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| Name | Class |
|---|---|
| Biotronik SE & Co. KG | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Follow up group | Active Comparator | participants with experience of >6 months in-office device interrogation, then started remote monitoring |
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| Remote group | Experimental | participants with newly implanted device with study agreement, and then started remote monitoring |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remote monitoring only | Other | remote monitoring only can replace in-office device monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Unplanned early visits for cardiac causes1 (Patient) | i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits | 6 months |
| Unplanned early visits for cardiac causes2 (Patient) | i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits | 12months |
| Unplanned early visits for cardiac causes3 (Patient) | i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits | 18months |
| Unplanned early visits for cardiac causes4 (Patient) | i. Unplanned hospitalization/admission due to patient's condition changes -> Patients' needs-driven early visits | 24months |
| Unplanned early visits for cardiac causes1 (Clinic) | ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits | 6months |
| Unplanned early visits for cardiac causes2 (Clinic) | ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits | 12months |
| Unplanned early visits for cardiac causes3 (Clinic) | ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits |
| Measure | Description | Time Frame |
|---|---|---|
| Acute myocardial infarction (heart attack) or cerebrovascular events (stroke) | ACS, CVA | 6,12,18,24 months |
| Thromboembolic events (such as pulmonary embolism) | Systemic thromboembolic events |
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Inclusion Criteria:
Exclusion Criteria:
If wireless monitoring is performed with a patient enrolled in another clinical trial which remote monitoring may affect the previous enrolled study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's Hospital | Recruiting | Suwon | Kyonggi Do | 16247 | South Korea |
It will not be open because its sensitive data, however, if there's reasonable request, data can be acquired after de-identification of the participants.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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one group with experience of in-office device monitoring >6 months the other group without experience of in-office device monitoring
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| 18months |
| Unplanned early visits for cardiac causes4 (Clinic) | ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -> Clinician-driven early visits | 24months |
| 6,12,18,24 months |
| Worsening of heart failure leading to hospitalization | HF related admission | 6,12,18,24 months |
| Cardiac-related deaths | Cardiac cause deaths | 6,12,18,24 months |
| Overall mortality | overall deaths | 6,12,18,24 months |