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

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

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 Overview

• Status: Recruiting
• Conditions: Heart Failure; Sick Sinus Syndrome; Atrioventricular Block, Second and Third Degree
• Intervention / Treatment: Other: Routine Management; Device: 5G Cloud Follow-up

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

• Study Type: Interventional
• Enrollment (Estimated): 688
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lin Cai, master of medicine; Phone Number: 8619980510703; Email: clin63@yeah.net
• Study Contact Backup: Name: Shiqiang Xiong, Doctor of Medicine(M.D.); Phone Number: 8615377510703; Email: xionglliu@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-Sen Memorial Hospital
      • Contact: Juan Lei; Phone Number: 8613650894373; Email: leijuan@mail.sysu.edu.cn
      • Contact: Shuxian Zhou, MD
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Recruiting
      • The Third People's Hospital of Chengdu
      • Contact: Yan Luo, master of medicine; Phone Number: 8618090809034; Email: luoyan31566@163.com
      • Contact: Lin Cai, master of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years, gender unspecified;
2. 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.
3. Willing to participate in this clinical study and have signed the informed consent form in writing.

Exclusion Criteria:

• Exclusion Criteria:

If meeting any of the following, the individual cannot be included:

1. Life expectancy < 1 year.
2. Inability to cooperate with treatment or follow-up, such as having mental illness.
3. Participated in other clinical studies within 30 days before enrollment. Other situations that the researcher deems unsuitable for inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 5G cloud follow-up & Routine follow-up; CIED patients undergo both 5G cloud follow-up and routine in-office follow-up during each visit.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parameter Measurement Consistency	Subjects underwent in-office follow-up and 5G cloud follow-up to test battery parameters (battery voltage, battery current, and magnet frequency) and lead parameters (amplitude, pacing threshold, and impedance) in the immediate postoperative period, prior to discharge from the hospital, and within 1 month of implantation, within 1 to 3 months of implantation, at 6 months of implantation, and at 12 months of implantation, respectively. The consistency of each parameter measured at both follow-up modalities was analyzed at the end of the trial by regression fitting equations and Pearson correlation coefficients.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parameter Measurement Time	During each follow-up, all subjects undergo separate routine in-office follow-ups and 5G cloud follow-ups. The time taken from the beginning of device interrogation to the completion of parameter testing is recorded for each follow-up.	through study completion, an average of 1 year
Program Completion Rate	Evaluation Approach: Participants undergo both in-person clinic follow-up and 5G cloud follow-up during each appointment. Researchers will evaluate and programe the device in accordance with the current guidelines. The assessment of program completion will be conducted through the Program Control Completion Assessment Form. Completion Criteria: If all parameter reprogramming statuses are indicated as "Yes", the program control session will be deemed as complete. In cases where any program control completion status is marked as "No", the session's program control will be considered incomplete. Program Completion Rate is calculated as follows: the number of successful programming / the total number of programming	through study completion, an average of 1 year
adverse events	Subjects are observed and recorded at any time during the study process after enrollment. Summarize the occurrence of adverse events and calculate the rate of adverse events. Participants will be continuously monitored and documented during each follow-up session. The adverse event is defined according to the "Guidelines for Reporting Adverse Events and Device Defects" in the present study. Investigators will record and summarize the occurrence of adverse events and determine the rate of adverse event incidence. The rate of adverse event is calculated as the number of participants occurring adverse event/ the total number of the participants.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: The Third People's Hospital of Chengdu

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: cardiac resynchronization therapy; implantable cardioverter defibrillator; pacemaker; follow up; remote programming; in-office follow-up
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Block; Arrhythmia, Sinus; Atrioventricular Block; Sick Sinus Syndrome
• Other Study ID Numbers: 2024-S-182-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The datasets in the study might be available upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No