Verifying Remote Monitoring Effect on Net Cardiovascular Outcome; RemoteVerify (RêVe)
- Conditions
- Congestive Heart FailureCardiac Resynchronization TherapyDefibrillators
- Registration Number
- NCT05971225
- Lead Sponsor
- Saint Vincent's Hospital, Korea
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
- consented heart failure patients (LVEF<=40%) with Biotronik wireless monitoring capable ICD/CRTs aged >20 years
- patients who are new to remote monitoring
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Unplanned early visits for cardiac causes1 (Patient) 6 months i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits
Unplanned early visits for cardiac causes2 (Patient) 12months i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits
Unplanned early visits for cardiac causes3 (Patient) 18months i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits
Unplanned early visits for cardiac causes4 (Patient) 24months i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits
Unplanned early visits for cardiac causes1 (Clinic) 6months ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -\> Clinician-driven early visits
Unplanned early visits for cardiac causes2 (Clinic) 12months ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -\> Clinician-driven early visits
Unplanned early visits for cardiac causes3 (Clinic) 18months ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -\> Clinician-driven early visits
Unplanned early visits for cardiac causes4 (Clinic) 24months ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -\> Clinician-driven early visits
- Secondary Outcome Measures
Name Time Method Acute myocardial infarction (heart attack) or cerebrovascular events (stroke) 6,12,18,24 months ACS, CVA
Thromboembolic events (such as pulmonary embolism) 6,12,18,24 months Systemic thromboembolic events
Worsening of heart failure leading to hospitalization 6,12,18,24 months HF related admission
Cardiac-related deaths 6,12,18,24 months Cardiac cause deaths
Overall mortality 6,12,18,24 months overall deaths
Trial Locations
- Locations (1)
St. Vincent's Hospital
🇰🇷Suwon, Kyonggi do, Korea, Republic of
St. Vincent's Hospital🇰🇷Suwon, Kyonggi do, Korea, Republic of