NCT06699056 AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor
| NCT ID | NCT06699056 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peerbridge Health, Inc |
| Condition | Ventricular Ejection Fraction |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2024-11-21 |
| Primary Completion | 2027-11-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2024-11-21 with a primary completion date of 2027-11-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Andrea Natale, MD
PRINCIPAL INVESTIGATOR
Texas Cardiac Arrhythmia Research Foundation
Frequently Asked Questions
Who can join the NCT06699056 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ventricular Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06699056 currently recruiting?
Yes, NCT06699056 is actively recruiting participants. Contact the research team at s.gulati@peerbridgehealth.com for enrollment information.
Where is the NCT06699056 trial being conducted?
This trial is being conducted at Orange, United States, Pasadena, United States, Detroit, United States, Hackensack, United States and 4 additional locations.
Who is sponsoring the NCT06699056 clinical trial?
NCT06699056 is sponsored by Peerbridge Health, Inc. The principal investigator is Andrea Natale, MD at Texas Cardiac Arrhythmia Research Foundation. The trial plans to enroll 2,000 participants.