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

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ClinicalTrials.gov Identifier: NCT00643279
Recruitment Status : Unknown
Verified January 2013 by Medtronic Cardiac Rhythm and Heart Failure.
Recruitment status was:  Active, not recruiting
First Posted : March 26, 2008
Last Update Posted : February 1, 2013
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Brief Summary:
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 or disease Intervention/treatment Phase
Heart Failure Device: Chronicle Implantable Hemodynamic Monitor Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)
Study Start Date : March 2003
Actual Primary Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources


Intervention Details:
    Device: Chronicle Implantable Hemodynamic Monitor
    Surgical implantation of chronic ambulatory hemodynamic monitoring device and intracardiac lead.


Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Secondary Outcome Measures :
  1. Health Care Utilization [ Time Frame: 6 Months post-implant ]
  2. Subject survival and days alive out of the hospital [ Time Frame: 6 Months post-implant ]
  3. Rate of adverse events [ Time Frame: 6 Months post-implant ]
  4. Retrospective analysis of the predictive value of pressure change in the control group [ Time Frame: 6 Months post-implant ]
  5. Clinical composite response of either "worsened", "improved", or "unchanged" [ Time Frame: 6 Months post-implant ]
  6. Quality of Life measured by the Minnesota Living with Heart Failure questionnaire [ Time Frame: 6 Months post-implant ]
  7. New York Heart Association (NYHA) Class [ Time Frame: 6 Months post-implant ]
  8. Distance walked during a six minute hall walk [ Time Frame: 6 Months post-implant ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643279


  Show 28 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
Study Chair: COMPASS-HF Team Medtronic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT00643279     History of Changes
Other Study ID Numbers: COMPASS-HF
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: February 1, 2013
Last Verified: January 2013

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
implantable hemodynamic monitor
Intracardiac pressures

Additional relevant MeSH terms:
Heart Failure
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases