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))
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congestive Heart Failure
- Sponsor
- Saint Vincent's Hospital, Korea
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Unplanned early visits for cardiac causes1 (Patient)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
Unplanned early visits for cardiac causes1 (Patient)
Time Frame: 6 months
i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits
Unplanned early visits for cardiac causes2 (Patient)
Time Frame: 12months
i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits
Unplanned early visits for cardiac causes4 (Clinic)
Time Frame: 24months
ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -\> Clinician-driven early visits
Unplanned early visits for cardiac causes3 (Patient)
Time Frame: 18months
i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits
Unplanned early visits for cardiac causes4 (Patient)
Time Frame: 24months
i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits
Unplanned early visits for cardiac causes1 (Clinic)
Time Frame: 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)
Time Frame: 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)
Time Frame: 18months
ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -\> Clinician-driven early visits
Secondary Outcomes
- Acute myocardial infarction (heart attack) or cerebrovascular events (stroke)(6,12,18,24 months)
- Thromboembolic events (such as pulmonary embolism)(6,12,18,24 months)
- Worsening of heart failure leading to hospitalization(6,12,18,24 months)
- Cardiac-related deaths(6,12,18,24 months)
- Overall mortality(6,12,18,24 months)