Safety and Efficacy of Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients With Heart Failure
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- Viacor
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Reduction of mitral regurgitation
研究概览
简要总结
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device residing in the coronary sinus
详细描述
Device under Test: The Viacor® Percutaneous Transvenous Mitral Annuloplasty (PTMA) system comprises a sterile implantable cardiac device and associated custom accessories to assist implantation. The PTMA system is intended to treat functional mitral regurgitation (MR) in a heart failure patient by a less invasive method than surgical annuloplasty with greater relief of symptoms than medical management alone.
Study Objective: Functional mitral regurgitation is associated with an adverse prognosis in the heart failure patient. The objective of this study is to evaluate whether PTMA is effective in reducing mitral regurgitation in heart failure patients and whether this reduction is associated with a moderation in the adverse progression of heart failure symptoms.
Hypothesis under Test: Reduction of the severity of functional mitral regurgitation from baseline, as defined by a composite improvement of quantitative echocardiographic metrics, can be achieved safely with the PTMA device and will be associated with a measurable moderation of adverse progression of heart failure symptoms and a moderation of the deterioration of exercise capacity.
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
- •Patient has moderate functional MR: regurgitant orifice area >/= 0.20cm2 or regurgitant volume >/= 30 mL/beat or regurgitant fraction >/= 30%
- •Symptomatic heart failure NYHA Class II to IV
- •LV dysfunction (25% < LVEF < 50% by echocardiography) 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
Reduction of mitral regurgitation
时间窗: 6 months
Freedom from major adverse cardiac events (death, MI, emergent cardiac surgery, and stroke).
时间窗: 30 days
次要结局
- Improvement of 6 minute walk distance(6 months)
- Improvement in Quality of Life Score(6 months)
- Reduction of mitral regurgitation(6 months)
- Freedom from procedure-related or device-related major adverse events(6 months)