An Observational, Prospective Evaluation of the SJM Epic Valve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 761
- 主要终点
- Hemodynamic performance
研究概览
简要总结
This study is a multi-center, prospective, non-randomized, observational study. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic valve.
详细描述
This study is a multi-centered, multi-country, prospective, non-randomized, observational study, without concurrent or matched controls, conducted under a common protocol. Bayesian methods will be used for the design and analysis of this study. The Bayesian model will determine if the data for the valve configurations are poolable. Bayesian methods also provide a means of determining the appropriate stopping time for the study based on the amount of information generated. The objectives of this study are to confirm the clinical safety and efficacy of the SJM Epic Valve by establishing the following:
- adverse effect rates
- clinical status as indicated by NYHA functional classification
- hemodynamic performance
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
- •The patient requires replacement of the aortic and/or mitral valve (Note: Patients undergoing concomitant procedures, e.g. coronary artery bypass grafting, valve repair, are eligible for this study).
- •The patient (or legal guardian) has signed a study-specific informed consent, agreeing to the data collection and follow-up requirements.
- •The patient is of legal age in host country.
排除标准
- •Patient already has a prosthetic valve, other than the aortic and/or mitral valve being replaced at this time.
- •The patient requires replacement of the tricuspid or pulmonary valve.
- •The patient is pregnant or nursing.
- •Patient has active endocarditis.
- •Patient is actively participating in the study of an investigational drug or device.
- •Patient has had an acute preoperative neurological event.
- •The patient is undergoing renal dialysis.
- •Patient is an intravenous drug abuser, alcohol abuser or prison inmate.
- •Patient has an inability or unwillingness to return for the required follow-up intervals.
- •The patient had the SJM Epic Valve implanted during the clinical study but then had the bioprosthesis explanted.
结局指标
主要结局
Hemodynamic performance
时间窗: At required follow-up visits
Adverse effect rates
时间窗: Ongoing
Clinical status as indicated by NYHA functional classification
时间窗: At required follow-up visits
次要结局
未报告次要终点