Early Feasibility Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transfemoral and Transapical Delivery Systems)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Composite Major Adverse Event Rate
研究概览
简要总结
The purpose of the study is to generate early US feasibility data of the CardiAQ™ Transcatheter Mitral Valve Implant System.
The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high risk for mortality and morbidity from conventional open-heart surgery.
详细描述
Early feasibility study - multi-center, prospective, single-arm, and non-randomized study without concurrent or historical controls.
The primary objective of the study is to generate early feasibility data for the CardiAQ™ Transcatheter Mitral Valve Implant System with the Transfemoral and Transapical Delivery Systems for the treatment of moderate to severe mitral valve regurgitation in patients who are considered high risk for mortality and morbidity from conventional open-heart surgery.
The secondary objectives of the study are to evaluate the long-term safety of the device and the effects of the device on performance, functional, quality of life parameters, and technical, device, procedural, and individual patient successes.
The study is to be performed at a maximum of 5 investigational sites in the US.
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
- •NYHA Classification ≥ III
- •Left Ventricular Ejection Fraction ≥ 30%
- •Mitral Regurgitation ≥ Grade 3+
- •Subject meets anatomical and eligibility criteria for the investigational device
排除标准
- •See Protocol
结局指标
主要结局
Composite Major Adverse Event Rate
时间窗: 30-Day
次要结局
未报告次要终点