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

Study Overview
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Brief Summary
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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).

Detailed Description
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The investigators propose to prospectively recruit 556 patients with ICD or CRT-D implantation in 10 sites in Korea. Eligible patients should be enrolled in remote monitoring system 0 to 45 days after successful device implantation and then randomly assigned in a 1:1 ratio to the RM or conventional follow-up group. In the RM follow-up arm, the patients are not mandated to visit the clinic unless there is unscheduled call due to adverse event notification. In the conventional follow-up arm, the patients should be seen at the clinic according to each center's custom but no longer than 1 year between each visit. Follow-up should be continued accordingly until two-years of device implant.

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

Conditions
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Patients With Defibrillator

Intervention / Treatment
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* Device: on remote monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All ICD and CRT-D patients who are over the age of 18 Ability to provide informed consent and to complete the study and required follow-up Exclusion Criteria: Those who refuse to participate in the trial. Those who refuse to use remote monitoring system or who live in an environment where remote monitoring system cannot be utilized. Patient who refuse to use or expected to use less than 75% of remote monitoring system.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote Monitoring follow up<br>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 | Device: on remote monitoring<br>* 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<br>|
| No Intervention: Conventional Follow up<br>This group will not turn on remote monitoring function of defibrillator. Patient should be seen at clinic according to center's custom but no longer than 6 months between each visit | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Economic benefit by remote monitoring | - Cost Incurred by the patient towards the transportation | up to 2 years | 
| Economic benefit by remote monitoring | - Consultation fee | up to 2 years | 
| Economic benefit by remote monitoring | - Patient Travel Time | up to 2 years | 
| Economic benefit by remote monitoring | - Patient consultation Time | up to 2 years | 
| Economic benefit by remote monitoring | - Administrative activities Time | up to 2 years | 
| Economic benefit by remote monitoring | - Device interrogation Time | up to 2 years | 
| Economic benefit by remotemonitoring | - Cost towards loss of employment for time spent in hospital for check-up of patient | up to 2 years | 
| Economic benefit by remotemonitoring | - Cost towards loss of employment of attendant for time spent in hospital for check-up of patient (dependent) | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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defibrillator, remote monitoring, economic, clinical, benefit