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.
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 of bradyarrhythmia 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.
Department of Cardiology, Cardiovascular Key Laboratory of Zhejiang Province, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang 310009, China.
Mei-Xiang
MX
Xiang
Department of Cardiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi 710061, China.
Dong-Qi
DQ
Wang
Department of Cardiology, Tianjin Chest Hospital, Tianjin 300051, China.
Jing
J
Xu
Department of Cardiology, The First Hospital of Lanzhou University, Lanzhou, Gansu 730000, China.
Zheng
Z
Zhang
Department of Cardiology, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi 330008, China.
Jian-Xin
JX
Hu
Department of Cardiology, Bethune International Peace Hospital of the Chinese PLA, Shijiazhuang, Hebei 050082, China.
Dong-Mei
DM
Wang
Department of Cardiology, Northern Jiangsu People's Hospital, Yangzhou, Jiangsu 225001, China.
Xiang
X
Gu
Department of Cardiology, Jilin Province People's Hospital, Changchun, Jilin 130021, China.
He-Ping
HP
Liu
Department of Cardiology, The First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan 650032, China.
Tao
T
Guo
Department of Cardiology, The First Affiliated Hospital of Suzhou University, Suzhou, Jiangsu 215006, China.
Xiang-Jun
XJ
Yang
Department of Cardiology, The First People's Hospital of Hangzhou, Hangzhou, Zhejiang 310006, China.
Feng
F
Ling
Department of Cardiology, The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325027, China.
Jia-Feng
JF
Lin
Department of Cardiology, The Affiliated Hospital of Qingdao University Medical College, Qingdao, Shandong 266003, China.
Shang-Lang
SL
Cai
Department of Cardiology, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi 030001, China.
Guo-Bin
GB
Zhu
Department of Cardiology, Cardiovascular Key Laboratory of Zhejiang Province, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang 310009, China.
Jian-An
JA
Wang
D000368:Aged; D001919:Bradycardia / Q000628:therapy; D002304:Cardiac Pacing, Artificial / Q000379:methods*; D002681:China; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D011446:Prospective Studies