Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure

Inclusion Criteria

• •The following criteria apply to all subjects:
• •Subject has a CRT-D or dual chamber ICD with Cardiac Compass and OptiVol Fluid Status Monitoring implanted in the pectoral region at least 30 days prior to enrollment. CRT-D/ICD must be supported by the Medtronic CareLink Network.
• •Subject has a market-released, transvenous, high voltage RV lead
• •Subject has a market-released RA lead
• •If subject has an LV lead, it must be compatible, not Y-adapted and not currently under investigation
• •Subject's heart failure regimen (i.e. beta blocker and ACE inhibitor (or substitute) unless documented evidence of intolerance is available) adheres to current ACC/AHA guidelines for management of chronic heart failure in adult patients
• •Subject has a history of at least one heart failure related hospitalization, Emergency Department (ED) visit, or urgent visit necessitating IV diuretic, IV inotropic, IV vasodilator, or other parenteral therapy within 12 months prior to baseline evaluation
• •Subject is at least 18 years of age
• •Subject is willing and able to comply with the Clinical Investigation Plan (e.g. willing and able to remain available for follow-up visits, use SentryCheck, etc.)
• •Subject is willing and able to transmit data using the Medtronic CareLink Network
• •Subject (or subject's legally authorized representative) is willing and able to sign and date the study Informed Consent and HIPAA Authorization (U.S.)