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

Peerbridge Health, Inc · NCT06699056

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
2000
US sites recruiting
8
Study start
November 21, 2024
Record last updated
June 1, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: 15-minutes of sitting during COR ECG Acquistion

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Orange County Heart Institute

    Orange, CA 92868

    Site contact: Brian Kolski, MD · (714) 564-3300 · bkolskimd@gmail.com

  • Peerbridge Health

    Pasadena, CA 91107

    Site contact: Sandeep Gulati, PhD · 877-960-0332 · s.gulati@peerbridgehealth.com

  • Henry Ford Hospital

    Detroit, MI 48202

    Site contact: Sacchin Parikh, MD · 313-916-2721 · Sparikh2@hfhs.org

  • Hackensack University Medical Center

    Hackensack, NJ 07601

    Site contact: Sameer Jamal, MD · 551-996-5870 · sameer.jamal@hmhn.org

  • Mount Sinai Hospital

    New York, NY 10019

    Site contact: Joslin J Plathottam, MBBS, MPH · 631-750-6345 · JoslinJose.Plathottam@mountsinai.org

  • Moses H. Cone Memorial Hospital

    Greensboro, NC 27401

    Site contact: Jennifer Knapp · 336-832-3795 · Jennifer.knapp@conehealth.com

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, TX 78705

    Site contact: Andrea Natale, MD · 512-807-3150 · tcarfan@gmail.com

  • South Heart Clinic

    Weslaco, TX 78596

    Site contact: Frank Mazzola, MD · 877-426-7457 · frank.mazzola@southheartclinic.org

Study contacts (from the official record)

  • Sandeep Gulati, PhD · 8182162958 · s.gulati@peerbridgehealth.com
  • Chris Darland, MBA · 814-572-7138 · c.darland@peerbridgehealth.com
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AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity… (NCT06699056) | Bored Studies