NCT06008080招募中不适用
VISTA Nova Study (Navitor Post-Market Clinical Follow Up Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 57
- 主要终点
- Moderate or greater paravalvular leak at 30 days post-TAVI procedure
研究概览
简要总结
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
详细描述
The VISTA Nova Study will evaluate the safety, performance, and long-term durability of the Navitor valve in a real-world setting.
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 IRB (Investigational Review Board)/EC (Ethics Committee) 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
Moderate or greater paravalvular leak at 30 days post-TAVI procedure
时间窗: 30 days post index procedure
Assessment of paravalvular leak at 30 days post-TAVI procedure
All-cause mortality at 30 days post-TAVI procedure
时间窗: 30 days post index procedure
Death from all causes at 30 days post-TAVI procedure
次要结局
未报告次要终点
研究者
研究点 (57)
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