Clinical trial · Interventional
Evaluating the Safety and Effectiveness of 5G Cloud Follow-up for Cardiovascular Implantable Electronic Devices
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
NCT06652750CI-TRIAL-00082832CIED-CARErecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atrioventricular Block, Second and Third Degree | — | UNRESOLVED | — |
| Heart Failure | — | UNRESOLVED | — |
| Sick Sinus Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5G Cloud Follow-up | Device | — | UNRESOLVED |
| Routine Management | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 5G cloud follow-up & Routine follow-up
- description
- CIED patients undergo both 5G cloud follow-up and routine in-office follow-up during each visit.
- interventionNames
- Other: Routine Management
- Device: 5G Cloud Follow-up
Primary outcomes (1)
- measure
- Parameter Measurement Consistency
- timeFrame
- through study completion, an average of 1 year
- description
- 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.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDXiong 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
- BACKGROUNDXiong 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
- BACKGROUNDTong 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
- BACKGROUNDTong 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