Peerbridge Health announces the successful completion of its prospective, multi-center, feasibility clinical trial to deliver AI-enabled ejection fraction (EF) on-demand using the Peerbridge CorTM, a patented 3-lead, 2-channel wireless ambulatory ECG (AECG) wearable device. The trial yielded positive results, advancing the remote diagnosis and monitoring of cardiovascular disease including heart failure.
Cor demonstrated 91% predictive accuracy measuring EF based on the American Society of Echocardiography (ASE) severity scale for left ventricular dysfunction. Researchers also found that an EF measurement can be calculated just nine minutes after device application.
Peerbridge Health’s CEO & President Chris Darland added, “We are pleased to share that the primary and three secondary endpoints were successfully met in our first on-demand EF from ECG clinical trial. These are major milestones for Peerbridge Health as we continue to develop innovative solutions that support earlier diagnosis and treatment for patients with heart failure and other chronic illnesses.”
“The Cor’s ability to quickly and accurately measure EF is a total game-changer within cardiology and beyond,” said Nicholas Skipitaris, MD, MBA, Western Regional Director, Cardiac Electrophysiology, Northwell Health. “This technology offers significant clinical value to heart failure and cardiac patients throughout their continuum of care, with improved monitoring and treatment of their conditions – whether they are in a clinic, hospital, or at home.”
More than 6.5 million Americans are currently managing a heart failure diagnosis, with close to 1 million new cases each year1. Heart failure is the leading cause of hospitalization for adults 65 and older in the US, with a 24% mortality rate after a heart failure hospitalization2. While echocardiogram measures EF, it must be performed in a clinic or hospital setting and presents challenges due to delays in scheduling, limited staffing resources, and higher costs. The Peerbridge Health platform offers a seamless remote monitoring option with less expense, reducing patient burden and enabling more frequent assessments.
“EF is a hugely important heart health metric that guides many of our patient treatment decisions. The Peerbridge Cor allows us to measure this metric in real time,” said Brian Kolski, MD, Director of Structural Heart Disease at Saint Joseph Hospital in Orange County. “This new technology challenges static EF measurements of the past, providing crucial insights to physicians more quickly, easily, and with less expense.”
The clinical trial included patients across three enrollment sites, including Lenox Hill Hospital, Northwell Health (NY), Orange County Heart Institute (CA), and HCA Research Institute at Los Robles (CA). Patient ages ranged from 34-90 years and included high-risk patients with co-morbidities like atrial fibrillation (AFib), cardiomyopathy, coronary artery disease (CAD), and amyloidosis. Patient EF measurements ranged from 15-70%.
To build on this research, Peerbridge Health plans to launch a prospective, multi-center, pivotal trial in the fall, pending IRB approval.
1Emory Healthcare. (2019). Retrieved from https://www.emoryhealthcare.org/centers-programs/heart-vascular-center/wellness/heart-failure-statistics.html
2Circulation. (2012). Retrieved from https://www.ahajournals.org/doi/full/10.1161/circulationaha.112.125435