N/A
N=274
Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00643279 ↗Enrolled (actual)
274
Serious AEs
62.0%
Results posted
Sep 2019
Primary outcome: Primary: Safety as Measured by the Percentage of Participants Free From System Related Complications Through 6 Months. — 277 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Chronicle Implantable Hemodynamic Monitor (Device); Standard of Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Jun 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety as Measured by the Percentage of Participants Free From System Related Complications Through 6 Months. |
277 | — |
| PRIMARY Safety as Measured by the Percentage of Participants Free From Implantable Hemodynamic Monitor Pressure Related Sensor Lead Failures Through 6 Months. |
274 | — |
| PRIMARY Rate of Heart Failure-related Hospital Equivalents. |
0.63; 0.81 | — |
| SECONDARY Health Care Utilization |
218; 255 | — |
| SECONDARY Days Hospitalization Free |
170.8; 172.7 | — |
| SECONDARY Clinical Composite Response of Either "Worsened", "Improved", or "Unchanged" |
56; 48; 50; 66; 28; 26 | — |
| SECONDARY Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire |
-12.5; -8.5 | — |
| SECONDARY New York Heart Association (NYHA) Class |
7; 11; 39; 31; 61; 70 | — |
| SECONDARY Distance Walked During a Six Minute Hall Walk |
6.2; -8.2 | — |
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) and pressure sensor lead. The premise of this study was to compare the effectiveness of a novel heart failure management strategy based on information obtained from the IHM system in reducing heart failure morbidity compared to a strategy based on standard medical care alone.
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
Data sourced from ClinicalTrials.gov (NCT00643279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.