ENRAPT-MR Trial: Epicardial Mitral Repair
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Safety - 30 - Day Major Adverse Event Rate
研究概览
简要总结
Mitral Touch System
This device is designed to epicardially reshape the mitral valve annulus without the need for cardiopulmonary bypass (CPB) and open heart access (atriotomy), in patients with left ventricular dilation and ischemic or functional MR (mitral regurgitation (MR)).
详细描述
Mitre Medical has developed an epicardial mitral annuloplasty device that can be implanted concomitant during planned coronary artery bypass surgery to help treat the MR patients. The Mitral Touch is designed to restore the S-L dimension and has the advantage of being placed without stopping the heart and placing the patient on a bypass pump.
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
- •Patient has moderate (2+), moderate-to-severe (3+) or severe (4+) ischemic or functional Mitral regurgitation per 2D or 3D echocardiography, symptomatic or asymptomatic
- •Patient is 18 years of age or older
- •Patient is willing and able to sign informed consent form
排除标准
- •History of endocarditis or current endocarditis
- •Structural abnormalities of the leaflets and papillary muscles*
- •Dysfunctional chordae*
- •Any prior cardiac surgery including but not limited to CABG, Mitral Valve repair surgery, mechanical prosthetic Valve, or ventricular assist device, prior sternotomy*
- •Ejection fraction <25%
- •New York Hheart Association (NYHA) class IV
- •MV diameters > 7cm
- •Myxomatous Mitral regurgitation
- •Renal insufficiency (eGFR < 30 ml/min)
- •Severely calcified (posterior) Mitral Valve annulus
- •Women who are pregnant (by history of menstrual period or pregnancy test if history is considered unreliable)
- •Any coronary artery calcification at site of placement as determined by angiogram.
- •Abnormal cardiac anatomy discovered prior to surgery or during procedure.
- •Pericardial adhesions
- •NOTE: Patients with prior or concurrent mitral chordae repair (example: PTFE or Neochord) are potential candidates for the MitralTouch
结局指标
主要结局
Safety - 30 - Day Major Adverse Event Rate
时间窗: 30-Days
30 - Day Major Adverse Event Rate All-cause mortality Stroke Life-threatening bleeding (MVARC scale) Major vascular complications Major cardiac structural complications Stage 2 or 3 acute kidney injury (includes new dialysis) Severe hypotension, worsening of heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for \>48 h Emergency surgery or re-intervention related to the device or access procedure
次要结局
- Technical Success - MR Reduction(30-Days, 6 Months, 12 Months)
- Technical Success - Septa-Lateral Reduction(Implantation, 6 Months, 12 Months)
- Technical Success - Coaptation Length Increase(30-Days, 6 Months, 12 Months)
- Technical Success - Improvement in NYHA Classification(6 & 12 Months)