NCT01722591终止不适用
A Prospective, Multicenter, Uncontrolled Study to Evaluate the Safety and Efficacy of the Cardiapex Percutaneous Trans-apical Access and Closure System
Cardiapex Ltd.2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2013年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Successful performance of percutaneous transapical TAVI defined as: "Successful percutaneous transapical access and deployment of a single prosthetic heart valve"
研究概览
简要总结
A prospective, multicenter, uncontrolled study to evaluate the safety and efficacy of the Cardiapex percutaneous trans-apical access and closure system. The Cardiapex device intended for percutaneous access and closure of the left ventricular apex in conjunction with transapical Transcatheter Aortic Valve Implantation (TAVI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient scheduled for transapical TAVI
- •Patient ≥ 70 years of age
- •Patient able to give informed written consent
- •Patient able to attend follow up examinations
排除标准
- •Scheduled concomitant non-TAVI cardiac procedure
- •Patient with Left Ventricular Ejection Fraction (LVEF) < 30% at time of enrollment
- •Patient with known apical infarcted area
- •Patient with a distinct large vessel right at the anatomical apex9 (based on pre-operative coronary angiography
- •Patients with known lung tissue surrounding the apex and possibly interfering with the in-out puncture (based on preoperative gated CT assessment
- •Patient with contra-indications to transapical TAVI
- •Patient's inability to tolerate or comply with normal post-surgical drug regimen
- •Patient's inability to comply with required follow-ups, including echocardiography
- •Patient participation in other clinical trials within previous month
结局指标
主要结局
Successful performance of percutaneous transapical TAVI defined as: "Successful percutaneous transapical access and deployment of a single prosthetic heart valve"
时间窗: Outcome measure assessed during the TAVI surgical procedure - an average of 3 hours
次要结局
- ≤30 day apical bleeding requiring surgical intervention(30 days)
研究者
研究点 (2)
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