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Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure (PRECEDE-HF)

This study has been terminated.
(Study enrollment significantly below protocol expectation)
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00510198
First received: July 31, 2007
Last updated: June 8, 2009
Last verified: June 2009

July 31, 2007
June 8, 2009
October 2007
April 2009   (final data collection date for primary outcome measure)
  • Demonstrate a longer time to first heart failure hospitalization or death in the treatment arm. [ Time Frame: Up to five years ] [ Designated as safety issue: No ]
  • Demonstrate that the proportion of subjects in the treatment arm experiencing a safety composite event at 6 months is not worse than that in the control arm [ Time Frame: Up to five years ] [ Designated as safety issue: Yes ]
  • Evaluate a longer time to first HF hospitalization or death in HF subjects managed with standard assessment using Cardiac Compass Trends with OptiVol Fluid Status Monitoring compared to HF subjects managed with standard assessment alone [ Time Frame: Up to five years ]
  • Evaluate that the proportion of subjects in the Access Arm experiencing a safety composite event at 6 months is not worse than the proportion of subjects in the Control Arm [ Time Frame: Up to five years ]
Complete list of historical versions of study NCT00510198 on ClinicalTrials.gov Archive Site
  • Evaluate the combined endpoint of all-cause mortality and cardiovascular hospitalizations. [ Time Frame: Up to five years ] [ Designated as safety issue: No ]
  • Evaluate a reduction in cardiovascular and HF hospitalizations. [ Time Frame: Up to five years ] [ Designated as safety issue: No ]
  • Evaluate the combined endpoint of all-cause mortality and cardiovascular hospitalizations. [ Time Frame: Up to five years ]
  • Evaluate a reduction in cardiovascular and HF hospitalizations. [ Time Frame: Up to five years ]
Not Provided
Not Provided
 
Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure
PRECEDE-HF -Prospective, Randomized Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Congestive Heart Failure
Device: Cardiac Compass with OptiVol Fluid Status Monitoring
Review of Cardiac Compass with OptiVol Fluid Status Monitoring
  • Active Comparator: 1
    Standard of Care and Cardiac Compass with OptiVol
    Intervention: Device: Cardiac Compass with OptiVol Fluid Status Monitoring
  • Active Comparator: 2
    Standard of Care alone
    Intervention: Device: Cardiac Compass with OptiVol Fluid Status Monitoring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
120
April 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00510198
603
Yes
CRDM Core Clinical, Medtronic CRDM
Medtronic Cardiac Rhythm Disease Management
Not Provided
Study Chair: PRECEDE-HF Study Team Medtronic
Medtronic Cardiac Rhythm Disease Management
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP