EDEN Intracardiac Electrogram Recording and Classifying System

Not Applicable

Not yet recruiting

• Conditions: Ventricular Arrhythmia

• Registration Number: NCT07137455
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-08-13
• Study First Submitted: 2025-08-19
• Study First Submitted QC: 2025-08-21
• Study First Posted: 2025-08-22
• Last Update Submitted: 2025-10-02
• Last Update Posted: 2025-10-03
• Study Start: 2025-10-08
• Primary Completion: 2026-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Classifier accuracy	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.

Trial Locations

Locations (1)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States