NCT05168826进行中（未招募）不适用
SAPIEN 3 China Post Market Registry Study
Edwards Lifesciences21 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2022年1月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
- 试验地点
- 21
- 主要终点
- All-cause mortality
研究概览
简要总结
The objective of this study is to evaluate the long term safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve system in real world setting.
详细描述
This is an observational, single-arm, multicentre, post-market study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with symptomatic, severe, calcified aortic stenosis who is appropriate for the treatment with transcatheter aortic valve replacement as determined by a heart team and will undergo TAVI with the Edwards SAPIEN 3 System as part of standard-of-care treatment
- •All surgical risks as determined by the site Heart Team
- •The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
排除标准
- •Medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship
- •Considered to be part of a vulnerable population
- •Pre-existing mechanical or bioprosthetic aortic valve
- •Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
- •Cannot tolerate an anticoagulation/antiplatelet regimen
- •Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis
- •Tortuous or calcified vessels that would prevent safe entry of the dilators and sheath
- •Participating in a drug or device study that has not reached its primary endpoint
研究组 & 干预措施
Transcatheter Aortic Valve Implantation (TAVI)
干预措施: SAPIEN 3 Transcatheter Heart Valve (Device)
结局指标
主要结局
All-cause mortality
时间窗: 10 years
The number of patients that died
次要结局
未报告次要终点
研究者
研究点 (21)
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