[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07137455":3,"trial-entities:NCT07137455":72,"trial-summary:NCT07137455":75},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":34,"secondary_outcomes":39,"sex":40,"minimum_age":41,"maximum_age":42,"healthy_volunteers":43,"eligibility_criteria":44,"std_ages":52,"locations":55,"central_contacts":65,"overall_officials":66,"references":70,"see_also_links":71},"NCT07137455","10002526","EDEN Intracardiac Electrogram Recording and Classifying System","ENROLLING_BY_INVITATION","2026-11-01","2026-07-02","2026-08-04","2026-08-07","National Heart, Lung, and Blood Institute (NHLBI)","NIH",null,"Background:\n\nHeart 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.\n\nObjective:\n\nTo test the EDEN system in people having heart procedures. The new system will be used along with an approved special ECG machine.\n\nEligibility:\n\nPeople 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.\n\nDesign:\n\nResearchers will review participants' medical records. No extra tests are needed.\n\nParticipants will have their heart procedure as planned.\n\nThe 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.\n\nThe 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.\n\nNo follow-up visits are needed for this study....","Study Description:\n\nThe 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.\n\nObjectives:\n\nThe primary objective is to determine whether the classifier accurately identifies the EDEN radial depth category.\n\nEndpoints:\n\nPrimary endpoint: The primary endpoint is classifier accuracy.\n\nExploratory 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.",[18],"Ventricular Arrhythmia",[20,21],"intracardiac electrogram","radial depth","INTERVENTIONAL","DIAGNOSTIC",[25],"NA",{"count":27,"type":28},50,"ESTIMATED",[30],{"type":31,"name":6,"description":32,"armGroupLabels":33},"DEVICE","EDEN will be used to record and classify intracardiac electrograms obtained in the practice of medicine.",[6],[35],{"measure":36,"description":37,"timeFrame":38},"Classifier accuracy","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.","During intracardiac electrograms procedure",[],"ALL","21 Years","100 Years",false,{"inclusion":45,"exclusion":48,"raw_text":51},[46,47],"Age \\>= 21 years","Undergoing a medically-necessary invasive cardiac electrophysiology mapping and\u002For ablation procedure for ventricular arrhythmia, or conduction system pacing procedure",[49,50],"Does not consent to participate, or unable to consent to participate","Hemodynamic instability or emergency procedure","* INCLUSION CRITERIA\n* Age \\>= 21 years\n* Undergoing a medically-necessary invasive cardiac electrophysiology mapping and\u002For ablation procedure for ventricular arrhythmia, or conduction system pacing procedure\n\nEXCLUSION CRITERIA\n\n* Does not consent to participate, or unable to consent to participate\n* Hemodynamic instability or emergency procedure",[53,54],"ADULT","OLDER_ADULT",[56],{"facility":57,"city":58,"state":59,"zip":60,"country":61,"geoPoint":62},"Emory University Hospital","Atlanta","Georgia","30322","United States",{"lat":63,"lon":64},33.749,-84.38798,[],[67],{"name":68,"affiliation":12,"role":69},"Robert J Lederman, M.D.","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":73,"biomarkers":74},[18],[],{"nct_id":4,"found":43,"summary":14,"prompt_version":14}]