Valtech Cardinal Adjustable Semi-Rigid Annuloplasty Ring System For Treatment of Mitral Valve Regurgitation in Open Surgical Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Percentage of Subjects with Valtech Cardinal Mitral Heart Valve Device Technical Success
研究概览
简要总结
Annuloplasty device for repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation. Unlike conventional annuloplasty ring, the Cardinal system offers the clinician the opportunity to make adjustments after weaning from cardiopulmonary bypass. Adjustability is expected to reduce the number of patients leaving the operating room with residual regurgitation after mitral valve repair.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is a candidate for mitral valve repair.
- •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
- •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 prosthetic mitral valve or 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
Percentage of Subjects with Valtech Cardinal Mitral Heart Valve Device Technical Success
时间窗: Day of surgery
Technical success of the implantation of the Cardinal Ring defined as the ability to size the annulus, place the sutures on the ring, lower the ring onto the valve, adjust the ring to the required size and disconnect the adjustment tool.
Percentage of Subjects with Successful Off Pump Adjustment of their Valtech Cardinal Mitral Annuloplasty Ring
时间窗: Day of surgery
The technical feasibility of "off cardiac bypass pump" adjustment during surgery, when required of the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.
Subject's Mitral Valve Regurgitation (MR) Post-procedure as Compared to Baseline
时间窗: At the end of the procedure on the day of surgery compared to baseline.
The percentage of subjects that had a reduction of their pre-operative mitral regurgitation grade as compared to the mitral regurgitation grade at the end of the procedure with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.
Subject's Mitral Valve Regurgitation (MR) at Discharge as Compared to Baseline
时间窗: Day of discharge compared to baseline.
The percentage of subjects that had a reduction of their pre-operative mitral regurgitation grade as compared to the mitral regurgitation grade at hospital discharge with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.
Subject's Mitral Valve Regurgitation (MR) at 30 Days as Compared to Baseline
时间窗: 30 days compared to baseline.
The percentage of subjects that had a reduction of their pre-operative mitral regurgitation grade as compared to the mitral regurgitation grade at 30 days with the Valtech Cardinal Mitral Heart Valve Annuloplasty Ring.
次要结局
- Subject's Device Related Adverse Event Rate(6 months)