title: Regulatory controversy on the pediatric ventricular assist device trial in Japan.
authors.affiliation: Department of Intellectual Asset Management, Research and Development Initiative Center, National Cerebral and Cardiovascular Center, Osaka, Japan.
authors.forename: Haruka
authors.initials: H
authors.lastname: Nakada
authors.affiliation: Department of Cardiovascular Surgery, Jichi Medical University, Saitama Medical Center, Saitama, Saitama, Japan; Department of Cardiothoracic Surgery, School of Medicine, Stanford University, Palo Alto, California.
authors.forename: Mamoru
authors.initials: M
authors.lastname: Arakawa
authors.affiliation: Department of Intellectual Asset Management, Research and Development Initiative Center, National Cerebral and Cardiovascular Center, Osaka, Japan.
authors.forename: Eisuke
authors.initials: E
authors.lastname: Tatsumi
mesh_terms: D002648:Child; D002986:Clinical Trials as Topic; D006333:Heart Failure / Q000628:therapy*; D006353:Heart-Assist Devices / Q000592:standards*; D006801:Humans; D007564:Japan