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Authors
Tamura, Yuichi https://orcid.org/0000-0002-4437-8019
Takata, Tomohiro
Taniguchi, Hirohisa
Takemura, Ryo
Takechi, Mineki
Takeyasu, Rika
Watanabe, Eiichi
Yada, Hirotaka
Tamura, Yudai
Iwasawa, Jin
Taniguchi, Tadahiro
Ogawa, Satoshi
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Funding
Funding for this research was provided by:
Japan Agency for Medical Research and Development (21hk0102071h0003)
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Article History
Received: 5 October 2025
Accepted: 2 December 2025
First Online: 27 December 2025
Declarations
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: Yuichi Tamura, Tomohiro Takata, Hirohisa Taniguchi and Mineki Takechi are shareholders of CardioIntelligence, Inc. Ryo Takemura, Rika Takeyasu, Eiichi Watanabe, Hirotaka Yada, Yudai Tamura, Jin Iwasawa, Tadahiro Taniguchi, and Satoshi Ogawa have nothing to disclose
: This clinical trial was performed at the Satoshi Ogawa Clinic, Bantane Hospital, Fujita Health University and University of Health and Welfare Mita Hospital following the ethical principles based on the Declaration of Helsinki, the Law concerning the Assurance of the Quality, Efficacy and Safety of Drugs and Medical Devices (Law on Drugs and Medical Devices, etc.), and the Ministerial Ordinance Concerning Standards for Conducting Clinical Studies on Medical Devices (Medical Device Good Clinical Practice (GCP). Use of retrospective Holter ECG data for algorithm development and the prospective multicenter clinical study were approved by the International University of Health and Welfare – Institutional Review Board (Approval No. fm-1-2101-081). Trial registration: UMIN-CTR UMIN000047182.
