ChordArt System Study for the Treatment of Mitral Regurgitation Due to Leaflet Prolapse or Flail
试验速览
- 阶段
- 不适用
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Major adverse events
研究概览
简要总结
The ChordArt System is a novel catheter based technology for mitral chordal replacement that enables controlled implantation of artificial mitral chords to treat mitral regurgitation with a minimally invasive approach. The implant is designed to allow transfemoral antegrade implantation.
详细描述
ChordArt utilizes a minimally invasive catheter based approach by which multiple artificial chordae are precisely positioned into the papillary muscle and then secured to the pathological leaflet.
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
- •Age ≥ 18 years
- •Mitral Regurgitation due to degenerative mitral leaflet prolapse or flail
- •Left Ventricular Ejection Fraction >20%
- •New York Heart Association functional class II to IV
- •Able and willing to give informed consent and follow protocol procedures.
排除标准
- •Life expectancy <1 year
- •Hemodynamic instability
- •Severe untreated ischemic disease
- •Pulmonary Hypertension
- •Any prior mitral valve surgery or transcatheter mitral valve procedure
- •Stroke or transient ischemic event within 30 days before randomization
- •Patient is pregnant (urine human chorionic gonadotropin (HCG) test result positive), planning to be pregnant or lactating.
- •Renal insufficiency
- •Acute anemia
- •Chronic obstructive pulmonary disease
- •Severe right ventricular dysfunction
- •Hepatic insufficiency
- •Patient is participating in other investigational studies
研究组 & 干预措施
Arm
The ChordArt System is intended for chordal replacement in patients with mitral valve insufficiency due to leaflet prolapse or flail delivered through a catheter based technology for mitral chordal replacement via a small incision in the thorax.
干预措施: ChordArt System (Device)
结局指标
主要结局
Major adverse events
时间窗: At 30 days from implant procedure
The frequency of pre-determined major adverse events
All-cause mortality
时间窗: At 30 days from implant procedure
The frequency of all-cause mortality
次要结局
- Technical Success(End of Implantation Procedure)
- Device Performance(At 30 days)