Actively Recruiting
Economic and Clinical Benefit of Remote Monitoring Among Defibrillator Patients by Indication Subgroups (BENEFIT-RM)
Led by Yonsei University · Updated on 2024-08-23
1140
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Economic and Clinical Benefit of Remote Monitoring Among Defibrillator Patients by Indication Subgroups (BENEFIT-RM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 to 80 years
- Patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronizing therapy defibrillator (CRT-D)
- Ability to provide informed consent
- Ability to complete the study and required follow-up
You will not qualify if you...
- Individuals who refuse to participate in the trial
- Individuals who refuse to use remote monitoring or live in an environment where remote monitoring cannot be used
- Patients who refuse or are expected to use remote monitoring less than 75% of the time
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 0 to 45 days after implantation
Participants receive implantation of an implantable cardioverter defibrillator (ICD) or cardiac resynchronizing therapy defibrillator (CRT-D).
1 visit to activate remote monitoring function for participants randomized to remote monitoring group
Duration - Up to 2 years
Participants are followed either through remote monitoring or conventional in-clinic visits according to group assignment.
Remote monitoring group: 1 clinic visit per year or visits if adverse events occur; Conventional follow-up group: clinic visits up to every 6 months
Trial Site Locations
Total: 1 location
1
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Actively Recruiting
Research Team
T
Taehoon Kim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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