At a glance
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Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)
In Brief
A clinical study evaluating Chronicle Implantable Hemodynamic Monitor and Standard of Care for Heart Failure. Completed, enrolled 277 participants across 28 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.