Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure
The INTERVENE-HF study is a prospective, non-randomized, multi-center (US only), investigational, feasibility study. The purpose of this study is to characterize safety of managing heart failure patients with integrated device diagnostics that have an implanted commercially available Medtronic cardiac resynchronization therapy defibrillator (CRT-D).
• 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