AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor
Public ClinicalTrials.gov record NCT06699056. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Using COR ECG Wearable Monitor
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06699056
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 2,000 participants
Conditions and interventions
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 (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 20, 2024
- Primary completion
- Nov 14, 2027
- Completion
- Nov 14, 2027
- Last update posted
- May 31, 2026
2024 – 2027
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Orange County Heart Institute | Orange | California | 92868 | Recruiting |
| Peerbridge Health | Pasadena | California | 91107 | Recruiting |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Recruiting |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | Recruiting |
| Mount Sinai Hospital | New York | New York | 10019 | Recruiting |
| Moses H. Cone Memorial Hospital | Greensboro | North Carolina | 27401 | Recruiting |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | Recruiting |
| South Heart Clinic | Weslaco | Texas | 78596 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06699056, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 31, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06699056 live on ClinicalTrials.gov.