Key result
Ongoing CORNERSTONE AF trial evaluates adjunctive posterior wall isolation for preventing atrial arrhythmias.
Why the study?
It was hypothesized that adjunctive empirical left atrial posterior wall isolation would increase freedom from recurrent atrial arrhythmias compared with standard AF ablation in persistent AF patients.
Does adjunctive left atrial posterior wall isolation (LAPWI) improve freedom from recurrent atrial arrhythmias compared to standard pulmonary vein isolation (PVI) in patients with persistent atrial fibrillation?
RCT (n=516)
1:1
Yes
Does adjunctive left atrial posterior wall isolation (LAPWI) improve freedom from recurrent atrial arrhythmias compared to standard pulmonary vein isolation (PVI) in patients with persistent atrial fibrillation?
The CORNERSTONE AF trial will determine whether adding empirical left atrial posterior wall isolation to standard pulmonary vein isolation improves 18-month freedom from atrial arrhythmias in patients with persistent atrial fibrillation.
BACKGROUND: A left atrial posterior wall isolation (LAPWI) is one of the atrial fibrillation (AF) ablation strategies. HYPOTHESIS: We hypothesized that an additional empirical LAPWI would increase the freedom from recurrent atrial arrhythmias as compared to standard AF ablation in persistent AF patients. METHODS: The CORNERSTONE AF study is a prospective, randomized, multicenter study investigating patients with AF persisting for >7 days and <3 years undergoing first-time AF ablation. They will be randomized to pulmonary vein isolation (PVI) or PVI + LAPWI in a 1:1 manner. Although PVI can be performed with either radiofrequency catheters or cryoballoons, only radiofrequency catheters will be permitted to achieve LAPWIs. Additional focal ablation targeting non-pulmonary vein triggers will be allowed. A total of 516 patients will be enrolled in 17 centers between August 2022 and February 2024 based on the calculation with 80% power, considering the assumption that 65% and 75% of the PVI and PVI + LAPWI group patients will be free from atrial arrhythmia recurrence 18-months postprocedure (10% of dropout). The primary endpoint is freedom from documented atrial arrhythmias 18 months postsingle procedures. Clinical follow-up will include 7-day ambulatory electrocardiograms and routine outpatient consultations by electrophysiologists at 1, 3, 6, 9, 12, and 18 months postprocedure. RESULTS: As of August 2023, a total of 331 patients (68 ± 9 years, 270 men, 43 longstanding persistent AF) have been enrolled. CONCLUSIONS: The CORNERSTONE AF study is a prospective, randomized, multicenter trial designed to evaluate the efficacy and safety of an adjunctive empirical LAPWI following standard AF ablation in persistent AF patients.
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Shigeta et al. (2023) conducted an RCT in Persistent and longstanding persistent atrial fibrillation (n=516). Pulmonary vein isolation + left atrial posterior wall isolation (PVI + LAPWI) vs. Pulmonary vein isolation (PVI) alone was evaluated on Freedom from documented atrial arrhythmias 18 months postsingle procedures. Adjunctive left atrial posterior wall isolation following standard ablation is being evaluated in the ongoing CORNERSTONE AF trial of 516 patients for freedom from atrial arrhythmias at 18 months.
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