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The main goal is to learn how HeartInsight is used in clinical routine care. HeartInsight is a heart failure monitoring and notification tool within BIOTRONIK's Home Monitoring System. HeartInsight combines patient data as collected by the implanted devices to alert the attending physicians to impending worsening of heart failure events of the patients. This study will create a sound and seamless documentation of approximately 150 HeartInsight alerts, their processing, subsequent interventions and disease progressions. The data will be analyzed to characterize and quantify the use of HeartInsight in a clinical routine set-up.The patient population consists of heart failure patients with BIOTRONIK CRT-D devices that support HeartInsight.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeartInsight activation | Other | HeartInsight is activated at enrollment. The attending physicians are free on how to integrate HeartInsight in the patient care. Any treatment is based on routine care according to guidleines. Only documentation occurs on how the physicians use HeartInsight and actions taken in response to HeartInsight alerts |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of WHF hospitalization after HeartInsight activation | Calculation of worsening heart failure hospitalization events per patient year during study participation when HeartInsight is active | through study completion, an average of 1.5 years |
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Inclusion Criteria:
Exclusion Criteria:
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HeartFailure patients will be recruited by their primary care clinic based on the in/exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemocnice Ceske Budejovice, a.s. | České Budějovice | Czechia | ||||
| Fakultní nemocnice Olomouc |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 7, 2026 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Olomouc |
| Czechia |
| CHU de Brest | Brest | France |
| Semmelweis University | Budapest | Hungary |
| The University of Pécs | Pécs | Hungary |
| Pauls Stradins Clinical University Hospital | Riga | Latvia |
| Hospital de Santa Maria | Lisbon | Portugal |