Valvular and Ventricular Improvement Via iCoapsys Delivery (VIVID) Feasibility Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- Intra-procedural implant safety of iCoapsys System, Peri-procedural safety of the iCoapsys System, Intra-procedural MR reduction with the iCoapsys System
研究概览
简要总结
The purpose of this prospective, non-randomized, single-arm feasibility study is to evaluate safety and feasibility of the iCoapsys System in patients with functional mitral valve insufficiency caused by annular dilation and/or papillary muscle displacement.
详细描述
Functional MR is a frequent outcome of ischemic heart disease or dilated cardiomyopathy. Patients with functional MR generally have normal valvular structures complicated by left ventricular dysfunction. Left ventricular dysfunction will often create geometric distortions that prevent complete leaflet coaptation, rendering the valve incompetent. Changes that will induce functional MR may include (i) dyskinetic or akinetic wall segments, (ii) dilation of the valve annulus or (iii) dilation of the left ventricle leading to tethering of the chordae tendinae.
The iCoapsys Device is intended to treat patients with functional MR. The device is not indicated for patients with diseased or damaged valvular structures caused by rheumatic fever, degenerative diseases, endocarditis, infiltrative diseases or congenital disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grade 3 or 4 functional mitral valve regurgitation per 2D echocardiography.
- •NYHA Class II and LVEF greater than or equal to 25% or NYHA Class III and LVEF greater than or equal to 30%
排除标准
- •History of pericarditis.
- •Creatinine > 2.2 at the time of the procedure
- •INR > 1.8 at the time of the procedure
- •Prior pericardial intervention (including CABG, pericardiotomy or pericardiocentesis).
- •Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure (e.g., stent placement).
- •Any planned therapeutic interventional or surgical procedure planned within 30 days following the index procedure
- •Open chest surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis).
- •Structural abnormality of the mitral valve
- •Valve disease resulting in insufficiency or stenosis of the aortic, pulmonary or tricuspid valve requiring intervention.
- •Pericardial effusion >5 mm via echocardiography.
- •Posterior wall end-diastolic dimension >1.3 cm.
- •Left ventricular end diastolic diameter > 7.0 cm.
结局指标
主要结局
Intra-procedural implant safety of iCoapsys System, Peri-procedural safety of the iCoapsys System, Intra-procedural MR reduction with the iCoapsys System
时间窗: Intra-procedure and peri-procedure
次要结局
- Minnesota Living with Heart Failure Questionnaire, 6-Minute Hallwalk, LV Chamber Volumes(1, 3, 6, 12, 18, 24 months and annually thereafter)