12 months
Reduction in burden of AF between pre-ablation and months 3-12
AF burden (assessed by loop recorder) will be analysed in the 2 months pre-ablation and compared with the 9 months post-blanking period. This outcome will assess the average % reduction in AF burden between these time periods.
Time frame: 12 months
Difference in AFEQT questionnaire between baseline and month 12
Differences in quality of life indicators as measured by the "AF Effect on QualiTy of life survey" (AFEQT) between baseline and 12 month follow-up
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Time frame: 12 months
Difference in EQ5D questionnaire between baseline and month 12
Differences in quality of life indicators as measured by the "EuroQol 5 Dimension survey" (EQ5D) questionnaire between baseline and 12 month follow-up
Time frame: 12 months
Difference in VAS between baseline and month 12
Differences in quality of life indicators as measured by "Visual Analogue Scale" (VAS) between baseline and 12 month follow-up
Time frame: 12 months
Use of antiarrhythmic drugs from month 3 onwards
Number of patients requiring antiarrhythmic drugs following the 3 month blanking period.
Time frame: From 3 months post ablation to 12 months
Use of direct current cardioversion or repeat ablation
Number of patients requiring cardioversion or repeat ablation
Time frame: From 3 months post ablation to 12 months