Status:
COMPLETED
Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
COMPASS-HF was a prospective, two-arm, randomized (1:1), multi-center, parallel controlled study. The purpose of the randomized study was to test the safety of an implantable hemodynamic monitor (IHM)...
Detailed Description
COMPASS-HF was a prospective, two-arm, randomized (1:1), multi-center, parallel controlled study. The purpose of the randomized study was to test the safety of an implantable hemodynamic monitor (IHM)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
277 Patients enrolled
Trial Details
Trial ID
NCT00643279
Start Date
March 1 2003
End Date
April 1 2013
Last Update
December 22 2023
Active Locations (28)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States
2
Loma Linda University Medical Center
Loma Linda, California, United States
3
UCLA Medical Center
Los Angeles, California, United States
4
University of Southern California
Los Angeles, California, United States