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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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).

Eligibility

Primary outcome measure(s)

• Major adverse event — up to 2 years
  Definition of major adverse events (MAE) 1. fatal or life-threatening 2. prompted or prolonged a hospitalization; 3. caused major or permanent disability or injury; 4. required an intervention to prevent permanent disability or injury
• Major adverse event, including death from any cause, cardiovascular, and procedure- or device-related MAE. — up to 2 years
  Definition of device-related adverse events 1. delivery of ≥1 inappropriate shock(s); 2. delivery of ≥2 symptomatic inappropriate ATP; 3. symptomatic defibrillator-mediated tachycardia; 4. infection or extrusion of the ICD; 5. ineffective pacing; 6. intermittent or permanent undersensing; 7. clinical phrenic stimulation; and 8. lead or pulse generator dysfunction.

Trial sites (1)

More Yonsei University trials in South Korea