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RECRUITING
NCT06652750
NA

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

Sponsor: The Third People's Hospital of Chengdu

View on ClinicalTrials.gov

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

OTHER

Routine Management

Conducting routine in-office follow-up for CIED paitents

DEVICE

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