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
Age ≥ 18 years, gender unspecified;
Patients who have not undergone their first clinic follow-up after the implantation of cardiovascular implantable electronic devices (CIED); Note: In this study, CIED includes pacemakers, implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy pacemakers (CRT-P) and defibrillators (CRT-D), excluding implantable cardiac event recorders (ICM) and implantable cardiovascular monitors.
Willing to participate in this clinical study and have signed the informed consent form in writing.
Life expectancy < 1 year.
Inability to cooperate with treatment or follow-up, such as having mental illness.
Participated in other clinical studies within 30 days before enrollment. Other situations that the researcher deems unsuitable for inclusion.
Single group
Routine Management
Other interventionConducting routine in-office follow-up for CIED paitents
5G Cloud Follow-up
DeviceThis 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.
Parameter Measurement Consistency
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.
Parameter Measurement Time
During each follow-up, all subjects undergo separate routine in-office follow-ups and 5G cloud follow-ups. The time taken from the beginning of device interrogation to the completion of parameter testing is recorded for each follow-up.
Program Completion Rate
Evaluation Approach: Participants undergo both in-person clinic follow-up and 5G cloud follow-up during each appointment. Researchers will evaluate and programe the device in accordance with the current guidelines. The assessment of program completion will be conducted through the Program Control Completion Assessment Form. Completion Criteria: If all parameter reprogramming statuses are indicated as "Yes", the program control session will be deemed as complete. In cases where any program control completion status is marked as "No", the session's program control will be considered incomplete. Program Completion Rate is calculated as follows: the number of successful programming / the total number of programming
adverse events
Subjects are observed and recorded at any time during the study process after enrollment. Summarize the occurrence of adverse events and calculate the rate of adverse events. Participants will be continuously monitored and documented during each follow-up session. The adverse event is defined according to the "Guidelines for Reporting Adverse Events and Device Defects" in the present study. Investigators will record and summarize the occurrence of adverse events and determine the rate of adverse event incidence. The rate of adverse event is calculated as the number of participants occurring adverse event/ the total number of the participants.
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