Remote monitoring for patients with heart failure and implanted cardiac devices
REmote MOnitoring of paTiEnts witH pacEmaker or implAntable cardioverteR defibrillaTor
This study tests if better remote monitoring of heart failure patients with implanted devices can help prevent serious health issues and improve their overall care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Semmelweis University Heart and Vascular Center Academic / other |
| Locations | 1 site (Budapest) |
| Trial ID | NCT06173089 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the effectiveness of remote monitoring systems for patients with heart failure who have received implantable cardiac devices such as defibrillators or resynchronization therapy. By utilizing a structured safety-net approach, the study seeks to analyze data from remote monitoring messages and alerts to improve patient outcomes. The primary focus is on reducing non-fatal heart failure events through optimized monitoring and timely interventions based on patient data.
Who should consider this trial
Good fit: Ideal candidates include patients with heart failure and reduced ejection fraction who have a compatible implantable cardiac device capable of home monitoring.
Not a fit: Patients with a life expectancy of less than one year or those unable to comply with monitoring requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of heart failure and potentially reduce hospitalizations and mortality rates in affected patients.
How similar studies have performed: While previous studies have shown some success with remote monitoring in similar patient populations, this specific approach is novel in its structured safety-net methodology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. CRT-P/CRT-D patients with a feasible device for home monitoring 2. ICD (VVI/VDD/DDD) patients with a feasible device for home monitoring 3. SR/AFib 4. Transmission performance \>80% in the first 2 weeks with new device 5. Informed consent Exclusion Criteria: 1. Life expectancy\<1 year 2. Unable to transmit data 3. Patient is unable to visit the physician/clinic in 12 hours when it is indicated by the alerts 4. Expected non-compliance 5. Pregnancy 6. Known drug, alcohol abuse 7. Participation in other study or HM system concept
Where this trial is running
Budapest
- Semmelweis University - Heart and Vascular Center — Budapest, Hungary (Recruiting)
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.