Cardiovalve Transfemoral Mitral Valve System in Patients at High Surgical Risk With Severe Mitral Regurgitation
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Freedom from major device or procedure related serious adverse events
研究概览
简要总结
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
详细描述
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
The purpose of this study is to evaluate the safety of the CardiovalveSystem with its associated procedure, and observe the device performance in reducing mitral regurgitation Data collected in this clinical study will include 30-day safety and performance of the device and delivery system, and long-term clinical outcomes over a follow-up of 2 years.
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
- •Age ≥ 18 years
- •NYHA functional II, III or ambulatory IV
- •Severe mitral regurgitation (MR grade 3-4+)
- •High risk for conventional open mitral valve repair or replacement surgery in the consideration of the site Heart Team (including a cardiac surgeon, a cardiologist and imaging specialist as a minimum)
- •Able to undergo Transesophageal Echocardiography (TEE).
- •Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
- •The subject commits to return for the scheduled post-operative follow-up visits at the hospital.
- •Suitable for femoral access procedure and transseptal catheterization
- •Native mitral valve geometry and size and LV outflow tract characteristics compatible with the Cardiovalve
排除标准
- •Prior stroke or TIA within 3 months
- •Acute myocardial infarction within the previous 30 days
- •Any prior heart valve surgery or transcatheter mitral intervention
- •Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
- •Rheumatic heart disease or endocarditis within the previous 3 months
- •Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
- •Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization)
- •Untreated clinically significant coronary artery disease requiring revascularization
- •Tricuspid valve disease requiring surgery or severe tricuspid regurgitation
- •Aortic valve disease requiring surgery Anatomical Exclusion Criteria (assessed by pre-procedural imaging)
- •Left Ventricular Ejection Fraction ( LVEF) <30%
- •LV end diastolic diameter > 70mm
- •Significant abnormalities of the mitral valve and sub-valvular apparatus.
- •Severe mitral annular or leaflets calcification
- •Left atrial or LV thrombus
- •Severe right ventricular dysfunction
- •Severe tricuspid or aortic valve disease General Exclusion Criteria
- •Subject who is currently participating in an investigational study, other than this study
- •Hemodynamic instability defined as systolic pressure < 90mmHg or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device, or any mechanical heart assistance
- •Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated, has an allergy to Nitinol alloys (nickel and titanium), or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications
- •Bleeding diathesis or hypercoagulable state
- •Active peptic ulcer or active gastrointestinal bleeding
- •Pulmonary artery systolic pressure >70 mmHg
- •Patients with renal insufficiency (creatinine > 2.5 mg/dL)
- •Subject with hepatic insufficiency
- •Subject has a co-morbid illness that may result in a life expectancy of less than one year
- •Active infection that requires antibiotic therapy
- •Subject is pregnant, breastfeeding or intend to become pregnant within one year
结局指标
主要结局
Freedom from major device or procedure related serious adverse events
时间窗: 30 days
Freedom from major device or procedure related serious adverse events: F. Stage 2 or 3 acute kidney injury (includes new dialysis) H. Severe hypotension, worsening of heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for \>48 h. I. Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
次要结局
- Technical success(Intraoperative)