AI-based assessment of heart function using ECG wearable monitors
AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Using COR ECG Wearable Monitor
This study tests if a new AI tool using a wearable heart monitor can accurately check heart function in people with heart failure compared to traditional heart scans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peerbridge Health, Inc Industry-sponsored |
| Locations | 8 sites (Orange, California and 7 other locations) |
| Trial ID | NCT06699056 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the accuracy of an AI software designed to assess ejection fraction (EF) severity using continuous ECG data from the Peerbridge COR® ECG Wearable Monitor. Participants will wear the device during a 15-minute resting period, and the AI's EF estimates will be compared to results from a standard echocardiogram. The goal is to provide a low-cost, accessible alternative for monitoring heart function, particularly in patients with heart failure. This approach aims to improve the accuracy and convenience of cardiac evaluations in everyday settings.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who can wear a Holter monitor and are not receiving mechanical or renal support.
Not a fit: Patients requiring mechanical respiratory or circulatory support, or those with severe skin reactions to ECG adhesives, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable more accessible and accurate monitoring of heart function for patients with heart failure.
How similar studies have performed: Previous studies have shown promising results with AI-enabled ECG analysis for estimating ejection fraction, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Orange, California and 7 other locations
- Orange County Heart Institute — Orange, California, United States (Recruiting)
- Peerbridge Health — Melbourne, Florida, United States (Not_yet_recruiting)
- Henry Ford Hospital — Detroit, Michigan, United States (Recruiting)
- Hackensack University Medical Center — Hackensack, New Jersey, United States (Recruiting)
- Mount Sinai Hospital — New York, New York, United States (Recruiting)
- Moses H. Cone Memorial Hospital — Greensboro, North Carolina, United States (Recruiting)
- Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States (Recruiting)
- South Heart Clinic — Weslaco, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Andrea Natale, MD — Texas Cardiac Arrhythmia Research Foundation
- Study coordinator: Sandeep Gulati, PhD
- Email: s.gulati@peerbridgehealth.com
- Phone: 8182162958
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.