Evaluating the benefits of remote monitoring for defibrillator patients
Economic and Clinical Benefit of Remote Monitoring Among Defibrillator Patients by Indication Subgroups (BENEFIT-RM)
This study is testing if remote monitoring can help people with defibrillators or heart devices stay healthier and save money compared to regular check-ups.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1140 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05106062 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the economic and clinical benefits of remote monitoring for patients with implantable defibrillators (ICD) or cardiac resynchronizing therapy (CRT). It will categorize patients into different indication subgroups and compare the outcomes of those using remote monitoring versus conventional follow-up. A total of 556 patients will be recruited across 10 sites in Korea, with participants randomly assigned to either the remote monitoring group or the conventional follow-up group. The study will track these patients for two years post-device implantation to evaluate the effectiveness of remote monitoring.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have received an ICD or CRT-D device and can provide informed consent.
Not a fit: Patients who refuse to participate in the trial or cannot utilize the remote monitoring system due to environmental constraints may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and outcomes for defibrillator patients through optimized remote monitoring strategies.
How similar studies have performed: Previous studies have shown positive outcomes with remote monitoring in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul
- Severance Hospital, Yonsei University Health System — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Taehoon Kim
- Email: thkimcardio@yuhs.ac
- Phone: +82 02-2228-8460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.