NCT03575039Unknown不适用
The VITALE Study Evaluating Safety and Effectiveness/Performance of the Microport CardioFlow VitaFlow II - Transcatheter Aortic Valve System
Shanghai MicroPort CardioFlow Medtech Co., Ltd.0 个研究点目标入组 178 人开始时间: 2018年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 178
- 主要终点
- Rate of all-cause mortality at 12 months post implantation
研究概览
简要总结
A prospective, single arm clinical investigation evaluating safety and effectiveness/performance of the Microport CardioFlow VitaFlowTM II - Transcatheter Aortic Valve System for the treatment of symptomatic severe aortic stenosis via transcatheter access in increased surgical risk patients
详细描述
This is a prospective, multicenter, single arm and controlled clinical investigation compared to recent historical results. The purpose is to evaluate the safety, performance and efficacy of the VitaflowTM II Transcatheter Aortic Valve system.
The entire system including valve system, delivery system and introducer system. We will implant the valve system into subjects and followed up them for 5 years after the procedure. This clinical trial will be conducted in 15 sites in Europe.
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
- •Subjects of age > 18 years
- •Subjects suffering from severe aortic valve stenosis, including bicuspid and tricuspid valves, defined as follows:
- •High-gradient aortic stenosis (mean pressure gradient across aortic valve >40 mmHg or peak velocity ≥4.0 m/s.
- •Subject has symptomatic valve stenosis presenting with NYHA ≥ Class II
- •Subjects with a documented heart team agreement of increased surgical risk as described in the population
- •ECG-gated multi-slice computed tomographic (MSCT) measurements determined an aortic annulus or supra-annular diameter ≥17 and ≤29mm. Findings of TTE, TEE and conventional aortography should be integrated in the anatomic assessment, when performed
- •Patient deemed eligible by Centralised Case Review Committee (CRC) assessment recommends VitaFlow™ II Transcatheter Aortic Valve System implantation
- •Subject can understand the purpose of the clinical investigation, has signed voluntary the informed consent form and is agreeing to the scheduled follow up requirements
排除标准
- •Arterial aorto-iliac-femoral axis unsuitable for transfemoral access as assessed by conventional angiography and/or multi-detector computed tomographic angiography (access vessel diameter incompatible with a 19 to 22F OD delivery system with integrated sheath or 21 to 24F OD sheath)
- •Aortic root anatomy condition or lesion preventing implantation or access to the aortic valve
- •Non-calcific acquired aortic stenosis
- •Native unicuspid aortic valve or congenital aortic abnormality (except for bicuspid aortic valve) not permitting TAVI
- •Previous implantation of heart valve in any position
- •Severe aortic regurgitation (>3+)
- •Severe mitral regurgitation (>3+)
- •Severe tricuspid regurgitation (>3+)
- •Severe left ventricular (LV) dysfunction (left ventricular ejection fraction < 30%)
- •Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- •Multi-vessel coronary artery disease with a Syntax score or residual Syntax score > 22 and/or unprotected left main coronary artery.
- •Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
- •Untreated cardiac conduction disease in need of pacemaker implantation
- •Uncontrolled atrial fibrillation (resting heart rate > 120bpm)
- •Active and/or suspicion of endocarditis or ongoing sepsis
- •Blood dyscrasias defined as: leukopenia (WBC<1000 mm3), thrombocytopenia (PLT<50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
- •Evidence of an acute myocardial infarction ≤ 1 month (30 days) before signing informed consent
- •Any need for emergency surgery
- •Recent (within 6 months of signing informed consent) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- •Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days prior to signing informed consent
- •Any active bleeding that precludes anticoagulation
- •Liver failure (Child-C)
- •End-stage renal disease requiring chronic dialysis or creatinine clearance < 20cc/min
- •Pulmonary hypertension (systolic pressure >80mmHg)
- •Severe chronic pulmonary disease (COPD) demonstrated by an expiratory volume (FEV1) < 750cc
- •Refusal of blood transfusion
- •A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (or inability to be anticoagulated for the index procedure), to nitinol, to dairy products, to polyethylene terephthalate (PET) or contrast media
- •Any medical, social or psychological condition that in the opinion of the investigator precludes the subject from giving appropriate consent or adherence to the required follow up procedures
- •Currently participating in another drug or device trial (excluding registries) for which the primary endpoint has not been assessed
- •Estimated life expectancy of less than 12 months
- •For female - pregnancy or intention to become pregnant prior to completion of all follow up procedures
- •Inability to comply with the clinical investigation follow-up or other clinical investigation requirements
结局指标
主要结局
Rate of all-cause mortality at 12 months post implantation
时间窗: 12 months post implantation
all-cause mortality including cardiovascular and non-cardiovascular
次要结局
- Rate of stroke (disabling and non-disabling)(at 30 days, 6 months,12 months, 2, 3, 4 and 5 years post-implantation)
- Recapture success rate (when attempted)(at 1st day post-implantation)
- Valve function(at 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation)
- Rate of Composite of all-cause mortality and disabling stroke(at 30 days, 6 months,12 months, 2, 3, 4 and 5 years post implantation)
- Initial success(within 30 days post-implantation)
- Changes in quality of life KCCQ(at 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation compared to baseline)
- Rate of implant related new and/or worsened conduction disturbances and arrhythmias, and occurrence of new permanent pacemaker implantation(at 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation)
- Changes in frailty (KATZ questionnaire)(at 30 days, 12 months, 1, 2, 3, 4 and 5 years post-implantation compared to baseline)
- Changes in cardiac function(at discharge, 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation)
- Rate of main adverse cardiac and cerebral events (MACCE)(at 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation)
- Rate of major vascular complications(at 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation)
- Successful insertion(at 1st day post-implantation)
- Changes in quality of life EQ-5D-5L(at 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation compared to baseline)
- Rate of all-cause mortality(at 30 days, 6 months and 2, 3, 4, 5 years post-implantation)
- Rate of acute kidney injury network stage 2 and 3 or renal alternation therapy(at 30 days, 6 and 12 months and 2 to 5 years)
- Rate of life-threatening, disabling or severe bleeding (BARC 3 to 5)(at 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation)
- Rate of the occurrence of hospitalization(at 6, 12 months, and 2, 3, 4, 5 years post-implantation)
- Rate of other TAVI-related adverse events(at 30 days, 6 and 12 months and at 2, 3, 4 and 5 years post implantation.)
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