Sensible Medical Innovations Lung fLuid Status Monitor Allows rEducing Readmission Rate of Heart Failure Patients (SMILE)—A Randomized Controlled Study

ABSTRACT Heart failure is the leading cause of hospitalization, and reducing potentially preventable readmissions has been a major goal for many health care organizations. The potential for penalties from the Centers for Medicare & Medicaid Services for poor performance has heightened concern. An implantable pulmonary artery pressure sensor has been shown to reduce risk of rehospitalization for heart failure, but the invasive nature, expense, and variable payor coverage have blunted adoption. The Sensible Medical Innovations Lung fLuid Status Monitor Allows rEducing Readmission Rate of Heart Failure Patients (SMIILE) study is a prospective, randomized, controlled, multicenter study of patients hospitalized with a diagnosis of acute decompensated heart failure. The intervention of readings from a wearable vest that measures lung fluid using dielectric sensing will be compared with standard of care. The primary efficacy endpoint is the rate of heart failure readmissions during the follow-up period. The stud...