Идёт набор NCT05951101

Zenith LAA Occlusion System

Без фазы С лечением Atrial Fibrillation Left Atrial Appendage Stroke

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: Zenith LAA Occlusion System.
Кому может быть актуально: Состояния в реестре: Atrial Fibrillation, Left Atrial Appendage, Stroke. 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: Австралия, Новая Зеландия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluation of the Safety and Performance of the Zenith LAA Occlusion System and Procedure for the Mechanical Closure of the Left Atrial Appendage (LAA)

Обзор

Demonstrate the safety and performance of the Zenith LAA Occlusion System and procedure to occlude the Left Atrial Appendage (LAA) from the left atrium (LA) using a minimally invasive technique. Indication - LAA closure in patients with non-valvular atrial fibrillation, with an ostial diameter between 18 mm and 26 mm

Подробное описание

The study objective is to demonstrate the safety and performance of the Zenith LAA Occlusion System and procedure to occlude the Left Atrial Appendage (LAA) from the left atrium (LA) using a minimally invasive technique.

Вмешательства

Устройство Zenith LAA Occlusion System
LAA closure in patients with non-valvular atrial fibrillation, with an ostial diameter between 17 mm and 25 mm

Первичные конечные точки

Procedural success [Срок оценки: 72 hours]
Mechanical device closure [Срок оценки: 45 days]

Вторичные конечные точки (7)

Device related thrombus [Срок оценки: 45 days and 12 months]
SAE [Срок оценки: through study completion, an average of 1 year]
Stroke [Срок оценки: 12 months]
Thromboembolism [Срок оценки: 12 months]
Device closure [Срок оценки: 6 months]
Device use questionnaire [Срок оценки: up to 24 hours]
Changes in Quality of Life score according to SF-12 questionnaire [Срок оценки: Baseline, 45 days, 6 months and 12 months]

Критерии участия

Критерии включения

Age ≥18 at the time of screening
Documented diagnosis of non-valvular AF
Clinical indication for LAA occlusion
Willing and able to return to and comply with scheduled follow-up visits and testing, including medical treatment as required by the protocol.
Willing and able to provide written informed consent

Критерии исключения

Within 30 days before the procedure date:

Exhibited NYHA class III or IV heart failure symptoms
Known bleeding disorders (such as bleeding diathesis, thrombocytopenia \[platelet count <100 X 109/L\], severe anaemia \[haemoglobin of <8 g/dL\], or INR >2 \[spontaneous\])

Within 90 days before the procedure date:

Documented history of myocardial infarction or unstable angina
Documented embolic stroke, TIA or suspected neurologic event
Chronic renal insufficiency (eGFR ≤15mL/min per 1.73 m2 (CKD-EPI)) or end-stage renal disease
Requires long-term oral anticoagulation therapy for a condition other than AF
Diagnosed active local or systemic infection, septicaemia, active pericarditis, or fever of unknown origin
Known acquired or inherited propensity for forming blood clots (e.g., malignancy and factor V Leiden mutation) established by prior objective testing
Contraindication to the standard of care post-implantation antithrombotic medication regime (e.g., dual antiplatelet therapy (DAPT)/direct oral anticoagulant (DOAC)
Rheumatic heart disease
Implanted mechanical valve prosthesis
Documented carotid disease, defined as greater than 70% stenosis without symptoms or greater than 50% stenosis with symptoms
Body mass index greater than 40 kg/m2
Patient is pregnant or breastfeeding or plans/desires to get pregnant within the next 12 months post-procedure
Current or planned enrolment in an investigation or study of an investigational device or investigational drug that would interfere with this study and the required follow-up
Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the study
Any other criteria (including physical and mental health), medical illness, or comorbidity which would make the subject unsuitable to participate in this study as determined by the clinical site principal investigator
Patients with known allergy or sensitivity to nitinol (nickel and titanium) or any of the other materials in the Zenith LAA Occlusion System Implant
Life expectancy of less than 1 year
Inability, unwillingness, or contraindication to undergo Trans-Oesophageal and/or Trans-Thoracic Echocardiogram (TOE/TTE) or Cardiac Computed Tomography Angiography (CCTA) imaging or any catheterisation procedures
Any anatomical condition that precludes the patient from undergoing LAA occlusion with the AuriGen Zenith LAA Occlusion System implant procedure, as determined by the principal investigator

Imaging Exclusion Criteria:

Patients with a maximal ostial left atrial appendage diameter >25 mm or <17 mm by pre-procedural ECG-gated CT scan, to fit the Zenith LAA Occlusion System
Patients where CCTA analysis suggests that the Zenith LAA Occlusion System may not be suitable
Intracardiac thrombus diagnosed by CCTA or echocardiography
Previous occlusion/ligation of the LAA (by any surgical or percutaneous method)
Documented presence of implanted closure devices (e.g. Atrial septal defect (ASD), Patent foramen ovale (PFO) or Ventricular septal defect (VSD) device) for congenital defect treatment
Documented Left Ventricular Ejection Fraction (LVEF) <30%

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

Здоровые добровольцы: Нет