Feasibility Study of an Integrated Diagnostic System to Manage Heart Failure

Integrated Diagnostics Can Alter Heart Failure

The purpose of this clinical trial is to evaluate the potential benefits of a new heart failure diagnostic system for heart failure patients with implanted cardiac resynchronization therapy devices. This system consists of patient tools, a new heart failure risk score and a new clinician website. This study will evaluate this new system as a whole and establish the feasibility of implementing it into clinical practice.

Inclusion Criteria:

• Subject is willing and able to provide written informed consent
• Subject is at least 18 years of age
• Subject is willing and able to comply with the Clinical Investigation Plan
• Subject is currently enrolled in the Medtronic CareLink® Network
• Subject is currently a New Heart Association (NYHA) functional class III or NYHA functional class II with a heart failure related hospitalization within the past 180 days
• Subject has a Medtronic Concerto®/Consulta® cardiac resynchronization therapy (CRT)device implanted for at least 180 days
• Subject has been prescribed daily oral diuretic therapy for the management of heart failure

Exclusion Criteria:

• Subject is enrolled in a concurrent study with the exception of a study approved by the INDICATE HF Clinical Trial Leader
• Subject has a life expectancy of less than 1 year
• Subject's CRT device has an estimated battery life of less than 2 years