Sick Sinus SyndromeAtrioventricular Block, Second and Third DegreeHeart Failure
Investigational drug(s) / intervention(s)
Routine Management5G Cloud Follow-up
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 years, gender unspecified;
2. 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.
3. Willing to participate in this clinical study and have signed the informed consent form in writing.
Exclusion Criteria:
* Exclusion Criteria:
If meeting any of the following, the individual cannot be included:
1. Life expectancy \< 1 year.
2. Inability to cooperate with treatment or follow-up, such as having mental illness.
3. Participated in other clinical studies within 30 days before enrollment. Other situations that the researcher deems unsuitable for inclusion.
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)
Facility
City
Region
Status
Sun Yat-sen Memorial Hospital
Guangzhou
Guangdong
Recruiting
The Third People's Hospital of Chengdu
Chengdu
Sichuan
Recruiting
More The Third People's Hospital of Chengdu trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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