Heart Failure
Conditions
Keywords
Heart Failure, HFRS, OptiVol, ICD, CRT-D
Brief summary
A prospective post-market study to evaluate the performance and clinic usability of heart failure risk status (HFRS) feature on CareLink.
Detailed description
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.
Interventions
None listed
Sponsors
Medtronic
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is 18 years of age or older * Patient ( or patient's legally authorized representative) is willing and able to provide written informed consent * Patient is willing and able to comply with the required study follow up visits * Patient is implanted with a Medtronic wireless ICD or CRT-D device capable of OptiVol fluid monitoring feature * Patient is on Medtronic CareLink network or is willing to be enrolled on the CareLink network * Patient is being managed, or has been managed, by a HF clinician * Patient has signed an informed consent for CareLink Network Services * Patient is implanted with device for at least three months * Patient is willing and able to transmit data using the CareLink home monitor (2490C).
Exclusion criteria
* Patient is participating in another study that may interfere with TRIAGE-HF protocol required procedures * Patient with an implantable cardiac device that is indicated to reach ERI in less than 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Failure Risk Status Performance Characterization | from baseline until a subject completes 8 months of follow up | The clinical signs and symptoms of worsening HF that are associated with an Heart Failure Risk Status triggered by an OptiVol alert |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Failure Risk Status and medical management | from baseline for each subject until they complete 8 months of follow up | The correlation between HFRS burden and clinician's assessment of a subject risk and the subject's medical management |
Countries
Canada
Outcome results
None listed