
Cardiosense Begins Enrollment in Nationwide Heart Failure Study
Cardiosense, a leading digital health company focused on developing a non-invasive monitoring platform for early heart disease detection, has initiated patient enrollment in its nationwide clinical study, SEISMIC-HF I. This study aims to refine and validate algorithms for assessing intracardiac filling pressure, a crucial early indicator of acute heart failure decompensation. These algorithms harness data collected by CardioTag, Cardiosense’s non-invasive patch designed to measure key cardiac function parameters.
The standard of care for heart failure relies heavily on clinician assessment of symptoms and physical examination, which are insufficient for identifying asymptomatic patients. Currently, only one US FDA-approved device exists for outpatient hemodynamic monitoring, the CardioMEM’s HF system, but it requires an internally implanted sensor in the distal pulmonary artery and is underutilized due to cost and patient reluctance to the invasive procedure. Cardiosense is developing a wearable device called CardioTag, which captures seismocardiogram, electrocardiogram, and photoplethysmogram signals. These signals are analyzed using advanced signal processing and machine learning techniques to estimate hemodynamic parameters, including changes in intracardiac filling pressure (PCWP), cardiac output, contractility, and blood pressure. The Cardiosense Monitoring Platform has received FDA Breakthrough Device Designation, focusing on estimating PCWP in HF patients with reduced ejection fraction. This innovation offers a noninvasive alternative for monitoring patients, potentially addressing a critical unmet need in heart failure care.
Cardiosense conducted a proof-of-concept study to demonstrate the capabilities of the CardioTag device in estimating changes in intracardiac filling pressure (PCWP) using signal processing and machine learning techniques. The study involved 20 heart failure patients who wore an earlier version of the CardioTag during right heart catheterization procedures at the University of California-San Francisco. The signals collected by the CardioTag during these procedures were used to estimate changes in PCWP. A population regression model was developed, showing that the CardioTag’s signals could accurately estimate changes in PCWP. This proof-of-concept study demonstrates the device’s potential to track PCWP changes in heart failure patients effectively.
Heart failure currently affects over 6 million individuals in the United States, and it is projected to impose an annual healthcare cost of more than $70 billion by 2030. Traditionally, assessing elevated intracardiac filling pressures has required invasive methods, which limit their applicability to a broader patient population. Dr. Anjan Tibrewala of Northwestern Medicine’s Bluhm Cardiovascular Institute noted, “Cardiosense’s technology holds the potential to be a game-changing solution for remotely monitoring heart failure patients.”