EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 21 years - 100 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 50 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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....
Read the full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
- INCLUSION CRITERIA
- Age \>= 21 years
- Undergoing a medically-necessary invasive cardiac electrophysiology mapping and/or ablation procedure for ventricular arrhythmia, or conduction system pacing procedure
EXCLUSION CRITERIA
- Does not consent to participate, or unable to consent to participate
- Hemodynamic instability or emergency procedure
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
EDEN Intracardiac Electrogram Recording and Classifying System
EDEN will be used to record and classify intracardiac electrograms obtained in the practice of medicine.
Device: EDEN Intracardiac Electrogram Recording and Classifying System
EDEN Intracardiac Electrogram Recording and Classifying System DEVICE
EDEN will be used to record and classify intracardiac electrograms obtained in the practice of medicine.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Classifier accuracy
Time frame: 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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Emory University HospitalAtlanta, Georgia, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Nov 15, 2026 Estimated
- Primary completion
- Nov 1, 2027 Estimated
- Study completion
- Nov 1, 2027 Estimated
- First posted
- Aug 22, 2025 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
EDEN Intracardiac Electrogram Recording and Classifying System
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026