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Предстои набиране Не е приложимо NCT07353710

A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure

Не е приложима фаза (напр. обсервационно)
Заболявания: Atrial Arrhythmia Intracardiac Echocardiography

Спонсор: Boston Scientific Corporation

Налично на: БГ
Обобщение
A first-in-human prospective data collection study including subjects who are planned to undergo an ablation procedure for any atrial arrhythmia as per medical judgement and the site's standard practice, represents the most viable means to collect human anatomy ICE images for the purpose of software development.
Кой може да участва
Inclusion Criteria: 1. Subjects who are able and willing to provide written informed consent prior to any study procedure. 2. Subjects who are planned for an ablation procedure for any atrial arrhythmia using any commercially available Boston Scientific Ablation System, per physician's judgement and hospitals' standard practice. 3. Subjects who are willing and able to participate in all testing and assessments associated with this clinical study at an approved clinical investigation center. 4. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law. Exclusion Criteria: 1. Any of the following cardiac implanted devices * Any prosthetic mitral or tricuspid heart valve, such as ring, repairs or clips * Atrial septal defect (ASD) occluders including interatrial baffle, closure device, patch, or patent foramen ovale or ASD occluder 2. Subjects with contraindications related to the use of the CHORUS IDx™ System: * Subjects with inadequate vascular access * Subjects with active systemic infection * Subjects with presence of a known intracardiac thrombus in the chamber of use 3. Women who are confirmed to be pregnant or lactating at the time of the Index Procedure 4. Presence of other medical conditions, that, in the investigator's opinion, could limit the subject's ability to participate in the study 5. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility
Места на провеждане 8
Австралия (1)
Lingard Private Hospital
Merewether
Хърватия (1)
Klinicki Bolnicki Centar Split
Split
Чехия (1)
IKEM - Institut klinicke a experimentalni mediciny
Prague
Гърция (1)
Hygeia Hospital
Athens
Malaysia (1)
Institut Jantung Negara
Kuala Lumpur
New Zealand (1)
Auckland City Hospital
Auckland
Полша (1)
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw
Сингапур (1)
National Heart Center Singapore
Singapore
Технически детайли
Статус
Предстои набиране
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
01.07.2026
Крайна дата
31.01.2027
Регистрационен номер
NCT07353710
Източник
anzctr
Запитване за медицински туризъм

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