NCT00787293暂停2 期
A Multi-center Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients With Heart Failure
适应症
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- Viacor
- 入组人数
- 30
- 试验地点
- 26
- 主要终点
- Freedom from MACE at 30 days post-procedure and quantitative MR reduction at 6 months
研究概览
简要总结
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Functional MR 2+ - 4+
- •Symptomatic heart failure, NYHA Class II to IV
- •LVEF > 25% or < 50% OR dilated mitral annulus > 30mm
排除标准
- •MR of organic origin
- •Severe mitral leaflet tethering
- •History of MI or PCI within 60 days of study procedure
- •Inability to walk a minimum of 100 meters in 6 minutes
- •Significant left main stenosis or proximal circumflex stent
- •Indication of non-patent CSO or discontinuous CS-GCV-AIV
- •Bi-ventricular with leads in CS or other devices impeding device placement
- •Severe aortic valvular disease
- •Chronic corticosteroid use other than < 20mg prednisone for arthritis
- •Significant co-morbidities
结局指标
主要结局
Freedom from MACE at 30 days post-procedure and quantitative MR reduction at 6 months
时间窗: 30 days to 6 months
次要结局
- % of patients experiencing procedure or device-related adverse events(30 days to 6 months)
- Technical procedural success: % of patients maintaining a reduction of mitral annulus A/P dimension, sustained MR reduction, and decrease in left ventricular dimensions to specified degrees(6 months)
- Clinical status: % of treated patients exhibiting improvements in defined QoL parameters(6 months)
研究者
研究点 (26)
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