NCT04351984已完成不适用
Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation Pilot Study
Duk-Woo Park, MD1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2020年10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
- 5
- 试验地点
- 1
- 主要终点
- Mitral regurgitation
研究概览
简要总结
This study is to evaluate the efficacy and safety of Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.
- •Age 19 and more
- •Written informed consent
排除标准
- •Patients who cannot tolerate procedural anticoagulation or post-procedural antiplatelet regimen
- •Active endocarditis of the mitral valve
- •Rheumatic mitral valve disease
- •Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus
结局指标
主要结局
Mitral regurgitation
时间窗: 1 month
次要结局
- Successful valvuloplasty(5 days)
- All cause death(1 year)
- Re-hospitalization(1 year)
- Acute kidney dysfunction(5 days)
- Vascular complication(5 days)
- Bleeding(5 days)
- Stroke(1 year)
- Myocardial infarction(1 year)
研究者
Duk-Woo Park, MD
Associate Professor, Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine
Asan Medical Center
研究点 (1)
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