V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet Prolapse
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Technical success rate
研究概览
简要总结
The V-Chordal System is a new technology for mitral repair. The Valtech V-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" to achieve an optimal coaptation. The adjustment mechanism allows overcoming the main problem of chordal replacement by enabling accurate sizing of the chords.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Degenerative mitral insufficiency with mitral leaflet prolapsed , who are candidates for mitral valve repair according to ESC or ACC/AHA guidelines.
- •Patient able and willing to return to the implant center for follow-up visits
- •Able and willing to give informed consent and follow protocol procedures.
排除标准
- •Inadequate echocardiographic window for transthoracic imaging
- •Severe organic lesions with retraction of chordate tendineae, severly fibrotic and immobile leaflets, severely deformed subvalvular apparatus.
- •Evolving endocarditis or active endocarditis in the last 3 months.
- •Heavily calcified annulus or leaflets.
- •Congenital malformation with limited valvular tissue
- •Patient requires mitral valve replacement.
- •Previously implanted annuloplasty ring/band.
- •Patient requires aortic or pulmonic valve replacement or repair.
- •Patient is pregnant (urine HCG test result positive) or lactating.
- •Patient has a major cardiac or non-cardiac disease, which in the investigator's experience produces an unacceptable surgical risk.
- •Life expectancy of less than twelve months.
- •Patient is participating in concomitant research studies of investigational products.
结局指标
主要结局
Technical success rate
时间窗: 6 months
ability to: 1. Anchor the system in the papillary muscle; 2. Suture the leaflet; 3. Release the V-Chordal system and extract the delivery system with no lesions to adjacent tissue. 4. Technical feasibility of chordal length adjustment. When required, adjustment of chords after weaning from CPB
Efficacy
时间窗: 30 days and 6 months
The ability of the V-Chordal System to correct leaflet prolapse of the treated segments as assessed by echordiography. Correction is defined as leaflet displacement \<2 mm above the annulus in the septolateral view.
次要结局
- Incidence of Major Adverse Events (MAE).(30 days, and 6 months)