The efficacy and safety of left atrial low‐voltage area guided ablation for recurrence prevention compared to pulmonary vein isolation alone in patients with persistent atrial fibrillation trial: Design and rationale
Akihiro Sunaga, Masaharu Masuda, Koichi Inoue, Nobuaki Tanaka, Tetsuya Watanabe, Yoshio Furukawa, Yasuyuki Egami, Akio Hirata, Nobuhiko Makino, Hitoshi Minamiguchi, Takafumi Oka, Tomoko Minamisaka, Toshihiro Takeda, Tomomi Yamada, Tetsuhisa Kitamura, Hirota Kida, Bolrathanak Oeun, Taiki Sato, Yohei Sotomi, Tomoharu Dohi, Katsuki Okada, Shinichiro Suna, Hiroya Mizuno, Daisaku Nakatani, Shungo Hikoso, Yasushi Sakata, OCVC‐SUPPRESS‐AF investigators
Abstract
Recurrence rates of atrial fibrillation (AF) after pulmonary vein isolation (PVI) are higher in patients with a left atrial low-voltage area (LVA) than those without. However, the efficacy of LVA guided ablation is still unknown. The purpose of this study-the Efficacy and Safety of Left Atrial Low-voltage Area Guided Ablation for Recurrence Prevention Compared to Pulmonary Vein Isolation Alone in Patients with Persistent Atrial Fibrillation trial (SUPPRESS-AF trial)-is to elucidate whether LVA guided ablation in addition to PVI is superior to PVI alone in patients with persistent AF. The Osaka Cardiovascular Conference will conduct a multicenter, randomized, open-label trial aiming to examine whether LVA guided ablation in addition to PVI is superior to PVI alone in patients with persistent AF and LVAs. The primary outcome is the recurrence of AF documented by scheduled or symptom-driven electrocardiography (ECG) during the 1 year follow-up period after the index ablation. The key secondary endpoints include all-cause death, symptomatic stroke, bleeding events, and other complications related to the procedure. A total of 340 patients with an LVA will be enrolled and followed up to 1 year. The SUPPRESS-AF trial is a randomized controlled trial designed to assess whether LVA guided ablation in addition to PVI is superior to PVI alone for patients with persistent AF and LVAs detected while undergoing their first catheter ablation.