心腔内超声成像导管临床评价的系统化方法

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ABSTRACTIntracardiac Echocardiography（ICE）catheters enable real-time imaging the heartadjacent tissues duringinterventional procedures，withgrowingclinical significanceinstructural heartdiseaseelectrophysiology interventions.ThisarticleoutlinesthetechnicalcharacteristicsclinicalapplicationsICEcatheters，summarizestheU.S. Food Administrationpre-marketrequirements such products.Onthisbasis，thisstudydevelopsarelatively systematic frameworkclinicalevaluation keypointsICEcathetersbyconsolidatingdomestic internationalreview experiences，soliciting incorporatingopinionsfromclinical experts，ndreferencingguidancedocuments otherimaging devices.Thispaper alsoelaborates onimplementation esentials bench testing，animal studies，/or humanimaging confirmationstudies，aiming to provide reference the clinical evaluation technicalreview such products.

KEY WORDS Intracardiac echocardiography catheter;Clinical evaluation;Likert scale

心腔内超声心动图（intracardiacechocardiography，ICE）是指使用专门的心腔内超声成像导管（以下简称ICE导管）经外周血管送入心腔，对心脏及其邻近组织开展实时成像的技术。（剩余8406字）