AI-based assessment of heart function using ECG wearable monitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Orange County Heart Institute
  Orange, California, United States Recruiting
• Peerbridge Health
  Pasadena, California, United States 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

Study contacts

• Principal investigator: Andrea Natale, MD — Texas Cardiac Arrhythmia Research Foundation
• Study coordinator: Sandeep Gulati, PhD
• Email: s.gulati@peerbridgehealth.com
• Phone: 8182162958

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.