Набор по приглашению NCT07137455

EDEN Intracardiac Electrogram Recording and Classifying System

Без фазы С лечением Ventricular Arrhythmia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: EDEN Intracardiac Electrogram Recording and Classifying System.
Кому может быть актуально: Состояния в реестре: Ventricular Arrhythmia. Базовые параметры: 21 лет — 100 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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....

Подробное описание

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.

Вмешательства

Устройство EDEN Intracardiac Electrogram Recording and Classifying System
EDEN will be used to record and classify intracardiac electrograms obtained in the practice of medicine.

Первичные конечные точки

Classifier accuracy [Срок оценки: During intracardiac electrograms procedure]

Критерии участия

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