Study of Economic and Clinical Benefits of Remote Monitoring for Patients With Implanted Defibrillators

What this Trial Is About

Researchers are investigating the economic and clinical benefits of remote monitoring RM for patients with implantable defibrillators ICD or cardiac resynchronizing therapy defibrillators CRT-D. This study aims to identify which subgroups of defibrillator patients benefit most from RM by comparing outcomes across different indication groups. The study is being conducted as a prospective clinical trial in the Korean population to help guide recommendations for RM use. The study will enroll 556 patients who have received ICD or CRT-D implants. Participants will be randomly assigned to one of two groups one group will have their RM function activated within 0 to 45 days after implantation and will typically visit the clinic once a year unless an adverse event occurs. The other group will follow conventional care without RM, attending clinic visits at intervals no longer than six months depending on center practice. Follow-up will continue for up to two years after device implantation. Participants will be monitored for major adverse events, including death from any cause, cardiovascular issues, and device- or procedure-related problems, over the two-year period. Economic benefits of RM will also be evaluated during this time. Study involvement includes scheduled clinic visits, remote monitoring alerts, and routine follow-up assessments to track health outcomes and healthcare costs. The total participation duration is two years with ongoing safety and clinical evaluations.

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