Transcatheter Leak Closure With Detachable Coils Following Incomplete Left Atrial Appendage Closure Procedures
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Procedural success
研究概览
简要总结
Although the clinical impact of left atrial appendage (LAA) leaks still requires confirmation, the open pouch with residual flow resulting from incomplete LAA closure may promote blood stagnation and thrombus formation, and increase the risk of thromboembolic events. The main purpose of this trial is to evaluate the safety and efficacy of percutaneous leak closure with detachable vascular coils.
详细描述
Therapies locally targeting the LAA via occlusion, exclusion, or excision have emerged as an alternative and effective approach for stroke prophylaxis in AF patients, especially those with OAC contra-indications. Despite mounting evidence of their safety and efficacy in comparison with standard oral therapy, device-related thrombus and incomplete LAA closure resulting in residual, significant leak may occur, potentially hindering an effective stroke prevention. To date, detachable coils have found a wide range of applications for transcatheter occlusion/embolization procedures (e.g., cerebral aneurysms, pulmonary, renal and cerebral arteriovenous malformations, patent ductus arteriosus, endoleaks). The main purpose of this trial is to evaluate the feasibility and efficacy of transcatheter leak closure with detachable coils in patients with evidence of incomplete percutaneous/epicardial LAA exclusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 years.
- •Presence of a significant LAA leak (moderate/severe following percutaneous occlusions or mild/severe after epicardial exclusions with the LARIAT suture delivery device).
- •Less moderate embolic risk (CHA2DS2-VASc ≥2)
- •High associated hemorrhagic risk (HASBLED ≥ 3), or absolute contraindication to OAC, or need for prolonged dual antiplatelet therapy, or history of thromboembolic events despite LAA occlusion/exclusion after other potential causes.
- •written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
排除标准
- •Life expectancy < 2 years.
- •pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- •presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
结局指标
主要结局
Procedural success
时间窗: 7 days
Procedural success, defined as successful delivery, deployment release of detachable coil(s) into the LAA, and incidence of LAA occlusion as measured by fluoroscopy and echocardiographic color Doppler jets less than 3mm by TEE at the end of the procedure.
Incidence of Major Adverse Events (MAE)
时间窗: 30 days
Rate of procedure- and device-related complications (device embolization; cardiac injury, re-intervention, and/or device-related surgery; bleeding events such as pericardial effusion requiring drainage, cranial bleeding due to any source, gastrointestinal bleeding; transient ischemic attack/stroke; systemic embolism; death; or any other event related to the device or the procedure, which requires treatment).
Rate of LAA leak closure
时间窗: 60 days
LAA occlusion will be assessed by TEE color Doppler and will be defined as absence of flow in the LAA or minimal color Doppler jets (\< 1mm).
次要结局
- Composite of all-cause mortality, stroke and bleeding(12 months)
研究者
Andrea Natale
Executive Medical Director
Texas Cardiac Arrhythmia Research Foundation