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

Sponsored by:	Medtronic Cardiac Rhythm Disease Management
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00643279

Purpose

The purpose of this clinical research study is to evaluate the safety of an investigational implantable hemodynamic monitor (IHM). The IHM is implanted surgically under the skin in the upper chest area and records the force with which the heart pumps blood (heart pressures). This study will also determine how doctors use the information related to heart pressures in the management of heart failure.

Condition	Intervention	Phase
Heart Failure	Device: Chronicle Implantable Hemodynamic Monitor (IHM)	Phase II

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:

To evaluate the safety of the implantable hemodynamic monitor by demonstrating freedom from system-related complications greater than or equal to 80% at 6 months. [ Time Frame: Within 6 months post-implant ] [ Designated as safety issue: Yes ]
To evaluate the safety of the implantable hemodynamic monitor by demonstrating freedom from pressure related sensor lead failure greater than or equal to 90% at 6 months. [ Time Frame: Within 6 months post-implant ] [ Designated as safety issue: Yes ]
To assess the efficacy of designated treatment strategies by demonstrating a reduction in the rate of all heart failure events in the treatment group compared to the control group. [ Time Frame: 6 Months post-implant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Health Care Utilization [ Time Frame: 6 Months post-implant ] [ Designated as safety issue: No ]
Subject survival and days alive out of the hospital [ Time Frame: 6 Months post-implant ] [ Designated as safety issue: No ]
Rate of adverse events [ Time Frame: 6 Months post-implant ] [ Designated as safety issue: No ]
Retrospective analysis of the predictive value of pressure change in the control group [ Time Frame: 6 Months post-implant ] [ Designated as safety issue: No ]
Clinical composite response of either "worsened", "improved", or "unchanged" [ Time Frame: 6 Months post-implant ] [ Designated as safety issue: No ]
Quality of Life measured by the Minnesota Living with Heart Failure questionnaire [ Time Frame: 6 Months post-implant ] [ Designated as safety issue: No ]
New York Heart Association (NYHA) Class [ Time Frame: 6 Months post-implant ] [ Designated as safety issue: No ]
Distance walked during a six minute hall walk [ Time Frame: 6 Months post-implant ] [ Designated as safety issue: No ]

Enrollment:	274
Study Start Date:	March 2003
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Intervention Details:

Surgical implantation of chronic ambulatory hemodynamic monitoring device and intracardiac lead.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643279

Show 28 Study Locations

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

Investigators

Study Chair:

COMPASS-HF Team

Medtronic

More Information

No publications provided

Responsible Party:	Medtronic CRDM ( CRDM NT&D Clinical - Amy Roettger )
Study ID Numbers:	COMPASS-HF
Study First Received:	February 29, 2008
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00643279 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medtronic Cardiac Rhythm Disease Management:

implantable hemodynamic monitor
Intracardiac pressures

Study placed in the following topic categories:

Signs and Symptoms
Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Signs and Symptoms
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009