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NCT06699056 · ClinicalTrials.gov registry record
AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor
A clinical trial of Heart Failure and Myocardial Infarction, sponsored by Peerbridge Health.
- Recruiting
- Registry status
- 1,500
- Enrollment target
- 8
- Study locations
NCT06699056: Recruiting study of Heart Failure and Myocardial Infarction, sponsored by Peerbridge Health.
NCT06699056 is a study of Heart Failure and Myocardial Infarction that is actively recruiting participants, run by Peerbridge Health. The registered enrollment target is 1,500 participants, below the 2,045-participant average among 397 other Heart Failure trials with a reported enrollment target (27% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06699056, a study of Heart Failure and Myocardial Infarction, is actively recruiting participants, sponsored by Peerbridge Health.
- RECRUITING
- Registry status
- 1,500 participants
- Enrollment target
- 8
- Study locations
Study 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.
Primary Outcome
The primary endpoint of this trial is to demonstrate substantial agreement between EF severity categories determined by the CorEFS Software using 5 minutes of Peerbridge COR™ ECG data and the subject's EF severity category established through ultrasound echocardiography, the gold standard for EF classification. The study includes four co-primary endpoints, representing agreement measures within each of the four EF severity categories defined by the American Society of Echocardiography (ASE) Scal
Conditions Studied
Interventions
- DEVICE 15-minutes of sitting during COR ECG Acquistion
Study Locations (8)
Texas
- Texas Cardiac Arrhythmia Research Foundation - Austin
- South Heart Clinic - Weslaco
California
- Orange County Heart Institute - Orange
Florida
- Peerbridge Health - Melbourne
Michigan
- Henry Ford Hospital - Detroit
New Jersey
- Hackensack University Medical Center - Hackensack
New York
- Mount Sinai Hospital - New York
North Carolina
- Moses H. Cone Memorial Hospital - Greensboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2024-11-21 |
| Est. Completion | 2025-09 |
What NCT06699056 shows while recruiting
NCT06699056 is an observational study that tracks outcomes without assigning an intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus, below the 2,045-participant average among 397 other Heart Failure trials with a reported enrollment target (27% lower).
The record links to 10 conditions, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which 15-minutes of sitting during COR ECG Acquistion is the first listed.
NCT06699056 lists 8 locations in 7 states (Texas, California, Florida).
Frequently Asked Questions
What is clinical trial NCT06699056 about?
NCT06699056 is a clinical study titled "AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor". 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 (...
What is the current status of trial NCT06699056?
This trial is currently recruiting. The enrollment target is 1,500 participants. The study started on 2024-11-21. Estimated completion is 2025-09.
What conditions does trial NCT06699056 study?
This clinical trial studies the following conditions: Heart Failure, Myocardial Infarction, Ischemic Heart Disease, Cardiotoxicity, Valvular Heart Disease.
What interventions are being tested in trial NCT06699056?
The interventions under investigation include: 15-minutes of sitting during COR ECG Acquistion (DEVICE).
Who is sponsoring clinical trial NCT06699056?
This trial is sponsored by Peerbridge Health, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06699056 being conducted?
This trial has 8 study locations across California, Florida, Michigan, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06699056's enrollment target sits among peer trials
1,500 54th of 397 higher than 340 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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