Tanaka, Makoto
Yanagisawa, Ryo
Yashima, Fumiaki
Arai, Takahide
Watanabe, Yusuke
Naganuma, Toru
Shirai, Shinichi
Araki, Motoharu
Tada, Norio
Yamanaka, Futoshi
Shimizu, Hideyuki
Fukuda, Keiichi
Yamamoto, Masanori
Hayashida, Kentaro http://orcid.org/0000-0002-1750-1982
Funding for this research was provided by:
Edwards Lifesciences
Medtronic
Daiichi Sankyo Company
Article History
Received: 20 November 2019
Accepted: 20 May 2020
First Online: 30 May 2020
Compliance with ethical standards
:
: Dr. Yamamoto, Dr. Tada, Dr. Naganuma, Dr. Shirai, and Dr. Watanabe are clinical proctors for Edwards Lifesciences and Medtronic. Dr. Araki, Dr. Shimizu, and Dr. Hayashida are clinical proctors of Edwards Lifesciences. The remaining authors have nothing to disclose.
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The protocol was initially approved by the institutional review board committee of the Keio University School of Medicine (reference number: 20130270) and was subsequently approved by the ethical committee of each center.
: Informed consent was obtained from all individual participants included in the study.