Overview

This trial is active, not recruiting.

Condition heart failure
Treatment chronicle implantable hemodynamic monitor
Phase phase 2
Sponsor Medtronic Cardiac Rhythm Disease Management
Start date March 2003
End date June 2005
Trial size 274 participants
Trial identifier NCT00643279, COMPASS-HF

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose diagnostic

Primary Outcomes

Measure
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
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
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 Outcomes

Measure
Health Care Utilization
time frame: 6 Months post-implant
Subject survival and days alive out of the hospital
time frame: 6 Months post-implant
Rate of adverse events
time frame: 6 Months post-implant
Retrospective analysis of the predictive value of pressure change in the control group
time frame: 6 Months post-implant
Clinical composite response of either "worsened", "improved", or "unchanged"
time frame: 6 Months post-implant
Quality of Life measured by the Minnesota Living with Heart Failure questionnaire
time frame: 6 Months post-implant
New York Heart Association (NYHA) Class
time frame: 6 Months post-implant
Distance walked during a six minute hall walk
time frame: 6 Months post-implant

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Medtronic Cardiac Rhythm Disease Management.