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

NCT00643279 | Completed Results DMC

• 1 other identifier: COMPASS-HF
• Study Type: interventional
• Target: 277
• Locations: 1 country
• Sites: 28

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) 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.

Conditions

Heart Failure

Keywords

implantable hemodynamic monitor; Intracardiac pressures

Outcome Measures

Primary Outcomes (3)

• Safety as Measured by the Percentage of Participants Free From System Related Complications Through 6 Months.

  A Chronicle IHM system-related complication was defined as any system-related adverse event that occurred during the clinical investigation which is (1) treated with invasive means (including intravenous drug therapy), (2) results in death, (3) results in the explant of any Chronicle IHM component, and/or (4) causes permanent loss of significant function of the implanted system. Safety is defined as ≥ 80% of participants experiencing freedom from device related complications through 6 months.

  Within 6 months post-implant

• Safety as Measured by the Percentage of Participants Free From Implantable Hemodynamic Monitor Pressure Related Sensor Lead Failures Through 6 Months.

  A pressure sensor failure was defined as a recognizable, abrupt, non-physiologic shift in pressure parameters. Safety is defined as ≥ 90% of participants free from pressure sensor lead failure through 6 months.

  Within 6 months post-implant

• Rate of Heart Failure-related Hospital Equivalents.

  Hospital equivalents (HE) were defined to include the following events: 1. Heart failure-related hospital admissions for 24 hours or longer 2. Heart failure-related emergency department visits and necessitates invasive treatment (e.g. IV diuretic administration). 3. Heart failure-related urgent visits and necessitates invasive treatment (e.g. IV diuretic administration).

  6 Months post-implant

Secondary Outcomes (6)

• Health Care Utilization

  6 Months post-implant

• Days Hospitalization Free

  6 Months post-implant

• Clinical Composite Response of Either "Worsened", "Improved", or "Unchanged"

  6 Months post-implant

• Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire

  6 Months post-implant

• New York Heart Association (NYHA) Class

  6 Months post-implant

Study Arms (2)

CHRONICLE

EXPERIMENTAL

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.

Device: Chronicle Implantable Hemodynamic Monitor

CONTROL

PLACEBO COMPARATOR

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.

Other: Standard of Care

Interventions

Chronicle Implantable Hemodynamic Monitor DEVICE

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.

CHRONICLE

Standard of Care OTHER

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.

CONTROL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (28)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Location

Loma Linda University Medical Center

Loma Linda, California, United States

Location

UCLA Medical Center

Los Angeles, California, United States

Location

University of Southern California

Los Angeles, California, United States

Location

University of Florida - Shands

Gainesville, Florida, United States

Location

Crawford LongHospital

Atlanta, Georgia, United States

Location

Prairie Heart Institute

Springfield, Illinois, United States

Location

Parkview Memorial Hospital

Fort Wayne, Indiana, United States

Location

New England Medical Center

Boston, Massachusetts, United States

Location

St. Paul Heart

Saint Paul, Minnesota, United States

Location

Mid America Heart Institute

Kansas City, Missouri, United States

Location

Robert Wood Johnson Medical Center

New Brunswick, New Jersey, United States

Location

Newark Beth Israel

Newark, New Jersey, United States

Location

New York Presbyterian - Columbia

New York, New York, United States

Location

Duke University

Chapel Hill, North Carolina, United States

Location

University of Cincinnati

Cincinnati, Ohio, United States

Location

The Ohio State University

Columbus, Ohio, United States

Location

Oklahoma Cardiovascular Associates

Oklahoma City, Oklahoma, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Location

Medical University of South Carolina

Charleston, South Carolina, United States

Location

Baptist Memorial Hospital

Germantown, Tennessee, United States

Location

St. Thomas Hospital

Nashville, Tennessee, United States

Location

St. Luke's Episcopal Hospital/Texas Heart

Houston, Texas, United States

Location

LDS Hospital

Salt Lake City, Utah, United States

Location

University of Washington Medical Center

Seattle, Washington, United States

Location

Related Publications (1)

• 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.

  PMID: 21440865 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dana Wigert
• Organization: Medtronic

dana.wigert@medtronic.com

763-526-2802

Study Officials

• Robert Bourge, MD

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 26, 2008
• Study Start: March 1, 2003
• Primary Completion: June 1, 2005
• Study Completion: April 1, 2013
• Last Updated: December 22, 2023
• Results First Posted: September 16, 2019

Record last verified: 2023-12

Locations

US (28)