Remote monitoring for patients with pacemakers
Official title: Evaluation of Clinical and Economic Benefit Using Remote Monitoring in Patients With Pacemaker (REMOTE-PM)
Run by Yonsei University · NCT06043570 · Data updated 2026-11-12
This study is testing if remote monitoring for patients with pacemakers is as safe and effective as regular in-person check-ups.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 900 (estimated) |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | January 17, 2023 |
| Main results expected | October 2025 |
| Study ends | December 2027 |
| Registry record updated | September 21, 2023 |
| Trial ID | NCT06043570 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-80 who have received a permanent pacemaker with remote monitoring capabilities.
✕Probably not a fit
Patients with severe organ dysfunction, certain heart diseases, or those who refuse to use the remote monitoring system may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of remote monitoring (RM) technology for patients with implanted pacemakers compared to traditional in-person follow-ups. The study will enroll 900 patients in Korea, who will be randomly assigned to either the RM group or the standard care group. The primary objective is to determine if the rate of major adverse events is similar between the two groups, while secondary objectives will assess the economic benefits of RM and develop guidelines tailored to the Korean context. The trial will also explore the feasibility of implementing a reimbursement policy for remote monitoring services.
Why it matters
Potential benefit: If successful, this study could enhance patient care by providing a safer and more efficient follow-up method for pacemaker recipients.
How similar studies have gone: Previous studies have indicated that remote monitoring can be a safe alternative to traditional follow-up methods, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Age: 18-80 years
* Patients with permanent pacemaker with SenseAbility feature \& RM
* Ability to provide informed consent and to complete the study and required follow-up ④ Those who refuse to use remote monitoring system or who live in an environment where remote monitoring system cannot be utilized.
* Patient who refuse to use or expected to use less than 75% of remote monitoring system.
Exclusion Criteria:
* Severe hepatic and renal insufficiency (AST or ALT ≥ three times of normal upper limit; SCr \> 3.5 mg/dl or Ccr \< 30ml/min)
* Thyroid gland dysfunction
* Pregnancy ④ Malignant tumor
* Severe organic heart disease (such as moderate to severe mitral regurgitation, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease)
* Life expectancy \< 12 months ⑦ Patients unable or unwilling to cooperate in the study procedures.
Where it's running
-
Severance Cardiovascular Hospital Yonsei University
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Boyoung Joung
- Email: thkimcardio@yuhs.ac
- Phone: +82 02-2228-8460
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.