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

PRECEDE-HF -Prospective, Randomized Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure

The purpose of the PRECEDE-HF study is to collect data to compare patients whose heart failure is managed using Cardiac Compass with OptiVol (which is a tool in the device that records information about the heart that doctors can use to help treat their heart disease) combined with standard treatment methods (Access Group) to patients whose heart failure is managed by standard treatment methods only (Control Group). This comparison will show if the additional monitoring provided by Cardiac Compass with OptiVol delays the time patients are first admitted to hospital for heart failure or delays the time to death.

PRECEDE-HF was a prospective, multi-center, randomized, investigational device exemption (IDE) clinical study. The purpose of this study was to collect data required to determine whether the use of Cardiac Compass including OptiVol Fluid Status Monitoring with standard clinical assessment ("Access Arm") will result in a longer time to first heart failure hospitalization or death compared to standard clinical assessment alone ("Control Arm") and to support the approval of the following device features:

• OptiVol Alert (audible and home monitor alerts) for use in Medtronic devices
• SentryCheck™ Monitor
• OptiVol Alert Suspend (OptiVol enhancement)
• OptiVol Reference Impedance Adjustment (OptiVol enhancement)

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.)

Exclusion Criteria

The following criteria apply to all subjects:

• Subject is post heart transplant or actively listed on the transplant list and reasonable probability (as defined by investigator) of undergoing transplantation in the next year
• Subject received a coronary artery bypass graft or valve surgery in the last 90 days
• Subject had a myocardial infarction (MI) in the last 90 days.
• Subject is indicated for valve replacement/repair
• Subject's life expectancy due to non-cardiac reasons is less than six months
• Subject has serum creatinine > 2.5 mg/dL measured within 30 days prior to enrollment.
• Subject is on chronic renal dialysis
• Subject is on continuous or intermittent (> 2 stable infusions per week) infusion therapy for HF
• Subject has complex and uncorrected congenital heart disease
• Subject is enrolled in a Disease Management Program where an outside vendor, company or service is employed to determine, monitor, and/ or alert a clinician or subject to weight changes or other HF signs or symptoms via interactive or passive systems
• Subject is implanted with a cardiac hemodynamic monitor or left ventricular assist device(LVAD)
• Subject is enrolled in a concurrent study, with the exception of a study approved by the Medtronic PRECEDE-HF Clinical Trial Leader prior to enrollment