Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06699056
The ClinicalTrials.gov registry entry for NCT06699056 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,500 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,045-participant average among 397 other Heart Failure trials with a reported enrollment target (27% lower). The listed sponsor is Peerbridge Health, which has 2 total studies on file at ClinicalTrials.gov.
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 reports 8 study locations spanning 7 distinct geographic areas - top geographies include 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
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Early Feasibility Study of the NORM™ System in Heart Failure Patients (FUTURE-HFII)
RECRUITING · NA
-
Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
RECRUITING · NA
-
iCardia4HF: Multi-component mHealth Intervention for Patients With Heart Failure
RECRUITING · NA
-
A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure Who Are Intolerant or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists
RECRUITING · Phase 3
-
Circulating Markers That Underlie the Transition From Compensated Hypertrophy to Heart Failure
RECRUITING
-
Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence
RECRUITING
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.