Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 4
- 主要终点
- Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
研究概览
简要总结
The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.
详细描述
This is a prospective, non-randomized, non-controlled observational clinical trial. Up to 200 subjects will be enrolled at up to 6 participating clinical sites. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic valve. Patients will be followed and assessed after implant for up to 5 years.
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
- •18 years or older
- •Require replacement of aortic valve
- •Signed informed consent
- •Willing to return to study site for follow-up visits
排除标准
- •Active endocarditis/myocarditis (< 3 months)
- •Myocardial infarction (< 30 days)
- •Renal insufficiency/ End-stage renal disease
- •Life expectancy (< 1 year)
- •Requires multiple valve replacement/repair
- •Requiring emergent aortic valve surgery
- •Pregnant or lactating
研究组 & 干预措施
Aortic Bioprosthesis, Model 11000
Aortic valve replacement therapy
干预措施: Heart Valve Surgery (Procedure)
结局指标
主要结局
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
时间窗: Events occurring within 30 days of procedure
Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
时间窗: Events occurring >= 31 days and up through 5 years post-implant
Number of late events divided by the total number of late patient years x 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
次要结局
- Subject's Average Effective Orifice Area Measurements(Baseline through 5-Year (at each scheduled follow-up visit))
- Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.(3-6 Months and 1 through 5 Years compared to baseline)
- Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey(Baseline and one year follow-up)
- Subject's Average Mean Gradient Measurements(Baseline through 5-Year (at each scheduled follow-up visit))
- Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time(Baseline and 1 Year)