Study of the Acorai Heart Monitor Device to Predict Outcomes in Patients Discharged After Acute Decompensated Heart Failure Treatment

What this Trial Is About

Researchers are evaluating the Acorai Heart Monitor, a handheld device designed to non-invasively measure pressures inside the heart in patients with heart failure. This observational study aims to assess the feasibility of using the Acorai device to predict survival, death, or major adverse cardiac events in patients who have been hospitalized with acute decompensated heart failure and are awaiting discharge home. The need for such a tool arises because current intracardiac pressure measurements require invasive right heart catheterization, which carries risks to patients. The Acorai Heart Monitor is an extended smartphone case equipped with various sensors that detect low-frequency sound and seismic signals related to intracardiac pressure. During the study, patients will have the device placed on their chest for five minutes while lying down, along with a small smart wristwatch to collect data. The study is single-arm, non-randomized, and non-significant risk, focusing on collecting non-invasive cardiac output measurements to evaluate the Acorai systems ability to predict outcomes. Participants will be patients recently hospitalized for decompensated heart failure who have received intravenous diuretic therapy and are medically fit for discharge. Researchers will monitor and assess intracardiac pressure data collected by the Acorai device and compare it with clinical outcomes over one year, including survival and hospital readmission. The primary outcome is the feasibility of predicting survival and hospitalization at one year. Secondary outcomes include predicting major adverse cardiac events and identifying which measurements best predict prognosis. The study is expected to last at least one year for each participant.

A Prospective, Observational, Single Centre Study to Assess the Feasibility of the Data Harvested by the Acorai Intracardiac Pressure Monitoring (ICPM) System in Predicting Prognosis in Patients Discharged From Hospital After Treatment for Acute Decompensated Heart Failure