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

Официальное название

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

Обзор

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

Подробное описание

Background: Cardiovascular implantable electronic devices (CIED) include pacemakers, implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy (CRT) pacemakers and defibrillators, implantable cardiac event recorders (ICM), and implantable cardiovascular monitors. They are mainly used for the diagnosis, monitoring, and treatment of bradycardia, tachycardia, and heart failure (HF). There are currently two main methods of follow-up: routine in-office follow-up and remote monitoring (RM). Routine in-office follow-up is the most commonly used method in China, whereby professional doctors and/or manufacturer engineers conduct follow-ups under the guidance of physicians. Remote monitoring (RM) allows patients to be remotely monitored at home or elsewhere when a communication network is available, receiving periodic alerts related to the patient. Remote monitoring (RM) can provide timely and accurate CIED data and information, promptly alerting clinical doctors to any issues. However, a drawback is that patients still need to visit the hospital for device parameter adjustments, so it only partially fulfills the functions of routine in-office follow-up. Of note, in the past three years, some domestic clinical centers in China have begun exploring the application of 5G cloud follow-up remote programming (5G Cloud Follow Up) in various patient follow-up scenarios. With the comprehensive deployment of 5G networks in China, central hospitals with specialized device programmers can establish one-to-one or one-to-many regional collaborative cloud follow-up systems with primary hospitals lacking follow-up technician through 5G networks. CIED patients only need to visit nearby primary hospitals to complete regular device follow-ups. Currently, excellent research results have been obtained in the quality control of the CIED follow-ups of a single provincial medical consortium system mainly consisting of major implantation centers. However, there is still a lack of verification results for 5G cloud follow-up remote programming in a medical consortium (MC) model covering various administrative regions in China and different levels of primary hospitals. This study will compare the safety and effectiveness of using 5G cloud follow-up remote programming in different administrative regions and levels of primary hospitals in China with routine in-office follow-ups.

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

Вмешательства

• Другое Routine Management
  Conducting routine in-office follow-up for CIED paitents
• Устройство 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 CI

Первичные конечные точки

• Parameter Measurement Consistency [Срок оценки: through study completion, an average of 1 year]

Вторичные конечные точки (3)

• Parameter Measurement Time [Срок оценки: through study completion, an average of 1 year]
• Program Completion Rate [Срок оценки: through study completion, an average of 1 year]
• adverse events [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Exclusion Criteria:

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Китай · 2 центра

• Sun Yat-sen Memorial Hospital — Гуанчжоу
• The Third People's Hospital of Chengdu — Чэнду

Публикации

• Xiong S, Qin S, Tong L, Long Y, Luo Y, Feng Q, Peng X, Jiang M, Xiong F, Li J, Zhang Y, Zhang Z, Liu H, Cai L. The clinical use of remote parameter testing during cardiac implantable electronic devices implantation procedures: a single center, randomized, open-label, non-inferiority trial. Front Cardiovasc Med. 2024 Mar 22;11:1364940. doi: 10.3389/fcvm.2024.1364940. eCollection 2024. PMID 38586175
• Xiong S, Li J, Tong L, Hou J, Yang S, Qi L, Chen X, Luo Y, Zhang Z, Liu H, Cai L. Realtime Remote Programming in Patients Carrying Cardiac Implantable Electronic Devices Requiring Emergent Reprogramming. Front Cardiovasc Med. 2022 May 16;9:871425. doi: 10.3389/fcvm.2022.871425. eCollection 2022. PMID 35651905
• Tong L, Xiong S, Hou J, Li J, Qin S, Zhang Y, Yang S, Qi L, Chen X, Luo Y, Zhang Z, Deng H, Liu H, Cai L. Cloud Follow-Up in Patients With Cardiovascular Implantable Electronic Devices: A Single-Region Study in China. Front Cardiovasc Med. 2022 May 9;9:864398. doi: 10.3389/fcvm.2022.864398. eCollection 2022. PMID 35615564
• Tong L, Long Y, Xiong S, Li J, Huang W, Liu H, Cai L. Application of Postoperative Remote Follow-Up of CIED Based on the 5G Cloud Technology Support Platform in Areas With Underdeveloped Medical Resources. Front Cardiovasc Med. 2022 Jun 17;9:894345. doi: 10.3389/fcvm.2022.894345. eCollection 2022. PMID 35783847

Идентификаторы

NCT: NCT06652750 · 2024-S-182-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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