NCT04414878招募中不适用
A Prospective, Multicenter, Single-arm, Objective Performance Clinical Investigation For Evaluation of the Safety and Effectiveness of MicroPort™ CardioFlow VitaFlow ™ II Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Stenosis
Shanghai MicroPort CardioFlow Medtech Co., Ltd.4 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2018年1月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 145
- 试验地点
- 4
- 主要终点
- Rate of all-cause mortality at 12 months post implantation
研究概览
简要总结
This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
详细描述
This a prospective, multi-center, single-arm, objective performance clinical investigation, aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis. A total of 145 subjects will be enrolled in 18 clinical centers within China. Clinical or telephone follow-up is scheduled at 30 days, 6 months, 12 months, and 2-5 years after valve implantation.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥70 years;
- •Symptomatic , severe, aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or effective orifice area<0.8cm² (or EOA index<0.5cm²/m²);
- •NYHA≥II class;
- •Estimated life-expectancy>12 months after implantation of the prosthetic valve;
- •Anatomically suitable for the transcatheter aortic valve implantation procedure;
- •The patients considered to high-risk or not suitable for surgical aortic valve replacement (SAVR), as assessed by two or above heart surgeons; The patient has been informed of the nature of the study, is willing to enroll in the study by signing a patient informed consent and agreeing to the scheduled follow up requirement.
排除标准
- •Acute myocardial infarction (MI) in last 30 days before the treatment;
- •Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；
- •Complicated lesion of the aortic valve (aortic stenosis with severe regurgitation); moderate-severe mitral valve stenosis; severe mitral valve regurgitation; severe tricuspid valve regurgitation;
- •Previous implantation of heart valve at any position；
- •Hemodynamic instability requiring mechanical hemodynamic support devices;
- •Need for emergency surgery for any reason;
- •Hypertrophic cardiomyopathy with obstruction;
- •Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%;Severe right ventricular dysfunction;
- •Active peptic ulcer or upper gastro-intestinal bleeding within the past 3 months;
- •Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements.
- •Congenital aortic valve stenosis or unicuspid aortic valve;
- •Vascular diseases or anatomical condition preventing the device access;
- •Active endocarditis or other active infections at the time of treatment;
- •Participating in another trial and the primary endpoint is not achieved.
- •Inability to comply with the clinical investigation follow-up or other 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
Rate of all-cause mortality including cardiovascular and non-cardiovascular death
次要结局
- Rate of major adverse cardiac and cerebrovascular events(MACCE)(at 30 days, 6 months, 1 year and annually up to 5 years post implantation)
- Valve function- degree of prosthetic valve regurgitation(at 30 days, 6 months, and 1 year post implantation)
- Rate of device success(at immediate post implantation)
- Valve function-mean prosthetic valve gradient(at 30 days, 6 months, and 1 year post implantation)
- Rate of other TAVI-related complications(at 30 days, 6 months, 1 year and annually up to 5 years post implantation)
- Rate of procedure success(at immediate post implantation)
- Valve function- effective orifice area(at 30 days, 6 months, and 1 year post implantation)
- Rate of safety events according to VARC2(at 30 days, 6 months, 1 year and annually up to 5 years post implantation)
- Rate of balloon pre-dilation success(at immediate post implantation)
- Rate of balloon post-dilation success(at immediate post implantation)
研究者
研究点 (4)
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