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

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether remote follow-up care using a 5G cloud-based monitoring system is as safe and effective as in-person clinic visits for patients who have had a heart device (like a pacemaker, defibrillator, or cardiac resynchronization device) implanted. **You may be eligible if...** - You are 18 or older - You have recently had your first heart implant device (pacemaker, ICD, CRT-P, or CRT-D) and have not yet had your first follow-up clinic visit - Your doctor believes remote monitoring is appropriate for you **You may NOT be eligible if...** - You have had a previous heart device implant before this one - You have an implantable loop recorder or other device not included in the study - You are unable or unwilling to use the remote monitoring system Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(2)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

The Third People's Hospital of Chengdu

Chengdu, Sichuan, China

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NCT06652750

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