Verifying Remote Monitoring Effect on Net Cardiovascular Outcome; RemoteVerify (RêVe)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorSaint Vincent's Hospital, Korea
About this trial
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.
Eligibility criteria
Qualifiers
consented heart failure patients (LVEF<=40%) with Biotronik wireless monitoring capable ICD/CRTs aged >20 years
patients who are new to remote monitoring
Disqualifiers
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.
Trial design
Treatments tested in this trial
- remote monitoring only
Treatment groups
450 Participants
are divided into 2 treatment groupsSponsors and collaborators
Saint Vincent's Hospital, Korea
Lead sponsor
Biotronik SE & Co. KG
Collaborator
Source ClinicalTrials.gov