NCT03600688进行中（未招募）不适用
Transcatheter Repair of Mitral Regurgitation With Cardioband System Post Market Study:A European Prospective, Multicenter Study to Assess Transcatheter Mitral Valve Repair With Edwards Cardioband System in Patients With Symptomatic MR
Edwards Lifesciences17 个研究点 分布在 3 个国家目标入组 200 人开始时间: 2018年6月6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
- 200
- 试验地点
- 17
- 主要终点
- Procedure Success at discharge
研究概览
简要总结
To demonstrate reduction of MR with durable performance and im-provements in functional status
详细描述
MiBAND is a prospective, single arm, European post-market study to assess the safety and efficacy of the Edwards Cardioband system. Patients will be followed up at 30D, 6months, 1, 2 and 3 years.
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
- •Age ≥ 18 years;
- •MR (≥ 2+ by echocardiography);
- •Patient is eligible to receive the Edwards Cardioband Mitral System
排除标准
- •Active bacterial endocarditis
- •Severe organic lesions with retracted chordae or congenital mal-formations with lack of valvular tissue
- •Heavily calcified annulus or leaflets
- •Patients in whom transesophageal echocardiography is contraindicated
- •Patients who cannot tolerate an anticoagulation/antiplatelet regimen
- •Patients with known severe reaction to contrast agents that cannot be adequately pre-medicated.
- •Pre-existing prosthetic heart valve or annuloplasty in the Mitral position
- •Life expectancy of less than twelve months
- •Patient is pregnant or lactating
结局指标
主要结局
Procedure Success at discharge
时间窗: Hospital discharge; approximately 2-8 days post-procedure
Reduction in Severity of Mitral Regurgitation at discharge
次要结局
- Procedure Success(30 days, 6months, 1, 2 and 3 years)
- Major Adverse Events Rate(30 days, 6months, 1, 2 and 3 years)
- Change in Quality Of Life-KCCQ(30 days, 6 months, 1, 2 and 3 years)
- Change in Quality Of Life-EQ-5D-5L(30 days, 6 months, 1, 2 and 3 years)
研究者
研究点 (17)
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