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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

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Chinese Medical Journal 2016年第22期129卷 2659-2665页

作者： Mei-Xiang Xiang Dong-Qi Wang Jing Xu Zheng Zhang Jian-Xin Hu Dong-Mei Wang Xiang Gu He-Ping Liu Tao Guo Xiang-Jun Yang Feng Ling Jia-Feng Lin Shang-Lang Cai Guo-Bin Zhu Jian-An Wang Department of Cardiology Cardiovascular Key Laboratory of Zhejiang Province The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang 310009 China Department of Cardiology The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi 710061 China Department of Cardiology Tianjin Chest Hospital Tianjin 300051 China Department of Cardiology The First Hospital of Lanzhou University Lanzhou Gansu 730000 China Department of Cardiology The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi 330008 China Department of Cardiology Bethune International Peace Hospital of the Chinese PLA Shijiazhuang Hebei 050082 China Department of Cardiology Northern Jiangsu People's Hospital Yangzhou Jiangsu 225001 China Department of Cardiology Jilin Province People's Hospital Changchun Jilin 130021. China Department of Cardiology The First Affiliated Hospital of Kunming Medical University Kunming Yunnan 650032 China Department of Cardiology The First Affiliated Hospital of Suzhou University Suzhou Jiangsu 215006 China Department of Cardiology The First People's Hospital of Hangzhou Hangzhou Zhejiang 310006 China Department of Cardiology The Second Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang 325027 China Department of Cardiology The Affiliated Hospital of Qingdao University Medical College Qingdao Shandong 266003 China Department of Cardiology The Second Hospital of Shanxi Medical University Taiyuan Shanxi 030001 China

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 ofqinming8631 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 ofqinming8631 DR to Talos DR.The safety and efficacy ofqinming8631 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

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