Evaluation of Procedural Outcomes and Safety of Cerebral Embolic Protection Device for Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement in Routine Clinical Practice, A Multicenter, Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 10
- 主要终点
- The rate of procedural success
研究概览
简要总结
This registry is to evaluate procedural outcomes and safety outcomes of cerebral protection devices during transfemoral TAVR in real-world clinical practice.
The data from this registry will be compared with the extracted data from the TP TAVR registry(NCT038262664) using Propensity Score Matching.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 and more
- •Undergoing TAVR with the use of SENTINEL embolic protection device
- •Higher risk of cerebrovascular embolic events (any of the followings)
- •Bicuspid aortic valve
- •Calcified lesion or atherosclerosis in the ascending aorta and/or aortic arch
- •Heavy calcified aortic valve (Ca. volume > 500)
- •Chronic kidney disease
- •Prior stroke
- •Stroke risk is strongly anticipated by attending physicians
- •Compatible carotid and brachiocephalic artery anatomy for SENTINEL device as determined by Multi-Slice Computed Tomography scan or equivalent imaging modality
- •Agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
排除标准
- •Vasculature in the right extremity precluding radial or brachial access
- •Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel System access and insertion
- •Inadequate circulation to the right extremity as evidenced by signs of artery occlusion (modified Allen's test) or absence of radial/brachial pulse
- •Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature
- •Symptomatic or asymptomatic severe occlusive carotid disease requiring concomitant carotid endarterectomy/stenting
- •Undergone carotid stenting or carotid endarterectomy within the previous 6 weeks
- •Concurrent medical condition with a life expectancy of less than 1 year
结局指标
主要结局
The rate of procedural success
时间窗: 1 month
Procedural Success: Sentinel system acute delivery and retrieval (categorized as successful deployment of both filters, 1 filter, or no filter and retrieval of the system) Procedural outcomes * Procedure time(min) * Positioning time * Total fluoroscopy time * Total contrast used * Total procedure index time * Sentinel access site vascular complications related to the procedure (major and minor)
次要结局
- The event rate of stroke(1 month)
- The event rate of systemic embolic event(1 month)
- The event rate of vascular complication(1 month)
- The event rate of bleeding(1 month)
- The event rate of cardiac death(1 month)
- The event rate of myocardial infarction(1 month)
- The event rate of death from any cause(1 month)
- The event rate of repeat hospitalization(1 month)
- The event rate of acute kidney injury(1 month)
研究者
Duk-Woo Park, MD
Professor, Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
Asan Medical Center