NCT03714412撤回不适用
Feasibility Study of High Surgical Risk Patients With Severe Mitral Regurgitation Treated With the Cardiovalve Transfemoral Mitral Valve System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Freedom from major device- or procedure- related serious adverse events
研究概览
简要总结
The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery. The system is comprised of comprised of: 1) an Implant; 2) a Delivery System (DS); and 3) Accessories that are required for the implantation procedure. the procedure is performed under general anesthesia.
详细描述
The study will test the safety and performance of the Cardiovalve transfemoral mitral valve replacement system in treating patients with severe mitral regurgitation who are at high risk for open chest surgery. The system is comprised of comprised of: 1) an Implant; 2) a Delivery System (DS); and 3) Accessories that are required for the implantation procedure. The implant procedure is performed under general anesthesia, and the participants will be followed-up at discharge, 1- 3-, 6-, 12- and 24-months post-procedure, in order to check the system functionality and effect on their cardiology status.
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
- •General Inclusion Criteria:
- •2. NYHA functional II, III or ambulatory IV
- •Severe mitral regurgitation (MR grade 3-4+) with pronounced secondary MR etiology
- •Subject is on optimal guideline-directed medical therapy for heart failure for at least 30 days or CRT if indicated.
- •5. Elevated 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) based on STS/Euro Score II (per MVARC Part 1), frailty and co-morbidities.
- •6. 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.
- •8. The subject commits to return for the scheduled post-operative follow-up visits at the hospital.
- •Anatomical Inclusion Criteria
- •Suitable for femoral access procedure and trans septal catheterization
- •Native mitral valve geometry and size and LV outflow tract characteristics compatible with the Cardiovalve (as assessed by the independent Screening Committee)
排除标准
- •Cardiovascular Exclusion Criteria
- •Prior stroke or TIA within 3 months or Modified Rankin Scale ≥4 disability
- •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 or pulmonic valve disease requiring surgery
- •CRT/ICD implant within 30 days 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 or vegetation
- •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)
- •Need for emergent or urgent surgery for any reason or any planned cardiac Surgery within the next 12 months
- •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
研究组 & 干预措施
Implantation
Experimental
Eligible patients will undergo implantation with the Cardiovalve system
干预措施: Implantation (Device)
结局指标
主要结局
Freedom from major device- or procedure- related serious adverse events
时间窗: 30 days
Evaluate the safety of the Cardiovalve with its associated procedure
次要结局
- Technical success of delivery and deployment of the device(Intraoperative)
- Freedom from emergency surgery or reintervention(30 days)
- Freedom from rehospitalizations or reinterventions due to the underlying condition(30 days, 3 Months, 6 Months, 12 Months, and 24 Months)
- 6 minute walk test(30 days, 3-, 6-, 12 and 24-months)
- Improvement in quality of life from baseline(30 days, 3-, 6-, 12 and 24-months)
- NYHA class(30 days, 3-, 6-, 12 and 24-months)
- Reduction in MR grade(30 days, 3-, 6-, 12 and 24-months)
研究者
研究点 (3)
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