NCT05951101招募中不适用
Evaluation of the Safety and Performance of the Zenith LAA Occlusion System and Procedure for the Mechanical Closure of the Left Atrial Appendage (LAA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Mechanical device closure
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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%
结局指标
主要结局
Mechanical device closure
时间窗: 45 days
Mechanical device closure - residual jet around the device ≤5 mm at 45 days by TOE
Procedural success
时间窗: 72 hours
Acute procedural success is defined as the delivery and release of the Zenith LAA Occlusion System in the target location (LAA) without any device or procedure related serious adverse events until the post-procedure discharge or 72 hours (whichever comes first)
次要结局
- Device related thrombus(45 days and 12 months)
- SAE(through study completion, an average of 1 year)
- Device closure(6 months)
- Device use questionnaire(up to 24 hours)
- Changes in Quality of Life score according to SF-12 questionnaire(Baseline, 45 days, 6 months and 12 months)
- Thromboembolism(12 months)
- Stroke(12 months)
研究者
研究点 (4)
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