EDEN Intracardiac Electrogram Recording and Classifying System

NCT07137455 | Enrolling By Invitation

• 2 other identifiers: 10002526002526-H
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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....

Conditions

Ventricular Arrhythmia

Keywords

intracardiac electrogram; radial depth

Outcome Measures

Primary Outcomes (1)

• Classifier accuracy

  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.

  During intracardiac electrograms procedure

Study Arms (1)

EDEN Intracardiac Electrogram Recording and Classifying System

EXPERIMENTAL

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

Device: EDEN Intracardiac Electrogram Recording and Classifying System

Interventions

EDEN Intracardiac Electrogram Recording and Classifying System DEVICE

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

EDEN Intracardiac Electrogram Recording and Classifying System

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 21 years
• Undergoing a medically-necessary invasive cardiac electrophysiology mapping and/or ablation procedure for ventricular arrhythmia, or conduction system pacing procedure

You may not qualify if:

• Does not consent to participate, or unable to consent to participate
• Hemodynamic instability or emergency procedure

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Study Officials

• Robert J Lederman, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 22, 2025
• Study Start (Estimated): April 21, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-03-25

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be made available by the end of the project or protocol or at the time of associated publication.
• Access Criteria: BioData Catalyst is supported by NHLBI and access to data is controlled by the NHLBI Data Access Committee (DAC) utilizing the database of Genotypes and Phenotypes (dbGaP) permissions infrastructure. In order to access controlled-access data in BioData Catalyst, an investigator must have an approved Data Access Request (DAR) in dbGaP.

Locations

US (1)