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

NCT06652750 | Recruiting

• 1 other identifier: 2024-S-182-01
• Study Type: interventional
• Target: 688
• Locations: 1 country
• Sites: 2

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

Conditions

Sick Sinus Syndrome; Atrioventricular Block, Second and Third Degree; Heart Failure

Keywords

pacemaker; implantable cardioverter defibrillator; cardiac resynchronization therapy; follow up; remote programming; in-office follow-up

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Parameter Measurement Time

  through study completion, an average of 1 year

• Program Completion Rate

  through study completion, an average of 1 year

• adverse events

  through study completion, an average of 1 year

Study Arms (1)

5G cloud follow-up & Routine follow-up

EXPERIMENTAL

CIED patients undergo both 5G cloud follow-up and routine in-office follow-up during each visit.

Other: Routine Management; Device: 5G Cloud Follow-up

Interventions

Routine Management OTHER

Conducting routine in-office follow-up for CIED paitents

5G cloud follow-up & Routine follow-up

5G Cloud Follow-up DEVICE

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.

5G cloud follow-up & Routine follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third People's Hospital of Chengdu: lead

Study Sites (2)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

RECRUITING

The Third People's Hospital of Chengdu

Chengdu, Sichuan, 610000, China

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Sick Sinus Syndrome; Atrioventricular Block; Neoplasm Metastasis; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms

Central Study Contacts

Lin Cai, master of medicine

CONTACT

8619980510703; clin63@yeah.net

Shiqiang Xiong, Doctor of Medicine(M.D.)

CONTACT

8615377510703; xionglliu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Department of Cardiology

Model Details: During each session, the CIED patient undergoes both the experimental and control methods.

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 22, 2024
• Study Start: November 13, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

CN (2)