NCT06535659招募中不适用
VitaFlow Liberty™ Transcatheter Aortic Valve System Post-market Clinical Follow-up Study
Shanghai MicroPort CardioFlow Medtech Co., Ltd.6 个研究点 分布在 4 个国家目标入组 122 人开始时间: 2025年5月6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
- 122
- 试验地点
- 6
- 主要终点
- Composite rate of all-cause mortality and stroke with disability
研究概览
简要总结
This is a prospective, single-arm, multi-center, observational, post-market registry to document the clinical safety and performance of MicroPort CardioFlow VitaFlow Liberty™ Transcatheter Aortic Valve System in the routine practice for the treatment of severe aortic valve stenosis. The primary endpoint is the composite rate of all-cause mortality and stroke with disability at 12 months.
Patients will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 with severe, symptomatic, calcific aortic stenosis who are considered at high risk for surgical aortic valve replacement (AVR).
- •Subject can understand the purpose of the clinical investigation, has signed voluntarily the informed consent form and is agreeing to the scheduled follow up requirements.
排除标准
- •Pre-existing mechanical heart valve in aortic position
- •A known hypersensitivity or contraindication to all anticoagulation /antiplatelet regimens (or inability to be anticoagulated for the index procedure), to nickel or titanium, to nitinol, to dairy products, to polyethylene terephthalate (PET) or contrast media
- •Ongoing sepsis, including active endocarditis
- •Anatomically not suitable for the VitaFlow Liberty TAV system
- •Estimated life expectancy of less than 12 months
- •Any medical, social or psychological condition that in the opinion of the Heart Team precludes the subject from receiving transcatheter aortic valve replacement
- •Currently participating in another drug or device trial (excluding registries) for which the primary endpoint has not been assessed
- •Inability to comply with the clinical investigation follow-up or other clinical investigation requirements
- •Patients temporally unable to provide written informed consent (e. g. unconscious emergency patients)
结局指标
主要结局
Composite rate of all-cause mortality and stroke with disability
时间窗: 12 months post procedure
Composite rate of all-cause mortality and stroke with disability
次要结局
- NYHA Classification(From baseline to discharge (24 hours to 7 days), 30 days, 12 months and 2-5 years post procedure)
- Bioprosthesis haemodynamic function(Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation)
- Device success(30 days post implantation)
- Safety outcomes defined by VARC3(acute procedure (within 24 hours))
- Device early safety(30 days post implantation)
- Bioprosthetic valve dysfunction(12 months and 2-5 years post procedure)
研究者
研究点 (6)
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