NCT04860752已完成不适用
SAPIEN 3 Ultra EU Post-Market Observational Study
Edwards Lifesciences37 个研究点 分布在 10 个国家目标入组 500 人开始时间: 2021年4月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 37
- 主要终点
- Length of Index Hospitalization
研究概览
简要总结
This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating early discharge home.
详细描述
This is a prospective, 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
- 年龄范围
- — 至 79 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Will undergo TAVI with the Edwards SAPIEN 3 Ultra System
- •Less than 80 years of age at time of the procedure
- •Low surgical risk
- •Meets clinical and procedural requirements for early discharge
- •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
- •Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
- •Cannot tolerate an anticoagulation/antiplatelet regimen
- •Active bacterial endocarditis
- •Participating in a drug or device study that has not reached its primary endpoint
结局指标
主要结局
Length of Index Hospitalization
时间窗: Discharge from hospital, expected to be within 1-5 days post-procedure
Number of days in hospital after the procedure
次要结局
- Death(1 year)
- Stroke(1 year)
- New Requirement for Permanent Pacemaker(1 year)
- Aortic Valve Reintervention(1 year)
- Aortic Regurgitation(At discharge from hospital, expected to be within 1-5 days post-procedure)
- Mean Gradient(At discharge from hospital, expected to be within 1-5 days post-procedure)
- Effective Orifice Area(At discharge from hospital, expected to be within 1-5 days post-procedure)
- Discharge Location(At discharge from hospital, expected to be within 1-5 days post-procedure)
研究者
研究点 (37)
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