NCT02255851已完成不适用
Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement
Claret Medical0 个研究点目标入组 300 人开始时间: 2014年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 主要终点
- Primary Observational Endpoint
研究概览
简要总结
The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve stenosis indicated for TAVR.
Subjects enrolled in the registry will undergo TAVR + Sentinel. Basic demographic information and detailed procedural data will be captured and documented in a registry case report form.
All Sentinel filters will be sent for histopathology at an independent core-lab.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Approved indications for commercially available CE-Marked TAVR devices.
- •Compatible left common carotid artery (6.5 - 10 mm) and brachiocephalic artery (9 - 15 mm) diameters without significant stenosis (> 70%).
- •The subject or the subject's legal representative has been informed of the nature of the registry, agrees to its provisions and has provided written informed consent as approved by the Ethics Committee of the respective site.
排除标准
- •Vasculature in the right extremity precluding 6Fr sheath radial/brachial access
- •Inadequate circulation to the right extremity as evidenced by signs of artery occlusion or absence of radial or brachial pulse
- •Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature
- •Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion
- •Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel device access and insertion
- •Patient whose brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium
- •Currently participating in an investigational drug or investigational (non CE-mark) device study
结局指标
主要结局
Primary Observational Endpoint
时间窗: Post-Procedure (day 1)
Capture rate, debris volume and histopathology analysis at day 1.
次要结局
未报告次要终点
研究者
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