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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
remote monitoring only
Other interventionremote monitoring only can replace in-office device monitoring
Treatment groups
450 Participants
are divided into 2 treatment groupsGroup A: Follow up groupActive comparator 1 intervention
Group B: Remote groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Unplanned early visits for cardiac causes1 (Patient)
i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits
Time frame
6 months2
Unplanned early visits for cardiac causes2 (Patient)
i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits
Time frame
12months3
Unplanned early visits for cardiac causes3 (Patient)
i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits
Time frame
18months4
Unplanned early visits for cardiac causes4 (Patient)
i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits
Time frame
24monthsSecondary outcomes
1
Acute myocardial infarction (heart attack) or cerebrovascular events (stroke)
ACS, CVA
Time frame
6,12,18,24 months2
Thromboembolic events (such as pulmonary embolism)
Systemic thromboembolic events
Time frame
6,12,18,24 months3
Worsening of heart failure leading to hospitalization
HF related admission
Time frame
6,12,18,24 months4
Cardiac-related deaths
Cardiac cause deaths
Time frame
6,12,18,24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Saint Vincent's Hospital, Korea
Lead sponsor
Biotronik SE & Co. KG
Collaborator
Source ClinicalTrials.gov