NCT02478008终止不适用
A Clinical Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transapical Delivery System)
Edwards Lifesciences9 个研究点 分布在 4 个国家目标入组 2 人开始时间: 2015年6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
- 2
- 试验地点
- 9
- 主要终点
- Composite Major Adverse Event Rate
研究概览
简要总结
The purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System.
The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high or extreme risk for mortality and morbidity from conventional open heart surgery.
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
- 65 Years 至 —（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 eligibility criteria for the investigational device
排除标准
- 未提供
结局指标
主要结局
Composite Major Adverse Event Rate
时间窗: 12-Month
次要结局
未报告次要终点
研究者
研究点 (9)
Loading locations...
相似试验
撤回
不适用
Early Feasibility Study of the CardiAQ™ TMVI System (Transfemoral and Transapical DS)Mitral InsufficiencyHeart Valve DiseaseHeart DiseaseCardiovascular DiseaseNCT02515539Edwards Lifesciences
已完成
不适用
A Clinical Study of the CardiAQ* Transcatheter Mitral Valve Implantation (TMVI) System<br>(Transapical Delivery System)leaky heart valve10046973mitral regurgitationNL-OMON41986CardiAQ Valve Technologies, Inc.45
招募中
不适用
Neonatal Transcatheter Cardiac Interventions at Sohag University HospitalTranscatheter Neonatal Cardiac InterventionsNCT06126484Sohag University30
已完成
不适用
Transcatheter Aortic Valve Intervention-Live TransmissionAortic Valve DisorderNCT01353287Medstar Health Research Institute110
进行中（未招募）
不适用
PrizValve® Transcatheter Aortic Valve Replacement StudyAortic Valve StenosisNCT04836897Shanghai NewMed Medical Co., Ltd.120