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Evaluating the Safety and Effectiveness of 5G Cloud Follow-up for Cardiovascular Implantable Electronic Devices
Sponsor: The Third People's Hospital of Chengdu
Summary
Objective: This clinical study employs a prospective, paired, self-controlled, non-inferiority, multicenter research design to assess the safety and efficacy of utilizing 5G cloud follow-up for CIED in parameters monitoring and remote programming post-implantation. Participants will: undergo regular clinic follow-up visits in accordance with the guidelines undergo routine in-office follow-up and 5G cloud follow-up during each regular clinic visit
Official title: Evaluating the Safety and Effectiveness of 5G Cloud Follow-up for Cardiovascular Implantable Electronic Devices: a Prospective, Paired, Self-controlled, Non-inferiority, Multicenter Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
688
Start Date
2024-11-13
Completion Date
2026-02-01
Last Updated
2024-11-21
Healthy Volunteers
No
Interventions
Routine Management
Conducting routine in-office follow-up for CIED paitents
5G Cloud Follow-up
This study employed a 5G-cloud follow-up platform, a research tool that allows a device specialist to test, and program CIEDs in real-time from a remote location via an internet connection or mobile wireless network. Consistent with of the 5G remote support terminal externally connected to the programmer, a PAD was installed with a 5G-cloud follow-up app. The onsite medical staff began the cloud follow-up session by contacting the remote device specialist via video call. The connection to the CIED was made by the medical staff through the use of a standard programmer. He was in charge of turning on the programmer and applying the programmer wand to the patient's device. After an initial introduction, communication was established and continued via the wand connection. The remote device specialist logged into the 5G-cloud follow-up app with two-step verification. The remote device specialist then had complete control of the programmer to check and reprogram the device as needed.
Locations (2)
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
The Third People's Hospital of Chengdu
Chengdu, Sichuan, China