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

Summary

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.

Conditions

• Ventricular Ejection Fraction
• LVF
• LV Dysfunction
• Atrial Enlargement
• Conduction Defect
• Heart Failure
• Valvular Heart Disease
• Ischemic Heart Disease
• Cardiotoxicity
• Myocardial Infarction
• Dilated Cardiomyopathy
• HFrEF - Heart Failure With Reduced Ejection Fraction
• HFpEF - Heart Failure With Preserved Ejection Fraction
• Syncope
• Remodeling, Cardiac

Interventions

DEVICE

15-minutes of sitting during COR ECG Acquistion

Participants will follow a standardized protocol during a 15-minute seated session using the Peerbridge COR™ device. Participants will sit comfortably in an upright chair with a straight back; armrests are optional. Their feet must remain flat on the floor with legs uncrossed to ensure unobstructed blood flow and a stable posture. Arms should be relaxed and placed in their lap, on a flat surface (e.g., table), or on the armrest, ensuring they are not tensed or elevated. Participants will maintain a straight back with relaxed shoulders throughout the session. To begin, participants will press the Event Button on the Peerbridge COR™ mobile device, marking the start of the session. They will remain seated in this position for 15 minutes. At the end of the session, participants will press the Event Button again to mark the conclusion of the seated event. This protocol ensures consistent data collection across all participants.

Sponsors & Collaborators

• Peerbridge Health, Inc

  lead INDUSTRY

Principal Investigators

• Andrea Natale, MD · Texas Cardiac Arrhythmia Research Foundation

• Johanna P Contreras, MD · MOUNT SINAI HOSPITAL

• Sachin Parikh, MD · Henry Ford Hospital

• Brian Kolski, MD · Orange County Heart Institute

• Daniel Bensimhon, MD · Moses H. Cone Memorial Hospital

• Sandeep Gulati, PhD · Peerbridge Health, Inc

• Frank Mazzola, MD · South Heart Clinic

• Sameer Jamal, MD · Hackensack Meridian Health

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-11-21

Primary Completion

2025-09-30

Completion

2025-09-30

FDA Device

Yes

Countries

• United States

Study Locations