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Adjunctive posterior wall isolation for the treatment of persistent and longstanding persistent atrial fibrillation (CORNERSTONE AF) trial: Design and rationale.
Shigeta, Takatoshi; Miyazaki, Shinsuke; Inaba, Osamu; Inamura, Yukihiro; Nitta, Junichi; Sekiguchi, Yukio; Takahashi, Atsushi; Hachiya, Hitoshi; Nagata, Yasutoshi; Yamauchi, Yasuteru; Hayashi, Tatsuya; Iwai, Shinsuke; Mizukami, Akira; Ono, Yuichi; Handa, Keita; Suzuki, Makoto; Suzuki, Atsushi; Nakajima, Jun; Hirao, Kenzo; Okada, Hiroyuki; Negishi, Miho; Ikenouchi, Takashi; Yamamoto, Tasuku; Goto, Kentaro; Nishimura, Takuro; Tao, Susumu; Takigawa, Masateru; Hirakawa, Akihiro; Goya, Masahiko; Sasano, Tetsuo.
Afiliación
  • Shigeta T; Department of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
  • Miyazaki S; Department of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
  • Inaba O; Department of Cardiology, Japanese Red Cross Saitama Hospital, Saitama, Japan.
  • Inamura Y; Department of Cardiology, Japanese Red Cross Saitama Hospital, Saitama, Japan.
  • Nitta J; Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan.
  • Sekiguchi Y; Department of Cardiology, Sakakibara Heart Institute, Tokyo, Japan.
  • Takahashi A; Department of Cardiology, Yokosuka Kyosai Hospital, Kanagawa, Japan.
  • Hachiya H; Cardiovascular Center, Tsuchiura Kyodo Hospital, Ibaraki, Japan.
  • Nagata Y; Department of Cardiology, Japanese Red Cross Musashino Hospital, Tokyo, Japan.
  • Yamauchi Y; Department of Cardiology, Japanese Red Cross Yokohama City Bay Hospital, Kanagawa, Japan.
  • Hayashi T; Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Saitama, Japan.
  • Iwai S; Department of Cardiology, Hiratsuka Kyosai Hospital, Kanagawa, Japan.
  • Mizukami A; Department of Cardiology, Kameda Medical Center, Chiba, Japan.
  • Ono Y; Department of Cardiology, Ome Municipal General Hospital, Tokyo, Japan.
  • Handa K; Division of Cardiology, Kashiwa City Hospital, Chiba, Japan.
  • Suzuki M; Department of Cardiology, Yokohama Minami Kyosai Hospital, Yokohama, Japan.
  • Suzuki A; Heart Center, Tokyo Yamate Medical Center, Tokyo, Japan.
  • Nakajima J; Department of Cardiology, Tokyo Metropolitan Toshima Hospital, Tokyo, Japan.
  • Hirao K; Arrhythmia Advanced Therapy Center, AOI Universal Hospital, Kanagawa, Japan.
  • Okada H; Department of Cardiology, Soka Municipal Hospital, Saitama, Japan.
  • Negishi M; Department of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
  • Ikenouchi T; Department of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
  • Yamamoto T; Department of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
  • Goto K; Department of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
  • Nishimura T; Department of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
  • Tao S; Department of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
  • Takigawa M; Department of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
  • Hirakawa A; Department of Clinical Biostatistics, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.
  • Goya M; Department of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
  • Sasano T; Department of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
Clin Cardiol ; 47(1): e24164, 2024 Jan.
Article en En | MEDLINE | ID: mdl-37822107
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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Venas Pulmonares / Fibrilación Atrial / Ablación por Catéter Tipo de estudio: Clinical_trials Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Cardiol Año: 2024 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Estados Unidos
Texto completo
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Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Venas Pulmonares / Fibrilación Atrial / Ablación por Catéter Tipo de estudio: Clinical_trials Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Cardiol Año: 2024 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Estados Unidos