Congestive Heart Failure Clinical Trial
Official title:
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)
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