ENRAPTUS Epicardial Mitral Touch System for Mitral Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Rate of Freedom from Major Adverse Events
研究概览
简要总结
To evaluate the safety and performance of the Mitral Touch System to treat mitral insufficiency in patients who are to undergo cardiac surgery with either a sternotomy or thoracotomy who present with moderate to severe ischemic or functional mitral regurgitation.
详细描述
The Mitral Touch Systems is intended to epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy), in patients with left ventricular dilation and mitral valve insufficiency in patients with ischemic or functional MR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate or greater (2+) ischemic
- •Functional Mitral regurgitation by 2D echocardiography using an integrative method
- •Patient is scheduled for cardiac surgery (e.g. CABG including patients on the waiting list for Heart Transplantation)
- •Patient is 22 years of age or older
- •Patient is willing and able to sign Informed Consent Form
- •Within 90 days patients should be on stable optimally uptitrated medical therapy recommended according to current guidelines23 as standard of care for heart failure therapy in the United States
排除标准
- •Any evidence of structural (chordal or leaflet) mitral valve disease
- •Inability to derive ERO, LVESVI or LVEDVI by TTE
- •Prior surgical or percutaneous mitral valve intervention
- •Contraindication to cardiopulmonary bypass (CPB)
- •Clinical signs of cardiogenic shock
- •Treatment with chronic intravenous inotropic therapy
- •Severe, irreversible pulmonary hypertension in the judgement of the investigator
- •ST segment elevation requiring intervention within 7 days prior to randomization
- •Congenital heart disease (except PFO or ASD)
- •Evidence of cirrhosis or hepatic synthetic failure
- •Renal insufficiency (eGFR < 30 ml/min)
- •History of endocarditis or current endocarditis
- •Ejection fraction <25%
- •NY heart class IV
- •MV diameters > 7cm
- •Any coronary artery calcification at site of placement as determined by angiogram
- •Myxomatous mitral regurgitation
- •Women who are pregnant (by history of menstrual period or pregnancy test if history is considered unreliable)
- •Abnormal cardiac anatomy discovered prior to surgery or during procedure
- •Pericardial adhesions
- •Insufficient clinical signature reduction of mitral regurgitation during device sizing and placement. (No device remains, patient moved to only 30-Day follow-up.)
结局指标
主要结局
Rate of Freedom from Major Adverse Events
时间窗: Procedure through 30 days
Freedom from Major Adverse Events such as death, stroke, Increase of NYHA \>1, Re-Hospitalization or reoperation of the Mitral Valve
次要结局
- Rate of Technical Feasibility to implant the Mitral Touch Device(Procedure)
- Rate of Freedom from Serious Adverse Events from Implantation of the Mitral Touch Device(procedure)