Verifying Remote Monitoring Effect on Net Cardiovascular Outcome; RemoteVerify (RêVe)
Recruiting · NCT05971225 · Interventional (participants receive a specific treatment) · Lead sponsor: Saint Vincent's Hospital, Korea
View the official record on ClinicalTrials.gov →Interventions studied
remote monitoring only
What this trial is about
This study investigates the impact and safety of wireless monitoring on the prognosis of heart failure patients with implanted pacemakers and defibrillators. It aims to examine the frequency of unplanned early hospital visits and the early diagnosis/intervention of disease exacerbation based on the presence or absence of wireless monitoring. Additionally, the study analyzes the influence of wireless monitoring on the patient's disease progression as well as satisfaction of the study participants.
Who can take part
Age range
20 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- St. Vincent's Hospital - Suwon, Kyonggi Do, South Korea