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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).
The investigators propose to prospectively recruit 556 patients with ICD or CRT-D implantation in 10 sites in Korea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Monitoring follow up | Experimental | 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 |
|
| Conventional Follow up | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| on remote monitoring | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse event | Definition of major adverse events (MAE)
| 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
| up to 2 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Taehoon Kim | Contact | +82 02-2228-8460 | thkimcardio@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | South Korea |
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| 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 |