Evaluating the Safety and Effectiveness of 5G Cloud Follow-up for Cardiovascular Implantable Electronic Devices
Recruiting · NCT06652750 · Interventional (participants receive a specific treatment) · Lead sponsor: The Third People's Hospital of Chengdu
View the official record on ClinicalTrials.gov →Interventions studied
5G Cloud Follow-upRoutine Management
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- Exclusion Criteria:
- 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.
- Participated in other clinical studies within 30 days before enrollment. Other situations that the researcher deems unsuitable for inclusion.
Where it is running
2 locations listed.
- Sun Yat-sen Memorial Hospital - Guangzhou, Guangdong, China
- The Third People's Hospital of Chengdu - Chengdu, Sichuan, China