Cardiac Resynchronization Therapy, Congestive Heart Failure, Defibrillators
Conditions
Keywords
remote monitoring, congestive heart failure, Defibrillators, cardiac resynchronization therapy
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.
Interventions
remote monitoring only can replace in-office device monitoring
Sponsors
Biotronik SE & Co. KG
Saint Vincent's Hospital, Korea
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
one group with experience of in-office device monitoring \>6 months the other group without experience of in-office device monitoring
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac-related deaths | 6,12,18,24 months | Cardiac cause deaths |
| Overall mortality | 6,12,18,24 months | overall deaths |
| 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 |
Countries
South Korea
Outcome results
None listed