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A prospective post-market study to evaluate the performance and clinic usability of heart failure risk status (HFRS) feature on CareLink.
Patients with systolic heart failure (HF) implanted with Medtronic wireless implantable cardiac defibrillator (ICD) or cardiac resynchronization therapy device with defibrillation capabilities (CRT-D) devices will be enrolled in the study. The purpose of the study is to evaluate the usability of CareLink HFRS to manage a patient's heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no treatment | non-randomized, all subjects who have been implanted with an ICD or CRT-D for at least 3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Heart Failure Risk Status Performance Characterization | The clinical signs and symptoms of worsening HF that are associated with an Heart Failure Risk Status triggered by an OptiVol alert | from baseline until a subject completes 8 months of follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Failure Risk Status and medical management | The correlation between HFRS burden and clinician's assessment of a subject risk and the subject's medical management | from baseline for each subject until they complete 8 months of follow up |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with heart failure who have been implanted with an ICD or a CRT-D wirless device for at least 3 months
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| Name | Affiliation | Role |
|---|---|---|
| Sean Virani, MD | Vancouver General Hospital, Vancouver, British Columbia, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada | ||
| St. Boniface Hospital |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006480 | Hemorrhagic Fever with Renal Syndrome |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D018778 | Hantavirus Infections |
| D002044 | Bunyaviridae Infections |
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| Winnipeg |
| Manitoba |
| R2H 2A6 |
| Canada |
| Southlake Regional Health Centre | Newmarket | Ontario | L3Y 2P9 | Canada |
| D012327 |
| RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D006482 | Hemorrhagic Fevers, Viral |