Mitroflow Aortic Pericardial Heart Valve With Phospholipid Reduction Treatment Post Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- LivaNova
- 入组人数
- 186
- 试验地点
- 26
- 主要终点
- Rate of structural Valve Deterioration in Implanted Patients
研究概览
简要总结
Prospective, non-randomized, multicenter post-approval study to collect long term clinical and echographic data on Mitroflow DL patients.
详细描述
The purpose of this clinical investigation is to evaluate the safety and efficacy of the Mitroflow DL valve when used to replace diseased or dysfunctional native or prosthetic aortic heart valves. The study will be conducted in a minimum of 15 centers in the United States. Patients will be evaluated at each of the following time intervals:preoperative, at implant, in the early postoperative period, at 1 year (between 11 and 13 months postoperatively), and annually for 8 years. The duration of the study is anticipated to be 8 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients is indicated for Mitroflow DL implantation according to the Instructions for Use (IFU).
- •Patient or patient's legal representative is willing to sign the informed consent.
- •Patient's preoperative evaluation indicated the need for native or prosthetic aortic valve replacement
- •Any patient amenable to aortic valve replacement with a biological prosthesis should be enrolled in the study, even in conjuction with valve repair, coronary artery bypass grafting and other procedures
- •Patient is able to return for all follow-up evaluations for the duration of the study (geographically stable).
排除标准
- •Patient is contra-indicated for Mitroflow DL implantation according to the Instructions for Use.
- •The patient has a pre-existing valve prosthesis in the mitral, pulmonary, or tricsupid position.
- •Patient requires a double or triple valve replacement (repair is not considered an exclusion).
- •Patient has active endocarditis or myocarditis.
- •Patient is pregnant or lactating.
- •Patient is participating in a concomitant research study of an investigational product.
结局指标
主要结局
Rate of structural Valve Deterioration in Implanted Patients
时间窗: 8 years
To establish rates of structural valve deterioration through 8 years follow-up
次要结局
- Early and Late Rates of hemolysis, non-structural valve dysfunction, valve-related embolism, re-operation, explant and death(Early (30 days) and Late (> 30 days))
- Improvements in NYHA(8 years)
- Early and Late Valve-Related Adverse Event Rates(Early (30 days) and Late (> 30 days))
- Hemodynamic Performance(8 years)