NCT03230747进行中（未招募）不适用
Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
Edwards Lifesciences18 个研究点 分布在 2 个国家目标入组 72 人开始时间: 2017年9月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
- 试验地点
- 18
- 主要终点
- Technical Success
研究概览
简要总结
This study will evaluate the safety and functionality of the SAPIEN M3 System in patients with symptomatic, severe MR and will provide guidance for future clinical study designs utilizing the SAPIEN M3 System.
详细描述
Prospective, single-arm, multicenter early feasibility study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •18 years of age or older
- •NYHA functional class ≥ II
- •High risk of cardiovascular surgery
- •Hemodynamically stable while on heart failure medication for at least 2 weeks before the procedure
- •The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
排除标准
- •Mitral anatomy that would preclude appropriate delivery and deployment of the dock or valve
- •Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
- •Significant risk of LVOT obstruction
- •Severe right ventricular dysfunction
- •LV Ejection Fraction <30%
- •Patient is inoperable
- •Prior surgical or interventional treatment of mitral valve preventing appropriate device access and deployment
- •Need for aortic, tricuspid or pulmonic valve replacement
- •Presence of mechanical aortic valve prosthesis
- •History of cardiac transplantation
- •History of recurrent and/or unprovoked deep vein thrombosis or pulmonary embolism
- •Clinically significant untreated coronary artery disease requiring revascularization
- •Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days.
- •Stroke or transient ischemic attack within 90 days of the procedure
- •Myocardial infarction within 30 days of the procedure
- •Active bacterial endocarditis within 180 days of the procedure
- •Inability to tolerate or a medical condition precluding treatment with anti-thrombotic therapy
- •Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states
- •Hospitalization for CHF or hemodynamic instability requiring inotropic support or intra-aortic balloon pump within 30 days.
- •Irreversible, severe pulmonary hypertension
- •Patients with renal insufficiency or receiving renal replacement therapy
- •Liver disease or significantly abnormal liver function test results
- •Refusal of blood products
- •Female who is pregnant or lactating
- •Estimated life expectancy < 12 months
- •Participating in another investigational drug or device study
研究组 & 干预措施
TMVR
Experimental
Subjects will undergo transcatheter mitral valve replacement
干预措施: Edwards SAPIEN M3 System (Device)
结局指标
主要结局
Technical Success
时间窗: At the end of the procedure
Defined as meeting all the following: * Alive * Successful access, delivery and retrieval of the delivery systems * Deployment of the devices in the intended position * Freedom from emergency surgery or reintervention related to the device or access procedure
次要结局
- Reduction in mitral regurgitation (MR)(30 Days)
研究者
研究点 (18)
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