Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)
Heart Failure
About this trial
This is an interventional diagnostic trial for Heart Failure focused on measuring implantable hemodynamic monitor, Intracardiac pressures
Eligibility Criteria
Inclusion Criteria:
- Subjects with heart failure classified as New York Heart Association (NYHA) Class III and IV
- 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 who are likely to be transplanted within 6 months from randomization or will remain hospitalized until transplantation
- 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
Sites / Locations
- University of Alabama at Birmingham
- Loma Linda University Medical Center
- UCLA Medical Center
- University of Southern California
- University of Florida - Shands
- Crawford LongHospital
- Prairie Heart Institute
- Parkview Memorial Hospital
- New England Medical Center
- St. Paul Heart
- Mid America Heart Institute
- Robert Wood Johnson Medical Center
- Newark Beth Israel
- New York Presbyterian - Columbia
- Duke University
- University of Cincinnati
- The Ohio State University
- Oklahoma Cardiovascular Associates
- University of Oklahoma
- Hospital of the University of Pennsylvania
- Temple University Hospital
- University of Pittsburgh
- Medical University of South Carolina
- Baptist Memorial Hospital
- St. Thomas Hospital
- St. Luke's Episcopal Hospital/Texas Heart
- LDS Hospital
- University of Washington Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
CHRONICLE
CONTROL
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.
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.