RecruitingNot ApplicableNCT06652750

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

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

Sponsor

The Third People's Hospital of Chengdu

Enrollment

688 participants

Start Date

Nov 13, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure Atrioventricular Block, Second and Third Degree Sick Sinus Syndrome

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

Min Age: 18 Years

Inclusion Criteria3

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.

Exclusion Criteria4

If meeting any of the following, the individual cannot be included:
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.

Interventions

OTHERRoutine Management

Conducting routine in-office follow-up for CIED paitents

DEVICE5G 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.