Heart Failure Clinical Trial
Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure
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.
Full 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
SentryCheckâ„¢ Monitor
OptiVol Alert Suspend (OptiVol enhancement)
OptiVol Reference Impedance Adjustment (OptiVol enhancement)
Eligibility Criteria
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
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There are 33 Locations for this study
Anchorage Alaska, 99508, United States
Little Rock Arkansas, 72205, United States
Berkeley California, 94705, United States
Larkspur California, 94939, United States
Colorado Springs Colorado, 80909, United States
Fort Collins Colorado, 80528, United States
Jacksonville Florida, 32207, United States
Atlanta Georgia, 30306, United States
Kankakee Illinois, 60901, United States
Oak Lawn Illinois, 60453, United States
Rockford Illinois, 61107, United States
Indianapolis Indiana, 46260, United States
Louisville Kentucky, 40205, United States
New Orleans Louisiana, 70121, United States
Takoma Park Maryland, 20912, United States
Springfield Massachusetts, 01199, United States
Saginaw Michigan, 48601, United States
Ypsilanti Michigan, 48197, United States
Saint Cloud Minnesota, 56303, United States
Saint Joseph Missouri, 64501, United States
Saint Louis Missouri, 63110, United States
Albany New York, 12212, United States
Akron Ohio, 44304, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Elyria Ohio, 44035, United States
Oklahoma City Oklahoma, 73120, United States
Doylestown Pennsylvania, 18901, United States
Lancaster Pennsylvania, 17603, United States
Nashville Tennessee, 37205, United States
Austin Texas, 78705, United States
Richmond Virginia, 23294, United States
Milwaukee Wisconsin, 53215, United States
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