Transfemoral Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (EUROPE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 214
- 试验地点
- 22
- 主要终点
- Number of Deaths
研究概览
简要总结
A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), its transfemoral delivery system, and crimper accessories. The trial includes a premarket confirmatory cohort to evaluate the system performance as well as a Post Market Clinical Follow-up phase involving expanded enrollment and long-term follow-up of all patients to evaluate valve performance out to 5 years.
详细描述
Edwards Lifesciences obtained CE marking authorization for transfemoral delivery / implantation of the Edwards SAPIEN™ transcatheter heart valve (model 9000TFX) using the RetroFlex™ delivery system in August 2007 and introduced these devices for commercial distribution in the European Economic Area (EEA) in October 2007.
Clinical Sites: Up to 11 sites in Europe
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
- •All candidates for this study must meet all of the following inclusion criteria:
- •Patients must have co-morbidities such that the surgeon (Co Investigator) and interventional cardiologist (Principal Investigator) concur that the predicted risk of operative mortality is > 15% with a minimum STS Risk Calculator score of ≥ 10 and/or Logistic EuroSCORE of > 20%.
- •Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
- •The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided a written informed consent that has been approved by the reviewing Ethics Committee (EC) of the respective clinical site.
- •Subject is willing to comply with specified follow up evaluations, including possible coronary angiography and transesophageal echocardiography.
- •The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
排除标准
- •Aortic valve is a congenital unicuspid or bicuspid valve, or is non-calcified.
- •Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
- •Any therapeutic invasive cardiac procedure, other than BAV, performed within 30 days of the index procedure (or 6 months if the procedure was a drug eluting coronary stent implantation).
结局指标
主要结局
Number of Deaths
时间窗: 30 days
Number of death at 30-days from the index procedure.
次要结局
- Number of Participants With a Stroke(30 days from the index procedure)