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题名: Evaluation of Safety and Efficacy of Qinming8631 DR Implantable Cardiac Pacemaker in Chinese Patients: A Prospective, Multicenter, Randomized Controlled Trial of the First Domestically Developed Pacemaker of China
作者: Xiang, MX; Wang, DQ; Xu, J; Zhang, Z; Hu, JX; Wang, DM; Gu, X; Liu, HP; Guo, T; Yang, XJ; Ling, F; Lin, JF; Cai, SL; Zhu, GB; Wang, JA
收录类别: SCIE ; PubMed ; MEDLINE
出版日期: 2016-11-20
刊名: CHINESE MEDICAL JOURNAL
卷号: 129, 期号:22, 页码:2659+
期刊主办单位: 中华医学会
出版者: MEDKNOW PUBLICATIONS & MEDIA PVT LTD
出版地: MUMBAI
英文摘要: Background: High cost of imported pacemakers is a main obstacle for Chinese patients suffering from bradyarrhythmia, and a domestically developed pacemaker will help lower the burden. This study aimed to evaluate the safety and efficacy of Qinming8631 DR (Qinming Medical, Baoji, China), the first domestically developed dual-chamber pacemaker of China, compared with a commercially available pacemaker Talos DR (Biotronik, Berlin, Germany) in Chinese patients. Methods: A prospective randomized trial was conducted at 14 centers in China. Participants were randomized into trial (Qinming8631 DR) and control (Talos DR) groups. Parameters of the pacing systems were collected immediately after device implantation and during follow-ups. The effective pacing rate at 6-month follow-up was recorded as the primary end point. Electrical properties, magnet response, single-and double-pole polarity conversion, rate response function, and adverse events of the pacing system were analyzed. The Cochran-Mantel-Haenszel Chi-square test, paired t-test, and Wilcoxon signed-rank test were used for measuring primary qualitative outcomes and comparing normally and abnormally distributed measurement data. Results: A total of 225 patients with a diagnosis ofbradyarrhythmia and eligible for this study were randomly enrolled into the trial (n = 113) and control (n = 112) groups. They underwent successful pacemaker implantation with acceptable postoperative pacing threshold and sensitivity. Effective pacing rates of trial and control groups were comparable both in the full analysis set and the per protocol set (81.4% vs. 79.5%, P = 0.712 and 95.4% vs. 89.5%, P=0.143, respectively). In both data sets, noninferiority of the trial group was above the predefined noninferiority limit(-9.5%). Conclusions: This study established the noninferiority of Qinming8631 DR to Talos DR. The safety and efficacy of Qinming8631 DR pacemaker were comparable to those of Talos DR in treating patients with cardiac bradyarrhythmia.
关键词: Bradyarrhythmia ; Cardiac Pacemaker ; Qinming8631 ; Safety and Efficacy
作者部门: [Xiang, Mei-Xiang ; Wang, Jian-An] Zhejiang Univ, Dept Cardiol, Cardiovasc Key Lab Zhejiang Prov, Sch Med,Affiliated Hosp 2, Hangzhou 310009, Zhejiang, Peoples R China ; [Wang, Dong-Qi] Xi An Jiao Tong Univ, Dept Cardiol, Affiliated Hosp 1, Xian 710061, Shaanxi, Peoples R China ; [Xu, Jing] Tianjin Chest Hosp, Dept Cardiol, Tianjin 300051, Peoples R China ; [Zhang, Zheng] Lanzhou Univ, Dept Cardiol, Hosp 1, Lanzhou 730000, Gansu, Peoples R China ; [Hu, Jian-Xin] Nanchang Univ, Dept Cardiol, Affiliated Hosp 2, Nanchang 330008, Jiangxi, Peoples R China ; [Wang, Dong-Mei] Chinese PLA, Bethune Int Peace Hosp, Dept Cardiol, Shijiazhuang 050082, Hebei, Peoples R China ; [Gu, Xiang] Northern Jiangsu Peoples Hosp, Dept Cardiol, Yangzhou 225001, Jiangsu, Peoples R China ; [Liu, He-Ping] Jilin Prov Peoples Hosp, Dept Cardiol, Changchun 130021, Jilin, Peoples R China ; [Guo, Tao] Kunming Med Univ, Dept Cardiol, Affiliated Hosp 1, Kunming 650032, Yunnan, Peoples R China ; [Yang, Xiang-Jun] Suzhou Univ, Dept Cardiol, Affiliated Hosp 1, Suzhou 215006, Jiangsu, Peoples R China ; [Ling, Feng] First Peoples Hosp Hangzhou, Dept Cardiol, Hangzhou 310006, Zhejiang, Peoples R China ; [Lin, Jia-Feng] Wenzhou Med Univ, Dept Cardiol, Affiliated Hosp 2, Wenzhou 325027, Zhejiang, Peoples R China ; [Cai, Shang-Lang] Qingdao Univ, Dept Cardiol, Affiliated Hosp, Coll Med, Qingdao 266003, Shandong, Peoples R China ; [Zhu, Guo-Bin] Shanxi Med Univ, Dept Cardiol, Hosp 2, Taiyuan 030001, Shanxi, Peoples R China
通讯作者: Wang, JA (reprint author), Zhejiang Univ, Dept Cardiol, Cardiovasc Key Lab Zhejiang Prov, Sch Med,Affiliated Hosp 2, Hangzhou 310009, Zhejiang, Peoples R China.
学科分类: General & Internal Medicine
文章类型: Article
语种: 英语
DOI: 10.4103/0366-6999.193443
ISSN号: 0366-6999
WOS记录号: WOS:000387990100003
PM记录号: 27823996
IR记录号: WOS:000387990100003
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内容类型: 期刊论文
URI标识: http://ir.lzu.edu.cn/handle/262010/188645
Appears in Collections:第一临床医学院_期刊论文

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Recommended Citation:
Xiang, MX,Wang, DQ,Xu, J,et al. Evaluation of Safety and Efficacy of Qinming8631 DR Implantable Cardiac Pacemaker in Chinese Patients: A Prospective, Multicenter, Randomized Controlled Trial of the First Domestically Developed Pacemaker of China[J]. CHINESE MEDICAL JOURNAL,2016,129(22):2659+.
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