Review of Pre-market Clinical Trials for Cardiac Implantable Electronic Devices in the United States
ZENG Zhiyu1,2, LI Bo1, DANG Dawei1, HAN Lei1, ZHANG Mingdong1
1. Boston Scientific International Medical Trading (Shanghai) Co., Ltd., Beijing 100125, China;
2. School of Public Health, Peking University, Beijing 100191, China
Abstract：We reviewed the pre-market clinical trials for cardiac implantable electronic devices in the United States manufactured by
the three largest companies: Boston Scientific, Medtronic and St. Jude Medical. The review focused on clinical trial design, study
endpoints and sample size, which would provide reference to similar endeavors in China.
曾治宇1,2，李波1，党大伟1，韩磊1，张明东1. 美国心脏植入型电子器械上市前临床研究回顾[J]. 中国医疗设备, 2019, 34(1): 159-162.
ZENG Zhiyu1,2, LI Bo1, DANG Dawei1, HAN Lei1, ZHANG Mingdong1. Review of Pre-market Clinical Trials for Cardiac Implantable Electronic Devices in the United States. China Medical Devices, 2019, 34(1): 159-162.
