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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial seems to be testing whether a wearable ECG device can estimate ejection fraction the same way an echocardiogram does — given my specific heart condition, could wearing this monitor provide useful information about my heart function, or would a traditional echo still be the more reliable option for managing my care right now?
2Since this study is comparing the wearable ECG readings against standard echocardiography results, would I still be getting a regular echo as part of this trial, and would those results be shared with you to guide my treatment?
3This trial is listed as 'Phase NA,' which often means it's a device validation or observational study rather than a treatment trial — does that mean there's no experimental therapy involved, and what, if any, are the actual risks of participating?
4Given that this trial covers a wide range of heart conditions including heart failure, cardiomyopathy, and valvular disease, how relevant is the data it's collecting to my specific diagnosis, and would participating give you any additional insights into how my heart is functioning?
5If the wearable device in this trial turns out to accurately assess ejection fraction severity, how might that change the way you monitor my condition over time compared to scheduling repeated echocardiograms?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Agreement of CorEFS Software EF Severity Categories Using Peerbridge COR™ ECG Data with ASE EF Severity Categories Established by Ultrasound Echocardiography
Timeframe: Through study completion, average of 9 months.