Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve (RESTOR-MV)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 11
- 主要终点
- Primary effectiveness endpoint to compare the mean change in MR grade in the Coapsys group to the open-heart annuloplasty group from baseline to 12 months.
研究概览
简要总结
The purpose of this prospective, randomized, multi-center, pivotal trial is to compare the safety and effectiveness of the off-pump, closed heart Coapsys System (Myocor, Inc.) to open surgical repair of the mitral valve using an annuloplasty ring or band in patients with moderate to severe functional mitral regurgitation.
详细描述
Patient clinical evaluations will consist of 3-month, 6-month, and 12-month follow up of the primary endpoints. Additional follow up of 18-month, 24-month, and annually thereafter will also be included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grade 2, 3, or 4 functional mitral valve regurgitation per 2D echocardiography
- •Patient undergoing concomitant coronary artery bypass graft surgery, either on-pump or off-pump
- •Left ventricular ejection fraction greater than or equal to 25%
- •Age between 18 and 80 years, inclusive
- •Patient is willing and available to return for study follow up
- •Ability of the patient or legal representative to understand and provide signed consent for participating in the study.
排除标准
- •Structural abnormality of the mitral valve (e.g. calcification or thickening of the valve leaflets, ruptured papillary muscle, ruptured chordae tendinae, mitral valve prolapse, mitral stenosis, etc.)
- •Asymptomatic Grade 2 MR (those with NYHA Class < II AND LVEF > 40%)
- •Organic valve disease resulting in insufficiency or stenosis of the aortic, pulmonary or tricuspid valve requiring surgical intervention
- •Transmural myocardial infarction within 30 day period prior to surgical placement of Coapsys
- •NYHA class IV
- •Left ventricular end diastolic diameter > 7.0 cm
- •Cardiac surgery on an emergency or salvage basis
- •Left atrial or left ventricular thrombus
- •Left ventricular aneurysm
- •Previous mitral valve surgery or other previous cardiac surgery that would preclude proper placement of the Coapsys
- •Chronic renal failure requiring dialysis
- •Open chest surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis, pericarditis)
- •Active infection
- •Life expectancy of less than 24 months due to conditions other than their cardiac status
- •Participation in another investigational drug or device protocol
- •Abnormal coronary or cardiac anatomy such that the device could not be placed without interfering with those anatomical structures.
结局指标
主要结局
Primary effectiveness endpoint to compare the mean change in MR grade in the Coapsys group to the open-heart annuloplasty group from baseline to 12 months.
时间窗: 12- months
The primary safety endpoint is to compare the rate of primary adverse events (PAE's) through 12 months in the Coapsys group to the PAE rate in the open-heart annuloplasty group.
时间窗: 12- months
次要结局
- Compare heart failure symptoms, left ventricular geometry, change in MR and TR, adverse events, and hospitalization time and costs of Coapsys group to control group(12 months)