CoreValve Advance International Post Market Study: Evaluation of the Medtronic CoreValve System in a "Real-World" Patient Population.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,015
- 试验地点
- 44
- 主要终点
- Major Adverse Cardiac & Cerebrovascular Events (MACCE)
研究概览
简要总结
The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population.
详细描述
The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System for percutaneous aortic valve implantation in a "Real-World" patient population with severe aortic valve stenosis. Data collected in this study will provide additional information on the understanding of the safety and device performance and how to best treat elderly patients with severe aortic valve stenosis. In addition, health economic data will be collected to understand the improvement of quality of life and the cost effectiveness of the therapy.
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
- •Patients with severe aortic valve stenosis requiring treatment
- •Patient is an acceptable candidate for elective treatment with the Medtronic CoreValve System and in conformity with the local regulatory and medico economical context
- •Patient is above the minimum age as required by local regulations to be participating in a clinical study
- •The patient or legal representative has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form ("Patient Informed Consent Form")
排除标准
- •Currently participating in another trial
- •High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- •Pregnancy
结局指标
主要结局
Major Adverse Cardiac & Cerebrovascular Events (MACCE)
时间窗: 30 days
MACCE is defined as a composite of: * All cause mortality * Myocardial Infarction (Q-wave and non-Q-wave) * Emergent cardiac surgery or percutaneous re-intervention * Stroke The Kaplan-Meier survival analysis was used to derive the freedom from MACCE at 30 days.
次要结局
- Percentage of Participants With Device Success(up to 24 hours)
- Percentage of Participants With Procedural Success(up to 30 days)