Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)
NCT ID: NCT00643279
Last Updated: 2023-12-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
277 participants
INTERVENTIONAL
2003-03-31
2013-04-30
Brief Summary
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Detailed Description
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After baseline evaluation and verification that entrance criteria were met, all subjects were implanted with a Chronicle IHM and pressure sensor lead. Following successful implantation, subjects were randomized to either the CHRONICLE group or CONTROL group. Subjects randomized to the CHRONICLE group were managed using Chronicle, specifically trended RV and estimated PA pressure, heart rate and activity data, whereas subjects randomized to the CONTROL group were treated conventionally without the use of the Chronicle data. In the case that implantation was not successful, subjects were exited from the study if no procedure related adverse events were identified; procedure related adverse events were followed through to resolution before the subject were withdrawn from the study.
Subjects remained randomized until their six month clinic visit had been completed. Following the subject's six month visit, clinicians were granted access to the CONTROL subject's trended Chronicle data on the Chronicle website, and subjects were seen in the clinic for a protocol-required visit every six months until exit from the study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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CHRONICLE
Subjects randomized to the CHRONICLE group were managed using data from an implantable hemodynamic monitoring (IHM) device, including trended right ventricular (RV) and estimated pulmonary arterial (PA) pressures, heart rate and activity data. The Chronicle IHM device does not provide therapy, but rather provides intracardiac diagnostic information about the patient which the physician can utilize to manage the patient and the patients heart failure.
Chronicle Implantable Hemodynamic Monitor
Surgical implantation of chronic ambulatory implantable hemodynamic monitoring (IHM) device and intracardiac pressure sensing lead. The implantable hemodynamic monitoring device captures intracardiac hemodynamic information about the patient including trended right ventricular (RV) and estimated pulmonary arterial (PA) pressures, heart rate and activity data. The IHM device does not provide therapy, but rather provides intracardiac diagnostic information about the patient which the physician can utilize to manage the patient and the patients heart failure.
CONTROL
Subjects randomized to the CONTROL group implanted with the Chronicle implantable hemodynamic monitoring (IHM) device, but the intracardiac diagnostic information was blinded to both the patient and the physician during the randomized period of the study. Subjects were managed conventionally with standard of care. Physicians and patients have access to the intracardiac data after the randomized period of the study is over, at 6 months.
Standard of Care
Surgical implantation of chronic ambulatory implantable hemodynamic monitoring (IHM) device and intracardiac pressure sensing lead, but physician and patient access to the intracardiac information provided by the device is restricted until the end of the randomized period of the study, at 6 months. Patients and patients heart failure are managed conventionally per standard of care.
Interventions
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Chronicle Implantable Hemodynamic Monitor
Surgical implantation of chronic ambulatory implantable hemodynamic monitoring (IHM) device and intracardiac pressure sensing lead. The implantable hemodynamic monitoring device captures intracardiac hemodynamic information about the patient including trended right ventricular (RV) and estimated pulmonary arterial (PA) pressures, heart rate and activity data. The IHM device does not provide therapy, but rather provides intracardiac diagnostic information about the patient which the physician can utilize to manage the patient and the patients heart failure.
Standard of Care
Surgical implantation of chronic ambulatory implantable hemodynamic monitoring (IHM) device and intracardiac pressure sensing lead, but physician and patient access to the intracardiac information provided by the device is restricted until the end of the randomized period of the study, at 6 months. Patients and patients heart failure are managed conventionally per standard of care.
Eligibility Criteria
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Inclusion Criteria
* Subject has been managed with standard medical therapy for heart failure (such as diuretic, angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blockers (ARB), and beta-blocker for at least 3 months prior to the baseline evaluation
* Subject must have at least one heart failure-related hospitalization or emergency department visit requiring intravenous treatment within 6 months prior to baseline evaluation
Exclusion Criteria
* Subjects with severe COPD or restrictive airway disease (recommended FEV1 less than or equal to 1 liter or 50% predicted)
* Subjects who are on continuous positive inotropic therapy
* Subjects with known atrial or ventricular septal defects
* Subjects with mechanical right heart valves
* Subjects with stenotic tricuspid or pulmonary valves
* Subjects with a presently implanted non-compatible pacemaker or ICD
* Subjects with cardiac resynchronization therapy which has not achieved optimal programming for more than 3 months
* Subjects with a major cardiovascular event within 3 months prior to baseline evaluation
* Subjects with a severe non-cardiac condition limiting 6 month survival
* Subjects with a primary diagnosis of pulmonary artery hypertension
* Subjects with serum creatinine greater than or equal to 3.5 mg/dL or on chronic renal dialysis
* Subjects enrolled in concurrent studies that may confound the results of this study
* Women who are pregnant or with child bearing potential and who are not on a reliable form of birth control
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Bourge, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Loma Linda University Medical Center
Loma Linda, California, United States
UCLA Medical Center
Los Angeles, California, United States
University of Southern California
Los Angeles, California, United States
University of Florida - Shands
Gainesville, Florida, United States
Crawford LongHospital
Atlanta, Georgia, United States
Prairie Heart Institute
Springfield, Illinois, United States
Parkview Memorial Hospital
Fort Wayne, Indiana, United States
New England Medical Center
Boston, Massachusetts, United States
St. Paul Heart
Saint Paul, Minnesota, United States
Mid America Heart Institute
Kansas City, Missouri, United States
Robert Wood Johnson Medical Center
New Brunswick, New Jersey, United States
Newark Beth Israel
Newark, New Jersey, United States
New York Presbyterian - Columbia
New York, New York, United States
Duke University
Chapel Hill, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Oklahoma Cardiovascular Associates
Oklahoma City, Oklahoma, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baptist Memorial Hospital
Germantown, Tennessee, United States
St. Thomas Hospital
Nashville, Tennessee, United States
St. Luke's Episcopal Hospital/Texas Heart
Houston, Texas, United States
LDS Hospital
Salt Lake City, Utah, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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References
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Zile MR, Adamson PB, Cho YK, Bennett TD, Bourge RC, Aaron MF, Aranda JM Jr, Abraham WT, Stevenson LW, Kueffer FJ. Hemodynamic factors associated with acute decompensated heart failure: part 1--insights into pathophysiology. J Card Fail. 2011 Apr;17(4):282-91. doi: 10.1016/j.cardfail.2011.01.010. Epub 2011 Feb 26.
Other Identifiers
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COMPASS-HF
Identifier Type: -
Identifier Source: org_study_id