Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure - Full Text View

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 keeps patients out of the hospital longer or delays the time to death.

Condition	Intervention
Heart Disease Cardiomyopathy	Device: Cardiac Compass with OptiVol Fluid Status Monitoring

MedlinePlus related topics:

Cardiomyopathy Heart Diseases Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Official Title:	PRECEDE-HF -Prospective,Randomized Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure

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

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ 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 ]

Estimated Enrollment:	2550
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

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'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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00510198

Contacts


Contact: PRECEDE-HF Study Team		medtroniccrmtrials@medtronic.com

Show 40 Study Locations

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

Medtronic

More Information

Responsible Party:	Medtronic CRDM ( CRDM Core Clinical )
Study ID Numbers:	603
First Received:	July 31, 2007
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00510198
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medtronic Cardiac Rhythm Disease Management:

Heart Disease

Congestive Heart Failure

Thoracic Fluid

Study placed in the following topic categories:

Heart Failure

Heart Diseases

Cardiomyopathies

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2008

Sponsors and Collaborators:	Medtronic Cardiac Rhythm Disease Management Medtronic
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00510198