NCT04555967进行中（未招募）不适用
SAPIEN 3 Ultra System Post-Market Clinical Follow-up Study
Edwards Lifesciences20 个研究点 分布在 8 个国家目标入组 200 人开始时间: 2020年6月30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
- 200
- 试验地点
- 20
- 主要终点
- Device success per VARC-3, defined as meeting all of the following:
研究概览
简要总结
A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
详细描述
To monitor and review device performance and outcomes of the SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
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
- •Subject meets the criteria per the Indication and Contraindications according to the current IFUs.
- •Indication for Use: The Edwards SAPIEN 3 Ultra THV, the Edwards SAPIEN 3 THV, and the associated delivery systems are indicated for use in patients with severe, symptomatic, calcific aortic valve stenosis who are judged by a Heart Team, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% at 30 days, based on the STS risk score and other clinical comorbidities unmeasured by the STS risk calculator).
- •Contraindications: Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis; Inability to tolerate anticoagulation/antiplatelet therapy.
- •Subject has provided written informed consent to comply with all study procedures and follow-up visits
排除标准
- 未提供
研究组 & 干预措施
Transcatheter aortic valve implantation
干预措施: SAPIEN 3 Ultra System (Device)
结局指标
主要结局
Device success per VARC-3, defined as meeting all of the following:
时间窗: 30 days
* Technical success * Freedom from mortality * Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication * Intended performance of the valve (mean gradient \< 20 mmHg, peak velocity \< 3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation)
次要结局
- Rehospitalization (valve-related or due to worsening heart failure)(1 year)
- Stroke(30 days and 1 year)
- New conduction defects requiring permanent pacemaker(30 days)
- Paravalvular leak(30 days and 1 year)
- New onset atrial fibrillation(30 days)
- Major vascular complications(30 days)
- Acute kidney injury stage 2-3(7 days)
- Death(1 year)
- Life threatening bleeding(30 days)
- Mean aortic valve gradient(30 days and 1 year)
研究者
研究点 (20)
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