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

Not Applicable

Terminated

Interventions: Device: Standard of Care alone (clinical assessment)
Device: Cardiac Compass with OptiVol Fluid Status Monitoring

Brief Summary: 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.

Detailed Description: 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)

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Control Arm 2: SOC	Standard of Care alone (clinical assessment)	Intervention is Standard of Care alone, such as assessment of symptoms, only. Device trending information, but OptiVol is not allowed.
Control Arm 1: SOC and CC with OptiVol	Cardiac Compass with OptiVol Fluid Status Monitoring	Standard of Care and Cardiac Compass with OptiVol as the Control. Intervention is standard of care, such as symptom assessment with the addition of viewing Cardiac Compass trends and the OptiVol diagnostic.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Heart-Failure Hospitalization or All-Cause Death	Up to five years	A composite endpoint of heart-failure hospitalization or all-cause death. To demonstrate a longer time to first heart failure (HF) hospitalization or death in HF subjects managed with standard clinical assessment using Cardiac Compass Trends with OptiVol Fluid Status Monitoring ("Access Arm") compared to HF subjects managed with standard clinical assessment alone ("Control Arm")
Number of Subjects Proportion Who Have a Safety Composite Event Within the First 6 Months Post-randomization Between the Access Arm and the Control Arm	Up to five years	A safety composite event is defined as an event that includes one or more of the following: Syncope, Worsening renal function resulting in IV therapy, ultrafiltration, or dialysis, Hypotension and/or hypovolemia resulting in the administration of IV fluids, Clinically significant electrolyte abnormalities resulting in IV replacement or ER/hospitalization for correction, Appropriately detected sustained VT/VF episode, Death

Secondary Outcome Measures

Name	Time	Method
Combined Endpoint of All-cause Mortality and Cardiovascular Hospitalizations	up to five years	To demonstrate a reduction in the combined endpoint of all-cause mortality and cardiovascular hospitalizations in the Access Arm compared to the Control Arm
Cardiovascular Hospitalizations	up to five years	To demonstrate a reduction in cardiovascular hospitalizations in the Access Arm compared to the Control Arm