Evaluating the Safety and Effectiveness of 5G Cloud Follow-up for Cardiovascular Implantable Electronic Devices

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Eligibility

Primary outcome measure(s)

• Parameter Measurement Consistency — through study completion, an average of 1 year
  Subjects underwent in-office follow-up and 5G cloud follow-up to test battery parameters (battery voltage, battery current, and magnet frequency) and lead parameters (amplitude, pacing threshold, and impedance) in the immediate postoperative period, prior to discharge from the hospital, and within 1 month of implantation, within 1 to 3 months of implantation, at 6 months of implantation, and at 12 months of implantation, respectively. The consistency of each parameter measured at both follow-up modalities was analyzed at the end of the trial by regression fitting equations and Pearson correlation coefficients.

Trial sites (2)

More The Third People's Hospital of Chengdu trials in China

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