| Registry | NCT07137455 |
|---|---|
| Status | Enrolling by invitation |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, diagnostic |
| Enrollment | 50 (Estimated) |
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) (Nih) |
| Conditions | Ventricular Arrhythmia |
| Interventions | EDEN Intracardiac Electrogram Recording and Classifying System (Device) |
| Dates | start 2026-10-27 (estimated), primary completion 2026-11-01 (estimated), completion 2026-11-01 (estimated), first posted 2025-08-22, last updated 2026-10-22 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Ventricular Arrhythmia All trials of EDEN Intracardiac Electrogram Recording and Classifying System
Background:
Heart surgeons use electrocardiogram (ECG) machines to record electrical signals from the heart during procedures. Normal ECG machines connect only to the skin. Special ECG machines connect directly to the heart; they are a safer option during procedures. Researchers want to test a new ECG machine called the EDEN system.
Objective:
To test the EDEN system in people having heart procedures. The new system will be used along with an approved special ECG machine.
Eligibility:
People aged 21 years or older who need to have a heart procedure. These procedures can include (1) electrophysiology mapping or ablation; and (2) conduction system pacing.
Design:
Researchers will review participants' medical records. No extra tests are needed.
Participants will have their heart procedure as planned.
The EDEN system will be linked to the special ECG used during the procedure. An extra electrode may be placed on the participant's body. Electrodes are small stickers attached to wires that go to the machine.
The EDEN system will record and analyze electrical signals already being measured. It will not interfere with participants' care. No medical decisions well be made based on its data.
No follow-up visits are needed for this study....
Study Description:
The study tests a hardware electrocardiography appliance used to record and classify intracardiac electrograms obtained in the practice of medicine. No diagnoses or clinical decisions are based on the findings in this study.
Objectives:
The primary objective is to determine whether the classifier accurately identifies the EDEN radial depth category.
Endpoints:
Primary endpoint: The primary endpoint is classifier accuracy.
Exploratory endpoints: Correspondence of EDEN electrograms with CT and CMR findings (of myocardial segmental thickness, scar, and possibly relaxometry); Impact of abnormal conduction, induced or observed during the EP procedure, on EDEN electrogram morphology. Technical success of acquiring and classifying EDEN electrograms.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| EDEN Intracardiac Electrogram Recording and Classifying System | Experimental | Device: EDEN Intracardiac Electrogram Recording and Classifying System | EDEN will be used to record and classify intracardiac electrograms obtained in the practice of medicine. |
Sex: All, ages: 21 Years to 100 Years
* INCLUSION CRITERIA * Age >= 21 years * Undergoing a medically-necessary invasive cardiac electrophysiology mapping and/or ablation procedure for ventricular arrhythmia, or conduction system pacing procedure EXCLUSION CRITERIA * Does not consent to participate, or unable to consent to participate * Hemodynamic instability or emergency procedure
| Facility | City | Country | Status |
|---|---|---|---|
| Emory University Hospital | Atlanta, Georgia | United States |