NCT03779490进行中（未招募）不适用
Transcatheter Repair of Tricuspid Regurgitation With Cardioband TR System Post-Market Clinical Follow-Up Study (TriBAND): A European Prospective, Multicenter Post-market Clinical Follow-up Study to Assess Transcatheter Tricuspid Valve Repair With Edwards Cardioband TR System in Patients With Symptomatic Chronic Functional Tricuspid Regurgitation.
Edwards Lifesciences14 个研究点 分布在 3 个国家目标入组 150 人开始时间: 2019年7月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 14
- 主要终点
- Procedure Success
研究概览
简要总结
The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System.
详细描述
The purpose of the study is to assess the safety and the effectiveness of the Cardioband Tricuspid Reconstruction System. This is a multi-center, prospective, single-arm Post-Market Clinical Follow up Study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eighteen (18) years of age or older
- •Moderate or greater functional Tricuspid Regurgitation (TR)
- •Patient is eligible to receive the Edwards Cardioband TR System per the current approved indications for use.
排除标准
- •Patients deemed anatomically unsuitable for the device by echocardiography
- •Patients in whom transesophageal echocardiography (TEE) is contraindicated
- •Previous tricuspid valve repair or replacement
- •Severe aortic, mitral and / or pulmonic valve stenosis
- •Severe aortic, mitral and / or pulmonic valve regurgitation
- •Renal Insufficiency requiring dialysis or severe kidney renal disease
- •Life expectancy of less than twelve months
- •Patient is pregnant or lactating
结局指标
主要结局
Procedure Success
时间窗: Hospital discharge, 2-7 days post-procedure
Reduction in severity of Tricuspid Regurgitation at discharge.
次要结局
- Major Adverse Event Rate(30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
- Change in Quality of Life - EQ-5D-5L(30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
- Change in Quality of Life - KCCQ(30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
- Procedure Success(30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
研究者
研究点 (14)
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