Post-Approval Study Protocol of the St. Jude Medical Biocor and Biocor Supra Valves
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 297
- 试验地点
- 34
- 主要终点
- Characterize the Hemodynamic Performance of the Valve
研究概览
简要总结
The purpose of this study is to further evaluate the long-term safety and effectiveness of the Biocor and Biocor Supra Valves.
详细描述
The clinical investigation is a multi-center, prospective, non-randomized, observational, FDA-required post-approval study designed to further evaluate the safety and effectiveness of the Biocor and Biocor Supra Valves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 or mitral 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
- •Already have had a valve replaced other than that for the scheduled replacement
- •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 is a prison inmate
- •Participating in another study
- •Had the Biocor or Biocor Supra valve implanted but then the device was explanted
- •Life expectancy less than five years
结局指标
主要结局
Characterize the Hemodynamic Performance of the Valve
时间窗: 5 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.
Number of Participants With Adverse Events
时间窗: 5 Years
Number of participants with Adverse Events
Characterize Patient NYHA Functional Classification Status
时间窗: 5 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.
次要结局
未报告次要终点