REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 14
- 主要终点
- Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale.
研究概览
简要总结
The Cardioband Transcatheter System (Cardioband) is indicated for the treatment of secondary (functional) mitral regurgitation (FMR). The Cardioband is a transcatheter system, deployed on the beating heart through a transseptal approach. The Cardioband is deployed along the posterior annulus of the mitral valve (MV) and is adjusted under trans-esophageal guidance on the beating heart. A CE mark study with 30 subjects has been completed and documented reduction of severity of mitral regurgitation (MR) and improvement in 6- minute walk test in subjects with moderate to severe MR.
Study objectives are to test the efficacy of the Cardioband in improving MR and heart failure symptoms in patients with symptomatic (New York Heart Association (NYHA) Class III-IVa), severe MR in the post-marketing setting, And to evaluate the safety of the Cardioband system in the post-marketing setting.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Severe (3+ to 4+) secondary Mitral Regurgitation
- •Symptomatic heart failure (NYHA Class III-IVa) despite guideline directed medical therapy including CRT if indicated
- •The Local Site Heart Team concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy.
- •Transfemoral access and transseptal deployment of the Cardioband is determined to be feasible
- •Subject is willing and able to provide informed consent and follow protocol
排除标准
- •LVEDD ≥ 70 mm
- •Heavily calcified annulus or leaflets
- •Significant CAD requiring revascularization
- •Active bacterial endocarditis
- •Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
- •Renal insufficiency requiring dialysis
- •Life expectancy of less than twelve months
- •Subject is participating in concomitant research studies of investigational products that have not reached their primary endpoint
- •Pulmonary hypertension ≥ 70mmHg at rest
- •Mitral valve anatomy which may preclude proper device treatment
- •Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and/or severe tricuspid regurgitation
- •Severe liver disease
- •Patient is pregnant or lactating
- •Hypersensitivity to Nickel or Chromium
- •Clinically significant bleeding diathesis or coagulopathy
- •History of mitral valve repair
- •TIA or CVA within 3 months
结局指标
主要结局
Reduction in Severity of MR at 30 Days of at Least One Category on a 0-4 Scale.
时间窗: 30 days
Percentage of Patients with Reduction in MR Severity of at least one grade at 30 days compared to baseline
次要结局
- Change in Distance Walked on 6 Minute Walk Test(6 months over Baseline)
- Change in Mitral Regurgitation Severity(6, 12, and 24 months over baseline)