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NCT Number: NCT07137455

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....

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Key information

Conditions

Ventricular Arrhythmia

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University Hospital

Atlanta, Georgia, 30322, United States

About 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EDEN Intracardiac Electrogram Recording and Classifying System

Device

EDEN will be used to record and classify intracardiac electrograms obtained in the practice of medicine.

Primary outcomes

Classifier accuracy

Time frame: During intracardiac electrograms procedure

The primary endpoint is classification accuracy of EDEN electrograms automated classifications compared with operator-determined classifications of radial depth according to a five-element ordinal scale (cameral, subendocardial, midmyocardial, subepicardial, pericardial). Agreement will be assessed using standard metrics such as concordance.

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Aug 22, 2025
Registry last updated: Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Enrolling by Invitation