Using 5G technology for follow-up care of heart 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
This study is testing if using 5G technology for remote check-ups can be as safe and effective as regular in-person visits for people with heart devices like pacemakers and defibrillators.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 688 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Third People's Hospital of Chengdu Academic / other |
| Locations | 2 sites (Guangzhou, Guangdong and 1 other locations) |
| Trial ID | NCT06652750 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the safety and effectiveness of 5G cloud follow-up for patients with cardiovascular implantable electronic devices (CIED) such as pacemakers and defibrillators. It employs a prospective, paired, self-controlled, non-inferiority design across multiple centers to compare traditional in-office follow-ups with remote monitoring via 5G technology. Participants will receive both types of follow-up during their regular clinic visits to assess the feasibility and outcomes of remote programming. The study aims to enhance patient monitoring and timely intervention while reducing the need for hospital visits.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have recently received a cardiovascular implantable electronic device and have not yet undergone their first follow-up.
Not a fit: Patients with a life expectancy of less than one year or those unable to cooperate with treatment or follow-up will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management and monitoring of patients with heart devices, leading to better health outcomes.
How similar studies have performed: While remote monitoring has been explored in other studies, the specific application of 5G cloud follow-up for CIEDs is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong and 1 other locations
- Sun Yat-sen Memorial Hospital — Guangzhou, Guangdong, China (Recruiting)
- The Third People's Hospital of Chengdu — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Lin Cai, master of medicine
- Email: clin63@yeah.net
- Phone: 8619980510703
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.