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RECRUITING
NCT05106062
NA

Economic and Clinical Benefit of Remote Monitoring Among Defibrillator Patients by Indication Subgroups (BENEFIT-RM)

Sponsor: Yonsei University

View on ClinicalTrials.gov

Summary

Remote monitoring is now universally available for all cardiac implantable electronic devices (CIEDs), and it has become the standard of care for the management of patients with these devices. In many countries, it is being proven that patients with implantable defibrillator (ICD) or cardiac resynchronizing therapy (CRT) can benefit from remote monitoring (RM) both economically and clinically. From previous RM related clinical studies, it is reasonably accepted that hospitalization cost and mortality rate is comparably higher in defibrillator patients compared to pacemaker indicated patients. However, it is yet to be discovered which group of defibrillator patients are the most beneficiaries using remote monitoring system. In this study, the investigators would further categorize defibrillator patients into different indication subgroups and compare both economic and clinical benefits among different indication. By comparing economic and clinical benefits of remote monitoring by different subgroups, the investigators might be able to set a guideline on which group of patients should be strongly suggested for remote monitoring utilization. Therefore, the investigators perform a prospective study in Korean population to compare economic and clinical benefits of RM compared to conventional follow-up in overall study cohort and by different subgroups. (ICD \& CRT-D).

Key Details

Gender

All

Age Range

19 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1140

Start Date

2020-12-21

Completion Date

2029-09-30

Last Updated

2024-08-23

Healthy Volunteers

No

Interventions

DEVICE

on remote monitoring

This group will turn on the RM function 0 to 45 days after defibrillator implantation. Patient should be seen at clinic once a year, or if there is any adverse event notification

Locations (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea