NCT03836521招募中不适用
The International Multicenter Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Death
研究概览
简要总结
The objective of this study is to evaluate the procedural and clinical outcomes of patients with bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement.
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
- 19 Years 至 129 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years.
- •Severe aortic stenosis with bicuspid anatomy.
- •NYHA≥2 and/or syncope and/or angina.
- •Patient judged by the Heart Team as indicated for TAVR.
排除标准
- •Age <18 years
- •Asymptomatic patients
- •Pure aortic regurgitation.
结局指标
主要结局
Death
时间窗: 5 years
Death from any cause
次要结局
- Repeat hospitalization(5 years)
- Acute kidney injury (stage 2 or 3)(5 years)
- Mean aortic valve gradient by Doppler echocardiography(5 years)
- Bleeding(5 years)
- Vascular complication(5 years)
- Prosthetic regurgitation by Doppler echocardiography(5 years)
- Death from cardiac cause(5 years)
- Stroke(5 years)
研究者
Raj Makkar
Profssor of Medicine, University of California
Cedars-Sinai Medical Center
研究点 (1)
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