NCT03144024已完成不适用
Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency
Meshalkin Research Institute of Pathology of Circulation2 个研究点 分布在 1 个国家目标入组 308 人开始时间: 2016年9月14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
- 308
- 试验地点
- 2
- 主要终点
- tricuspid regurgitation
研究概览
简要总结
randomized study which include comparison rigid ring and band devices in treatment tricuspid regurgitation.
详细描述
study include 308 patients. Patient will be randomized and 154 patient will receive band for treatment tricuspid regurgitation, rest patient will receive rigid ring. Follow up will be 1 year. Primary outcome - freedom of moderate or severe regurgitation. Secondary outcome - RV function, quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate or severe tricuspid regurgitation
排除标准
- •refusal to participate in the study
结局指标
主要结局
tricuspid regurgitation
时间窗: 12 months
death
时间窗: 12 months
次要结局
- right ventricle function(12 months)
研究者
研究点 (2)
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