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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Third People's Hospital of Chengdu

About this 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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Routine Management
  • 5G Cloud Follow-up

Treatment groups

688 Participants
are divided into 1 treatment group