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.
Study Type
OBSERVATIONAL
Enrollment
100
Vancouver General Hospital
Vancouver, British Columbia, Canada
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
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
Time frame: from baseline until a subject completes 8 months of follow up
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
Time frame: from baseline for each subject until they complete 8 months of follow up
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