Remote monitoring for patients with pacemakers
Evaluation of Clinical and Economic Benefit Using Remote Monitoring in Patients With Pacemaker (REMOTE-PM)
This study is testing if remote monitoring for patients with pacemakers is as safe and effective as regular in-person check-ups.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06043570 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 who have received a permanent pacemaker with remote monitoring capabilities.
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.
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 performed: Previous studies have indicated that remote monitoring can be a safe alternative to traditional follow-up methods, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Seoul
- Severance Cardiovascular Hospital Yonsei University — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Boyoung Joung
- 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.