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.

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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)

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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

Study is for people with:

Heart Failure

Estimated Enrollment:

120

Study ID:

NCT00510198

Recruitment Status:

Terminated

Sponsor:

Medtronic Cardiac Rhythm and Heart Failure

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There are 33 Locations for this study

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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

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

120

Study ID:

NCT00510198

Recruitment Status:

Terminated

Sponsor:


Medtronic Cardiac Rhythm and Heart Failure

How clear is this clinincal trial information?

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