Integrated Diagnostic for Heart Failure

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.

Primary outcomes

• 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 outcomes

• 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

Sex: All, ages: 18 Years to any

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

• Sean Virani, MD, Principal investigator, Vancouver General Hospital, Vancouver, British Columbia, Canada