Actively Recruiting

Phase Not Applicable
Age: 19Years - 80Years
All Genders
NCT05106062

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

457 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Refusal to participate in the trial
  • Refusal to use the remote monitoring system or living in an environment where remote monitoring cannot be used
  • Refusal to use or expected use of less than 75% of the remote monitoring system

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Actively Recruiting

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Research Team

T

Taehoon Kim

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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