NCT07137455
EDEN Intracardiac Electrogram Recording and Classifying System
Enrolling by Invitation
NAAges 21+InterventionalDiagnosticNational Heart, Lung, and Blood Institute (NHLBI)Government-funded
~50 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:EDEN Intracardiac Electrogram Recording and Classifying System
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Classifier accuracy
Measured over During intracardiac electrograms procedure
Conditions
Where it's being run
1 sites across 1 statesGeorgia1
Study leadership
- Robert J Lederman, M.D. · PRINCIPAL_INVESTIGATOR · National Heart, Lung, and Blood Institute (NHLBI)
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Age \>= 21 years
Undergoing a medically-necessary invasive cardiac electrophysiology mapping and/or ablation procedure for ventricular arrhythmia, or conduction system pacing procedure
Exclusion
Does not consent to participate, or unable to consent to participate
Hemodynamic instability or emergency procedure
What this trial measures
- Classifier accuracyDuring 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.