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

NCT05106062 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1140

Last updated 2024-08-23

No results posted yet for this study

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).

Conditions

  • Patients With Defibrillator

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-21
Primary Completion
2029-09-30
Completion
2029-09-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05106062 on ClinicalTrials.gov