Navitor Japan Post-Market Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
The Navitor Japan Study is designed to evaluate the safety and performance of the Navitor™ valve used in combination with the FlexNav™ delivery system in a contemporary, real-world setting.
详细描述
A prospective, single-arm, observational, multicenter post-market clinical study enrolling approximately 100 Japanese patients with symptomatic, severe aortic stenosis. The study will evaluate the safety and performance of the Navitor TAVI system, including future commercially available iterations, as they become available in Japan. Enrolled subjects will undergo follow-up at discharge, 30 days and 1-year post-index procedure.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is eligible per the current approved indication after Heart Team discussion and intended to undergo a Navitor TAVI procedure.
- •The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the EC of the respective clinical site.
- •The patient and the treating physician agree that the subject will return for all required post-procedure follow-up visits
排除标准
- •Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU).
- •Life expectancy < 12 months from the time of informed consent due to non-cardiac co-morbid conditions.
- •In the judgment of the Investigator, patient presents with a medical, social, or psychological condition that could limit the ability or willingness to participate in the study, comply with study required testing and/or follow-up visits or that could impact scientific integrity of the study.
- •Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated.
- •Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be adequately premedicated.
- •Currently participating in an investigational drug or device study that may confound the results of this study.
- •Anatomy that makes insertion and endovascular access to the aortic valve difficult and/or impossible.
结局指标
主要结局
Primary Safety Endpoint
时间窗: 30 days post index procedure
The primary safety endpoint is all-cause mortality at 30 days post-TAVI procedure, which will be assessed descriptively
Primary Performance Endpoint
时间窗: 30 days post index procedure
The primary performance endpoint is moderate or greater paravalvular leak (PVL) at 30 days as measured on a transthoracic echocardiogram (TTE) by the echocardiographic core laboratory. This endpoint will be reported as % subjects with moderate or greater PVL at 30 days.
Primary Safety Endpoint
时间窗: 30 days post index procedure
The primary safety endpoint is all-cause mortality at 30 days post-TAVI procedure, which will be assessed descriptively
Primary Performance Endpoint
时间窗: 30 days post index procedure
The primary performance endpoint is moderate or greater paravalvular leak (PVL) at 30 days as measured on a transthoracic echocardiogram (TTE) by the echocardiographic core laboratory. This endpoint will be reported as % subjects with moderate or greater PVL at 30 days.
次要结局
未报告次要终点