EDEN Intracardiac Electrogram Recording and Classifying System

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Study ID
NCT07137455
Status
Enrolling By Invitation

Conditions

  • Ventricular Arrhythmia

Eligibility Criteria

Sex
ALL
Age
21 Years - 100 Years
Healthy Volunteers
Not accepted

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.

Study Details

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....

Key Dates

Start date
Jun 16, 2026
Status verified
Mar 2026
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: EDEN Intracardiac Electrogram Recording and Classifying System
    EDEN will be used to record and classify intracardiac electrograms obtained in the practice of medicine.

Primary Outcome Measure

Classifier accuracy [ Time Frame: During intracardiac electrograms procedure ]

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322-

Find similar trials in Atlanta, GA

By research site
Emory University Hospital· Atlanta, GA

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