%0 Clinical Trial Protocol
%T Adjunctive posterior wall isolation for the treatment of persistent and longstanding persistent atrial fibrillation (CORNERSTONE AF) trial: Design and rationale.
%A Shigeta T
%A Miyazaki S
%A Inaba O
%A Inamura Y
%A Nitta J
%A Sekiguchi Y
%A Takahashi A
%A Hachiya H
%A Nagata Y
%A Yamauchi Y
%A Hayashi T
%A Iwai S
%A Mizukami A
%A Ono Y
%A Handa K
%A Suzuki M
%A Suzuki A
%A Nakajima J
%A Hirao K
%A Okada H
%A Negishi M
%A Ikenouchi T
%A Yamamoto T
%A Goto K
%A Nishimura T
%A Tao S
%A Takigawa M
%A Hirakawa A
%A Goya M
%A Sasano T
%J Clin Cardiol
%V 47
%N 1
%D 2024 Jan 11
%M 37822107
%F 3.287
%R 10.1002/clc.24164
%X <B>BACKGROUND: </B>A left atrial posterior wall isolation (LAPWI) is one of the atrial fibrillation (AF) ablation strategies.<BR><B>OBJECTIVE: </B>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.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>As of August 2023, a total of 331 patients (68 ± 9 years, 270 men, 43 longstanding persistent AF) have been enrolled.<BR><B>CONCLUSIONS: </B>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.