1. The clinical use of remote parameter testing during cardiac implantable electronic devices implantation procedures: a single center, randomized, open-label, non-inferiority trial
- Author
-
Shiqiang Xiong, Shujuan Qin, Lin Tong, Yu Long, Yan Luo, Qiao Feng, Xiufen Peng, Maoling Jiang, Feng Xiong, Jin Li, Yangchun Zhang, Zhen Zhang, Hanxiong Liu, and Lin Cai
- Subjects
cardiac implantable electronic devices ,remote testing ,remote interrogation ,remote reprogramming ,implantation ,COVID-19 ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
BackgroundA novel non-contact system for remote parameter testing and reprogramming offers an alternative method for assessing device parameters during cardiac implantable electronic devices (CIEDs) implantation without the need for physical contact with the manufacturer's clinical service technician. The safety and feasibility of using this system in CIEDs implantation procedures remains to be determined.ObjectiveEvaluate the safety and feasibility of remote parameter testing in CIEDs implantation procedures.MethodsA single center, randomized, open-label, non-inferiority trial (ChiCTR2200057587) was conducted to compare the two approaches for interrogating CIEDs during implantation procedures: routine interrogation performed by on-site technicians or remote interrogation performed by technicians using the 5G-Cloud Technology Platform. Patients aged ≥18 years and elected to receive CIEDs were eligible for inclusion. The primary endpoint was the completion rate of the parameter test. Safety and efficiency were evaluated in all randomly assigned participants.ResultsA total of 480 patients were finally enrolled and were randomly assigned to routine group (n = 240) or remote group (n = 240). The primary endpoint was achieved by 100% in both groups (P = 0.0060 for noninferiority). The parameters of sensing, threshold, and impedance regarding the right atrium, right ventricle, and left ventricle had no statistical significance between the two groups (P > 0.05). Procedure time, parameter testing time, and both duration and dose of x-ray irradiation were not significantly different between the two groups (P > 0.05). Shut-open door frequency was significantly higher in the routine group than the remote group [6.00 (4.00, 8.00) vs. 0, P
- Published
- 2024
- Full Text
- View/download PDF