Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
Study NCT ID:
NCT06652750
Status:
RECRUITING
Last Update Posted:
2024-11-21
First Post:
2024-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Safety and Effectiveness of 5G Cloud Follow-up for Cardiovascular Implantable Electronic Devices
Sponsor:
The Third People's Hospital of Chengdu
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIED-CARE
Brief 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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: