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....

NCT Number	NCT07137455
Lead Sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Conditions	Ventricular Arrhythmia
Enrollment	50 participants
Start Date	2026-08-19
Primary Completion	2026-11-01 (estimated)
Study Completion	2026-11-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-14