An Observational, Prospective Evaluation of the Trifecta Valve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,022
- 试验地点
- 34
- 主要终点
- Late Adverse Event Rates
研究概览
简要总结
To confirm the clinical safety and effectiveness of the Trifecta valve.
详细描述
The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study designed to evaluate the safety and effectiveness of the Trifecta valve.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Requires aortic valve replacement (heart surgery such as bypass is allowed at the same time).
- •Legal age.
- •Signed informed consent prior to surgery.
- •Willing to complete all follow-up requirements.
排除标准
- •Pregnant or nursing women.
- •Have already had a valve replaced other than the aortic valve.
- •Needs another valve replaced.
- •Cannot return for required follow-up visits.
- •Have active endocarditis.
- •Acute preoperative neurological event (such as a stroke).
- •Renal dialysis.
- •History of substance abuse within one year, or a prison inmate.
- •Participating in another study.
- •Life expectancy less than two years.
研究组 & 干预措施
Trifecta Aortic Heart Valve
All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
干预措施: Trifecta Aortic Heart Valve (Device)
结局指标
主要结局
Late Adverse Event Rates
时间窗: Events occurring greater than or equal to 31 days post-implant.
Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:\[(Number of late adverse events/sum of late patient years) x 100\]
Characterize Patient NYHA Functional Classification Status.
时间窗: 1 year
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. The Criteria Committee of the New York Heart Association. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and Great Vessels. 9th ed. Boston, Mass: Little, Brown \& Co; 1994:253-256.
Characterize the Hemodynamic Performance of the Valve.
时间窗: 1 year
Gradient is the pressure difference from one side of the valve to the other side of the valve. For this study pressure is measured in mmHg. Mean gradient for each patient is the average of the pressure differences from one side of the valve to the other side of the valve. Mean gradient for each valve size (19mm, 21mm, 23mm, 25mm, 27mm, 29mm)is the average of the mean gradient for each patient with that valve size.
次要结局
未报告次要终点