Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652750
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Evaluating the Safety and Effectiveness of 5G Cloud Follow-up for Cardiovascular Implantable Electronic Devices
Sponsor:
None
Organization:
None
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 andor 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None