Multicenter prospective observational study to clarify the current status and clinical outcome in Japanese patients who have an indication for implantable cardioverter defibrillator (ICD) or wearable cardioverter defibrillator (WCD) (TRANSITION JAPAN-ICD/WCD study): Rationale and design of a prospective, multicenter, observational, comparative study.
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Ikeya Yukitoshi, Okumura Yasuo, Kogawa Rikitake, Nagashima Koichi, Nakai Toshiko, Yokoyama Katsuaki, Iso Kazuki, Kato Takeshi, Tsuda Toyonobu, Tachibana Eizo, Hayashida Satoshi, Fukaya Hidehira, Ishizue Naruya, Hayashi Hidemori, Kuroda Shunsuke, Sonoda Kazumasa, Nakahara Shiro, Hori Yuichi, Harada Masahide, Murakami Masato, Iwasaki Yu-Ki, Aizawa Yoshiyasu, Shimizu Wataru, Fukamizu Seiji, Takami Mitsuru, Kusano Kengo, Ishibashi Kohei, Harada Tomoo, Nakajima Ikutaro, Tabuchi Haruna, Kunimoto Mitsuhiro, Shoda Morio, Higuchi Satoshi, Morishima Itsuro, Kanzaki Yasunori, Kato Ritsushi, Ikeda Yoshifumi, Makimoto Hisaki, Kabutoya Tomoyuki, Kario Kazuomi, Arimoto Takanori, Ninomiya Yuichi, Yoshimoto Issei, Sasaki Shingo, Kondo Yusuke, Chiba Toshinori, Yamashita Kennosuke, Mizuno Yosuke, Inoue Masaru, Ueyama Takeshi, Koyama Jyunjiro, Tsurugi Takuo, Orita Yoshiya, Asano Taku, Shinke Toshiro, Tanno Kaoru, Murotani Kenta, TRANSITION JAPAN‐ICD/WCD study
Аннотация
METHODS: We are initiating a prospective multicenter observational study for HFrEF patients eligible for ICD in primary and secondary prevention, and WCD, regardless of device use, including all consenting patients. Study subjects are to be enrolled from 31 participant hospitals located throughout Japan from April 1, 2023, to December 31, 2024, and each will be followed up for 1 year or more. The planned sample size is 651 cases. The primary endpoint is the rate of cardiac implantable electronic device implementation. Other endpoints include the incidence of VT/VF and sudden death, all-cause mortality, and HF hospitalization, other events. We will collect clinical background information plus each patient's symptoms, Clinical Frailty Scale score, laboratory test results, echocardiographic and electrocardiographic parameters, and serial changes will also be secondary endpoints.
RESULTS: Not applicable.
CONCLUSION: This study offers invaluable insights into understanding the role of ICD/WCD in Japanese HF patients in the new era of HF medication.