Clinical Assessment of the St. Jude Medical (SJM) Percutaneous Mitral Valve Repair (PMVr) Device Concept
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Device and Procedural Success
研究概览
简要总结
The purpose of this proof-of-concept study is to assess the relative safety and feasibility of the SJM Percutaneous Mitral Valve Repair (PMVr) Device.
详细描述
Subjects will be followed-up through 6 weeks post implantation.
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
- •Subject has symptomatic or asymptomatic moderate (2+) or severe (3-4+) mitral regurgitation.
- •Subject has an ejection fraction (EF) ≥ 30%.
- •Subject is of legal age (≥18 years old).
- •Subject is planned to undergo surgical repair or replacement of the mitral valve for symptomatic or asymptomatic posterior leaflet mitral prolapse.
排除标准
- •Subject requires a complex mitral valve repair or has isolated anterior prolapse.
- •Subject has mitral valve stenosis in which the annulus opening is <10mm. Subject has valve disease other than mitral which requires surgical intervention.
- •Subject requires a concomitant procedure.
- •Subject has a pre-existing prosthetic valve in any position.
- •Subject had stenting or PCI within 6 months before the planned procedure, or is anticipated to require stenting or PCI within 6 months post-procedure.
- •Subject has calcification of the mitral leaflets or annulus which in the medical opinion of the surgical investigator would limit repair and /or implantation of the investigational device.
- •Subject has renal insufficiency or is on chronic dialysis.
- •Subject has had a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months.
- •Subject has a history of endocarditis or has active endocarditis.
- •Subject has a history of autoimmune disease.
- •Subject has significant known carotid artery disease.
- •Subject has an aorto-mitral angle of <110 degrees.
- •Subject has hypertrophic obstructive cardiomyopathy (HOCM's Disease).
结局指标
主要结局
Device and Procedural Success
时间窗: During the investigational procedure
The primary objective is to evaluate the technical feasibility and acute device deployment characteristics of the SJM PMVr Device. Technical feasibility and deployment characteristics will be defined as: * The ability of the delivery system to access the mitral valve * The ability of the device to capture mitral valve (MV) leaflet tissue * Ability to plicate MV leaflet tissue * The clip is able to be deployed in MV leaflet tissue * The delivery system is able to be removed.
次要结局
- Quantification of SAEs reported that are unique to the investigational procedure(Through 6 weeks post-implantation)