Heart Failure Clinical Trial

Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)

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.

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Full 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) 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.

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events were identified; procedure related adverse events were followed through to resolution before the subject were withdrawn from the study.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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

277

Study ID:

NCT00643279

Recruitment Status:

Completed

Sponsor:

Medtronic Cardiac Rhythm and Heart Failure

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There is 1 Location for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

277

Study ID:

NCT00643279

Recruitment Status:

Completed

Sponsor:


Medtronic Cardiac Rhythm and Heart Failure

How clear is this clinincal trial information?

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