- Peerbridge Health begins enrollment for its EF-ACT pivotal trial to evaluate Left Ventricular Ejection Fraction (LVEF) severity using the Peerbridge Cor™ AI-enabled remote ECG device.
- The trial aims to provide on-demand EF severity assessments based on the American Society of Echocardiography scale, accessible in both clinical and home settings.
- Approximately 1,000 patients will participate across multiple trial centers, including Northwell Health, Hackensack Meridian Health, and Mount Sinai Health System.
- This pivotal trial follows a successful feasibility study conducted in 2023.
- The Peerbridge Cor™ device offers a cost-effective, remote alternative to traditional echocardiograms, reducing patient burden and improving access to frequent assessments.
- The trial represents the first of three AI-enabled pivotal trials for Software-as-a-Medical Device (SaMD), with future trials focusing on Heart Failure Detection and Sleep Apnea Diagnosis.
- The technology aims to enhance accessibility and affordability of cardiac care, addressing gaps in remote healthcare.
Main AI News:
Peerbridge Health has officially launched the enrollment phase for its pivotal Ejection Fraction AI-Enabled Clinical Trial (EF-ACT). This groundbreaking trial aims to assess Left Ventricular Ejection Fraction (LVEF) severity using the AI-powered Peerbridge Cor™ remote wearable electrocardiogram (ECG) device. Designed for on-demand evaluation, this technology offers real-time EF severity assessments based on the American Society of Echocardiography scale, accessible both in clinical settings and at home.
Ejection Fraction severity categories are crucial for diagnosing heart dysfunction, directing treatment strategies, and predicting patient outcomes. These categories are determined by the percentage of blood ejected from the left ventricle per heartbeat, a critical measure in cardiac care.
Following extensive consultations with cardiology experts and the Food and Drug Administration, the trial will engage around 1,000 patients at renowned institutions such as Northwell Health, Hackensack Meridian Health, Mount Sinai Health System, LeBauer-Brodie Center for Cardiovascular Research at Cone Health, and the Orange County Heart Institute in California. This pivotal trial builds upon the success of a 2023 feasibility study.
“This is the inaugural pivotal trial evaluating direct-from-ECG ejection fraction (EF) severity with such precision,” stated Chris Darland, CEO and President of Peerbridge Health. “The trial’s outcomes could significantly enhance the accessibility and affordability of cardiac care.”
Currently, echocardiograms remain the standard method for measuring ejection fraction, typically requiring clinical or hospital visits. These procedures can lead to scheduling delays, resource constraints, and higher costs. The Peerbridge Health platform provides a cost-effective, remote monitoring alternative that alleviates patient burden and facilitates more frequent evaluations. The integration of EF Severity with rhythm monitoring offers added value for clinical decision-making, improving intervention strategies.
Nicolas Skipitaris, MD, Chairman of Cardiovascular Medicine at Northwell Health’s Westchester Hospitals, noted, “Peerbridge’s EF technology bridges a critical gap in remote healthcare by offering a quick, convenient, non-invasive, and affordable way to assess cardiac health. Early, precise remote detection of potential cardiac issues enables timely and effective interventions, ultimately enhancing patient outcomes while reducing costs.”
Initiated in Spring 2023, the development of Peerbridge Health’s Advanced Diagnostics platform includes the EF Severity trial as the first of three AI-enabled pivotal trials for Software-as-a-Medical Device (SaMD). Upcoming trials will focus on Heart Failure Detection and Sleep Apnea Diagnosis.
“We are deeply appreciative of our clinical partners and committed to advancing innovation for healthcare providers nationwide,” Darland concluded. “Our mission is to reach millions of aging patients who lack the resources or time for regular cardiology consultations, offering them a crucial advantage in managing heart disease. Our team at Peerbridge is dedicated to making a substantial impact in both the near and distant future.”
Conclusion:
Peerbridge Health’s launch of the EF-ACT trial represents a significant advancement in remote cardiac monitoring. By leveraging AI to provide real-time, on-demand assessments of ejection fraction severity, the company addresses key challenges associated with traditional echocardiograms, such as cost and accessibility. This innovation could transform how cardiac care is delivered, offering more frequent and convenient evaluations while potentially reducing overall healthcare costs. The success of this trial may set a precedent for future AI-driven medical devices and trials, underscoring the growing importance of technology in enhancing patient care and operational efficiency in healthcare settings.
