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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
History of Changes
  Purpose

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.


Condition Intervention
Congestive Heart Failure
 Device: Cardiac Compass with OptiVol Fluid Status Monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: PRECEDE-HF -Prospective, Randomized Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 120
Study Start Date: October 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Standard of Care and Cardiac Compass with OptiVol
 Device: Cardiac Compass with OptiVol Fluid Status Monitoring
Review of Cardiac Compass with OptiVol Fluid Status Monitoring
Active Comparator: 2
Standard of Care alone
 Device: Cardiac Compass with OptiVol Fluid Status Monitoring
Review of Cardiac Compass with OptiVol Fluid Status Monitoring

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510198

  Show 33 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: PRECEDE-HF Study Team Medtronic
  More Information

No publications provided

Responsible Party: CRDM Core Clinical, Medtronic CRDM
ClinicalTrials.gov Identifier: NCT00510198     History of Changes
Other Study ID Numbers: 603
Study First Received: July 31, 2007
Last Updated: June 8, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Heart Disease
Congestive Heart Failure
Thoracic Fluid Monitoring

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013