EDEN Intracardiac Electrogram Recording and Classifying System
NCT ID: NCT07137455
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2025-11-13
2026-11-01
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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EDEN Intracardiac Electrogram Recording and Classifying System
EDEN will be used to record and classify intracardiac electrograms obtained in the practice of medicine.
EDEN Intracardiac Electrogram Recording and Classifying System
EDEN will be used to record and classify intracardiac electrograms obtained in the practice of medicine.
Interventions
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EDEN Intracardiac Electrogram Recording and Classifying System
EDEN will be used to record and classify intracardiac electrograms obtained in the practice of medicine.
Eligibility Criteria
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Inclusion Criteria
* Undergoing a medically-necessary invasive cardiac electrophysiology mapping and/or ablation procedure for ventricular arrhythmia, or conduction system pacing procedure
Exclusion Criteria
* Hemodynamic instability or emergency procedure
21 Years
100 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Responsible Party
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Principal Investigators
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Robert J Lederman, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)
Locations
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Emory University Hospital
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Robert Lederman, M.D.
Role: primary
Other Identifiers
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002526-H
Identifier Type: -
Identifier Source: secondary_id
10002526
Identifier Type: -
Identifier Source: org_study_id