Идёт набор NCT07210151

Anatomical Navigation for Guided Electrophysiology in AFL and AFib

Без фазы С лечением Atrial Fibrillation Atrial Flutter Atrial 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: VERAFEYE Anatomic Guidance System.
Кому может быть актуально: Состояния в реестре: Atrial Fibrillation, Atrial Flutter, Atrial Arrhythmia. Базовые параметры: от 18 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: Хорватия, Чехия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

The objective of the study is to collect data on the use of the VERAFEYE Anatomical Guidance System in adult patients indicated to undergo a catheter ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF). The study will collect specific information on management of AFL/AF ablation procedures with the commercial VERAFEYE Anatomical Guidance System including but not limited to acute procedural success , and how the VERAFEYE Anatomical Guidance System is used overall. Results from this study may be used to guide development and refinement the VERAFEYE Anatomical Guidance System.

Вмешательства

Устройство VERAFEYE Anatomic Guidance System
The VERAFEYE Anatomical Guidance System will be used during standard of care, catheter-based treatments for atrial flutter and/or atrial fibrillation.

Первичные конечные точки

Acute procedural success rates during the index procedure [Срок оценки: During the procedure]

Критерии участия

Критерии включения

IC1: Subject is at least 18 years of age at the time of consent
IC2: Subject is scheduled to undergo a catheter-ablation procedure to treat AFL/AF (\*according to current international and local guidelines and per physician discretion)
IC3: Subject is able to understand and willing to provide written informed consent
IC4: Subject is able and willing to complete all study assessments associated with this clinical study at an approved clinical study site

Критерии исключения

EC1: Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion
EC2: Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the procedure)
EC3: Unrecovered/unresolved Adverse Events from any previous invasive procedure
EC4: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure.
EC5: Life expectancy less than 12 months
EC6: Current LA thrombus

Note: Screening for LA thrombus is required to be performed within 48 hours prior to or during the index procedure. Method of screening per physician discretion. If an atrial thrombus is observed prior to or during the planned index procedure, the index procedure will not begin or will be terminated before accessing the left atrium, and no ablation will be performed. The index procedure for this subject may be rescheduled to be performed within 30 days post ICF signature, provided that the thrombus is no longer present.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет