Cerebral Protection of Acute Embolic Burden During Transcatheter Aortic Valve Implantation in Low Risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- The SENTINEL-LIR Study
研究概览
简要总结
This registry is designed to quantify embolic debris capture rate in patients at low surgical risk treated with the Sentinel System during TAVI.
详细描述
The SENTINEL-LIR Study is a multicenter, prospective registry to observe rate and type of debris capture in subjects at low surgical risk undergoing TAVI to demonstrate the positive effects of the use of the Sentinel System. Histopathology of captured debris from the Sentinel System will be analyzed.
The primary objective is to determine the presence or absence of particles of 7 discreet tissue types: acute thrombus (with or without associated tissue/foreign material), organizing thrombus, valve tissue, arterial wall/necrotic core, calcification, foreign material, and myocardium. Morphometric assessment of the debris (sizes >150 m, >500 m, and >1,000 m).
Patients will be screened for inclusion and exclusion criteria and documents which will have been reviewed and approved by the local Ethics Committee or regulatory authority prior to undergoing any study related exams or procedures.
Fifty (50) subjects will be enrolled in the study from an estimated 6 different sites.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe symptomatic aortic valve stenosis
- •Planned use of Sentinel System
- •Subject planned for transfemoral TAVI with valve system approved by U.S. FDA for low risk patients
- •STS-PROM score of less than 4% and agreement by Heart Team that patients meet criteria for low surgical risk
排除标准
- •Current or recent cerebrovascular accident (stroke, TIA) <6 months
- •Transapical, direct aortic or subclavian TAVI access
- •Carotid stenting or endarterectomy in last 6 weeks
- •Prior aortic valve replacement
- •Concomitant procedure with TAVI such as CABG, PCI, etc.
结局指标
主要结局
The SENTINEL-LIR Study
时间窗: 12 months
To determine the incidence and type of debris capture in SENTINEL devices deployed during TAVI in patients at low surgical risk
次要结局
未报告次要终点