EDEN Intracardiac Electrogram Recording and Classifying System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Classifier accuracy
Study Overview
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....
Detailed 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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
EDEN Intracardiac Electrogram Recording and Classifying System
EDEN will be used to record and classify intracardiac electrograms obtained in the practice of medicine.
Intervention: EDEN Intracardiac Electrogram Recording and Classifying System (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported