Impact of wireless monitoring on heart failure patients
Prospective Multicenter Observation Study on the Association Between Remote Monitoring and Clinical Outcome in Heart Failure Patients (Verifying Remote Monitoring Effect on Net Cardiovascular Outcome; RemoteVerify (RêVe))
This study tests if using wireless monitoring can help heart failure patients with pacemakers and defibrillators stay healthier and reduce unexpected hospital visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Saint Vincent's Hospital, Korea Academic / other |
| Locations | 1 site (Suwon, Kyonggi Do) |
| Trial ID | NCT05971225 on ClinicalTrials.gov |
What this trial studies
This study investigates how wireless monitoring affects the health outcomes of heart failure patients who have implanted pacemakers and defibrillators. It focuses on the frequency of unplanned hospital visits and the early diagnosis of disease exacerbation, comparing patients with and without wireless monitoring. The study also evaluates the progression of the disease and participant satisfaction with the monitoring system.
Who should consider this trial
Good fit: Ideal candidates are heart failure patients with a left ventricular ejection fraction of 40% or less who are new to remote monitoring.
Not a fit: Patients with a life expectancy of less than 6 months or those unable to understand the monitoring system will not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved management and outcomes for heart failure patients through timely interventions.
How similar studies have performed: Previous studies have shown promising results with remote monitoring in heart failure management, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * consented heart failure patients (LVEF\<=40%) with Biotronik wireless monitoring capable ICD/CRTs aged \>20 years * patients who are new to remote monitoring Exclusion Criteria: * For patients with a life expectancy of less than 6 months. If patient do not understand the contents of wireless monitoring or it is difficult to fill out the consent form due to cognitive decline. If wireless monitoring is performed with a patient enrolled in another clinical trial which remote monitoring may affect the previous enrolled study.
Where this trial is running
Suwon, Kyonggi Do
- St. Vincent's Hospital — Suwon, Kyonggi Do, South Korea (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.