Clinical trial NCT00510198: Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure
Official title: PRECEDE-HF -Prospective, Randomized Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: Heart Disease
Congestive Heart Failure
Thoracic Fluid Monitoring
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2007-08-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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)

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

Primary outcomes:
measure: Number of Participants With Heart-Failure Hospitalization or All-Cause Death
timeFrame: Up to five years
measure: 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
timeFrame: Up to five years
Secondary outcomes:
measure: Combined Endpoint of All-cause Mortality and Cardiovascular Hospitalizations
timeFrame: up to five years
measure: Cardiovascular Hospitalizations
timeFrame: up to five years
Other outcomes:
Locations:
city: Anchorage
country: United States
state: Alaska
city: Little Rock
country: United States
state: Arkansas
city: Berkeley
country: United States
state: California
city: Larkspur
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Fort Collins
country: United States
state: Colorado
city: Jacksonville
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Kankakee
country: United States
state: Illinois
city: Oak Lawn
country: United States
state: Illinois
city: Rockford
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Takoma Park
country: United States
state: Maryland
city: Springfield
country: United States
state: Massachusetts
city: Saginaw
country: United States
state: Michigan
city: Ypsilanti
country: United States
state: Michigan
city: Saint Cloud
country: United States
state: Minnesota
city: Saint Joseph
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Albany
country: United States
state: New York
city: Akron
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Elyria
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Doylestown
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Medtronic
name: PRECEDE-HF Study Team
role: STUDY_CHAIR
References: