NCT03793296撤回不适用
Percutaneous Device Closure for Significant Paravalvular Leakage After Transcatheter or Surgical Valve replacement_Pilot Study
Seung-Jung Park1 个研究点 分布在 1 个国家开始时间: 2019年1月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Degree of para-valvular leakage
研究概览
简要总结
This study evaluates the effectiveness and safety of Percutaneous Device Closure for Significant Paravalvular Leakage after transcatheter or surgical valve replacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Significant Paravalvular Leakage After Transcatheter or Surgical Valve Replacement
- •Required treatment of paravalvular leakage due to heart failure or hemolysis
- •There is a formal agreement of heart team as following
- •predicted high-risk (STS score ≥8 OR Logistic EuroSCORE ≥20% OR operative mortality is ≥15%)
- •Inoperable status due to old age or frailty
- •Written consent
排除标准
- •Risk of valve embolization because of valve dehiscence or instability
- •Acute myocardial ischemia (enzyme elevation, ST elevation on EKG(electrocardiogram), or chest pain/discomfort)
- •Evidence of intracardiac mass, thrombus or vegetation on Transthoracic/Transesophageal echocardiographic study
- •Life expectancy less than 6 months due to non-cardiac disease
- •Pregnant or breastfeeding
研究组 & 干预措施
Paravalvular leak
Experimental
After transcatheter- or surgical valve replacement
干预措施: Percutaneous Device Closure: Vascular plug (Device)
结局指标
主要结局
Degree of para-valvular leakage
时间窗: 1 month
classified as none, mild, moderate or severe by doppler echocardiography according to Valve Academic Research Consortium-2(VARC-2)
次要结局
- Event rate of bleeding(1 month)
- Event rate of device success(1 month)
- Event rate of all cause death(up to 5 years)
- Event rate of stroke(up to 5 years)
- Event rate of myocardial infarction(up to 5 years)
- Event rate of acute kidney injury(1 month)
- Event rate of cardiac death(up to 5 years)
- Event rate of rehospitalization(up to 5 years)
- Event rate of infection(up to 5 years)
- Event rate of vascular complication(1 month)
研究者
Seung-Jung Park
Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Asan Medical Center
研究点 (1)
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