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AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor

AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Using COR ECG Wearable Monitor

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

Inclusion Criteria:

* Age ≥ 18 years
* Able and eligible to wear a Holter monitor

Exclusion Criteria:

* Receiving mechanical respiratory or circulatory support, or renal support therapy, at the time of screening or during Visit #1
* Any condition that, in the investigator's opinion, could interfere with compliance with the study protocol or pose a safety risk to the participant
* History of poor tolerance or severe skin reactions to ECG adhesive materials

About the study

This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF) severity categories based on the American Society of Echocardiography's (ASE) 4-category scale. The software analyzes continuous ECG waveform data acquired by the FDA-cleared Peerbridge COR® ECG Wearable Monitor, an ambulatory patch device designed for use during daily activities. The AI software assists clinicians in cardiac evaluations by estimating EF severity, which reflects how well the heart pumps blood.

In this study, EF severity determination will be made using 5-minute ECG recordings collected during a 15-minute resting period with participants seated upright. The results will be compared to EF severity obtained from an FDA-cleared, non-contrast transthoracic echocardiogram (TTE) predicate device. This comparison aims to validate the accuracy of the AI software.

What is being tested

• 15-minutes of sitting during COR ECG Acquistion (device)

Sponsor: Peerbridge Health, Inc · Participants: 2,000 · Started: Nov 21, 2024

Contact the study team

• Sandeep Gulati, PhD · Phone: 8182162958
• Chris Darland, MBA · Phone: 814-572-7138

Official record on ClinicalTrials.gov — NCT06699056

Locations in the U.S.

Conditions

• Left Ventricular Dysfunction
• Arrhythmia
• Heart Failure
• Heart Valve Diseases
• Myocardial Ischemia
• Cardiotoxicity
• Heart Attack
• Dilated Cardiomyopathy

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.