Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure

Inclusion Criteria:

Subject (or subject's legally authorized representative) is willing and able to provide written informed consent
Subject has been implanted with a CRT device for at least 9 months and has had a wireless Medtronic CRT-D device for at least 34 days
Subject has >1 year life expectancy
Subject's CRT-D device has at least 18 months of device longevity left
Subject has an eGFR> 25 ml/min/1.73 m2
Subject is NYHA Class II or III
Subject is NYHA Class II or III • Subject has elevated BNP values (BNP>400 or NTpro BNP>800) within the last 3 months OR Subject has had at least one OptiVol threshold crossing in the last 9 months OR Subject has had a HF event within the last 9 months

HF event is defined as meeting any one of the following two criteria:

Subject was admitted to the hospital for worsening HF OR

Subject has received Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any settings including:

Emergency Department
Ambulance
Observation Unit
Urgent Care
HF/Cardiology Clinic

Patient's Home

Subjects who are currently prescribed and taking medications for the management of heart failure and are able to tolerate transient increases in diuretic dosage
Subject is willing and able to comply with the protocol, including screening, baseline and programming visit(s), remote care directions, follow-up visits, and exit visit
Subject can send device transmissions and daily biometric data with in-home patient devices

Exclusion Criteria

Subject has systolic BP of < 90 mmHg at the time of enrollment
Subject not responsive to diuretic therapy or is on chronic renal dialysis
Subject unable to undergo one round of medication intervention (3 day up-titration of diuretic) without requiring safety check
Subjects enrolled in a concurrent study that may confound the results of this study without documented pre-approval from a Medtronic study manager
Subject weighs more than 500 pounds
Subject is younger than 18 years of age
Subject has hemodynamic monitoring device implanted