Trial is first of its kind to measure EF
severity direct-from-ECG
NEW
YORK, July 24, 2024 /PRNewswire/ -- Peerbridge
Health today announced the beginning of enrollment for its Ejection
Fraction AI-enabled Clinical Trial (EF-ACT) pivotal trial to
determine Left Ventricular Ejection Fraction (LVEF) severity
directly from its AI-enabled Peerbridge Cor™ remote wearable
electrocardiogram (ECG) device. This will enable on-demand
assessments of EF Severity on the American Society of
Echocardiography scale and will be available anytime in all
settings – in clinic and at home.
Ejection Fraction Severity categories help clinicians assess the
severity of heart dysfunction, guiding treatment decisions and
prognostic evaluations. The Ejection Fraction (EF) severity
categories on the American Society of Echocardiography (ASE) scale
are defined based on the percentage of blood that the left
ventricle pumps out with each contraction.
The trial, whose announcement comes following in-depth
discussions with leading cardiology experts and the Food and Drug
Administration, will involve approximately 1,000 patients across
multiple trial centers, including Northwell Health, Hackensack
Meridian Health, Mount Sinai Health System, LeBauer-Brodie Center
for Cardiovascular Research at Cone Health and Orange County Heart
Institute in California. This
pivotal trial comes on the heels of a successful feasibility
trial in 2023.
"This is the first pivotal trial to study direct-from-ECG
ejection fraction (EF) severity at this level of fidelity," said
Peerbridge Health CEO and President Chris
Darland. "The findings of this trial could have a profound
effect on access and affordability of cardiac care."
Echocardiograms are the most common measurement tool for
ejection fraction, but they must be performed in a clinic or
hospital setting. This can pose challenges due to delays in
scheduling, limited staffing resources, lack of access, and higher
costs. The Peerbridge Health platform offers a seamless remote
monitoring option that is less expensive, reducing patient burden
and enabling more frequent assessments. Coupled with rhythm
changes, direct-from-COR EF Severity would add valuable context for
clinical decision-making, enhancing intervention adjustments.
"Peerbridge's EF technology addresses a critical gap in remote
healthcare by providing a rapid, convenient, noninvasive, and
cost-effective method to better understand a patient's cardiac
status," said Nicolas Skipitaris,
MD, Chairman of Cardiovascular Medicine at Northwell Health's
Westchester Hospitals. "Early and accurate remote detection of
potential cardiac dysfunction allows us to intervene more quickly
and more effectively, improving patient outcomes at a fraction of
the cost."
Development of the Peerbridge Health Advanced Diagnostics
platform began in Spring 2023 and Ejection Fraction Severity is the
first of three AI-enabled pivotal trials for Software-as-a-Medical
Device (SaMD), with Heart Failure Detection and Sleep Apnea
Diagnosis to follow.
"We're very grateful to our clinical partners and are focused on
continuing to deliver innovation to care providers across the
country," Darland added. "Our goal remains to reach the
millions of aging patients who don't have the luxury of time or
money to proactively see a cardiologist to avoid a losing battle
with heart disease. The team at Peerbridge takes this
responsibility seriously. I am confident that our technology will
provide meaningful impact in the near- and long-term."
About Peerbridge Health
Peerbridge Health is
revolutionizing cardiac care as the first company to bring the
quality and accuracy of hospital-grade cardiac diagnostics and
monitoring to the home. The company's AI-enabled device,
Peerbridge Cor™, includes a three-lead, patented AECG
wearable device that features a design based on the
Einthoven Triangle. The Peerbridge platform
leverages ECG to diagnose and monitor the most
important elements of cardiac care at a lower cost than ever
before. Data captured provides actionable insights that promote
early invention, reduce hospital visits and saves lives. For more,
go to peerbridgehealth.com or visit our
LinkedIn page.
Media Contact:
Kim Mohr
Amendola Communications for Peerbridge Health
949-322-3733; kmohr@acmarketingpr.com
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SOURCE Peerbridge Health