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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
120
Review of Cardiac Compass with OptiVol Fluid Status Monitoring
Clinical assessment utilizing standard of care, alone.
Unnamed facility
Anchorage, Alaska, United States
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Little Rock, Arkansas, United States
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Berkeley, California, United States
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Larkspur, California, United States
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Colorado Springs, Colorado, United States
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Fort Collins, Colorado, United States
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Jacksonville, Florida, United States
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Atlanta, Georgia, United States
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Kankakee, Illinois, United States
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Oak Lawn, Illinois, United States
...and 23 more locations
Number of Participants With Heart-Failure Hospitalization or All-Cause Death
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")
Time frame: Up to five years
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
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
Time frame: Up to five years
Combined Endpoint of All-cause Mortality and Cardiovascular Hospitalizations
To demonstrate a reduction in the combined endpoint of all-cause mortality and cardiovascular hospitalizations in the Access Arm compared to the Control Arm
Time frame: up to five years
Cardiovascular Hospitalizations
To demonstrate a reduction in cardiovascular hospitalizations in the Access Arm compared to the Control Arm
Time frame: up to five years
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