NCT04414865招募中不适用
A Prospective, Multi-center, Post-market Registry Study Evaluating Safety and Effectiveness of the Microport™CardioFlow VitaFlow™Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis
Shanghai MicroPort CardioFlow Medtech Co., Ltd.2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年4月26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
- 100
- 试验地点
- 2
- 主要终点
- Rate of all-cause mortality at 12 months post implantation
研究概览
简要总结
The study objective is to evaluate safety and effectiveness/performance of the Microport™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis in the real world settings.
详细描述
This is a prospective, single-arm, multi-center, observational, post-market registry study. The purpose is to evaluate the safety, performance, and effectiveness of the VitaFlow™ Transcatheter Aortic Valve System in the real world settings.Patients will be seen at pre and post procedure, discharge, 30 days, 1 year and annually up to 5 years.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥70 years;
- •Symptomatic , calcified, severe, degenerative, native aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or aortic valve area<0.8cm² (or EOA index<0.5cm²/m²);
- •The patients considered to be not suitable for surgical aortic valve replacement (SAVR);
- •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
- •Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；
- •Vascular diseases or anatomical condition preventing the device access；
- •Previous implantation of mechanical or bioprosthesis valve in the aortic position；
- •Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements；
- •Ongoing sepsis, including active endocarditis；
- •Estimated Life expectancy< 12 months；
- •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 safety events according to VARC2(at immediate, 30 days, 1 year and annually up to 5 years post implantation)
- Rate of balloon pre-dilatation success(at immediate post implantation)
- Rate of balloon post-dilatation success(at immediate post implantation)
- Rate of device success(at immediate post implantation)
- Rate of procedure success(at immediate post implantation)
- Rate of other TAVI-related complications(at immediate, 30 days, 1 year and annually up to 5 years post implantation)
- Valve function-mean transvalvular gradient(at discharge, 30 days, 1 year and annually up to 5 years post implantation)
- Valve function-effective orifice area(at discharge, 30 days, 1 year and annually up to 5 years post implantation)
- Valve function-degree of prosthetic valve regurgitation(at discharge, 30 days, 1 year and annually up to 5 years post implantation)
研究者
研究点 (2)
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