Journal Article

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

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

2016

Overview

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.

• Publisher: Wolters Kluwer India Pvt. Ltd,Medknow Publications and Media Pvt. Ltd,Lippincott Williams & Wilkins Ovid Technologies,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,Medknow Publications & Media Pvt Ltd,Wolters Kluwer
• Subject: Aged / Bradyarrhythmia; Cardiac Pacemaker; Qinming8631; Safety and Efficacy / Bradycardia / Bradycardia - therapy / Cardiac arrhythmia / Cardiac Pacing, Artificial - methods / Cardiology / Care and treatment / China / Electrocardiography / Electrodes / Female / Hospitals / Humans / Laboratories / Male / Middle Aged / Mortality / Neuromuscular diseases / Original / Pacemaker, Artificial - adverse effects / Pacemakers / Prospective Studies / 中国 / 安全性 / 心脏起搏器 / 患者 / 植入式 / 疗效评价 / 随机对照试验