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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The Third People's Hospital of Chengdu
RECRUITING
Chengdu
Sun Yat-sen Memorial Hospital
RECRUITING
Guangzhou
Contact Information
Primary
Lin Cai, master of medicine
clin63@yeah.net
8619980510703
Backup
Shiqiang Xiong, Doctor of Medicine(M.D.)
xionglliu@163.com
8615377510703
Time Frame
Start Date: 2024-11-13
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 688
Treatments
Experimental: 5G cloud follow-up & Routine follow-up
CIED patients undergo both 5G cloud follow-up and routine in-office follow-up during each visit.
Sponsors
Leads: The Third People's Hospital of Chengdu

This content was sourced from clinicaltrials.gov