NCT05106062 Economic and Clinical Benefit of Remote Monitoring Among Defibrillator Patients by Indication Subgroups (BENEFIT-RM)
| NCT ID | NCT05106062 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yonsei University |
| Condition | Patients With Defibrillator |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,140 participants |
| Start Date | 2020-12-21 |
| Primary Completion | 2029-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,140 participants in total. It began in 2020-12-21 with a primary completion date of 2029-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. All ICD and CRT-D patients who are over the age of 18 2. Ability to provide informed consent and to complete the study and required follow-up Exclusion Criteria: 1. Those who refuse to participate in the trial. 2. Those who refuse to use remote monitoring system or who live in an environment where remote monitoring system cannot be utilized. 3. Patient who refuse to use or expected to use less than 75% of remote monitoring system.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05106062 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 80 Years, studying Patients With Defibrillator. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05106062 currently recruiting?
Yes, NCT05106062 is actively recruiting participants. Contact the research team at thkimcardio@yuhs.ac for enrollment information.
Where is the NCT05106062 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05106062 clinical trial?
NCT05106062 is sponsored by Yonsei University. The trial plans to enroll 1,140 participants.