NCT00727012已完成不适用
Multicenter International Trial Ring AnnulopLasty
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- NYHA class
研究概览
简要总结
This clinical study is a multicenter, prospective non-randomized observational study without concurrent or matched controls in which 150 patients receiving an SJM® Rigid Saddle Ring will be included. The primary objective of the study is to demonstrate the effectiveness of the SJM® Rigid Saddle Ring when used in mitral valve repair procedures.
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
- •Patient requiring a mitral valve repair due to mitral degenerative or functional disease (Note: Patients that underwent concomitant procedures, e.g. coronary artery bypass grafting, are eligible for this study);
- •Patient (or legal guardian) has signed a study specific informed consent form agreeing to the data collection and follow-up requirements;
- •Patients are at least 18 years old.
排除标准
- •Patient requires replacement of the aortic, tricuspid or pulmonary valve or has a pre-existing prosthetic valve;
- •Patient is pregnant or nursing;
- •Patient has active endocarditis;
- •Patient is actively participating in another study of an investigational drug or device;
- •Patients unavailable to follow-up visit (abroad residents, patients affected by neurological disorders...);
- •Patients who are intravenous drug abusers, alcohol abusers, prison inmates or unable to give informed consent;
- •Patients with a major non-cardiac evolving disease;
- •Patients with a life expectancy less than 1 year;
- •Patients are known to be noncompliant or are unlikely to complete the study;
- •Any case in which mitral annuloplasty rings are not indicated;
研究组 & 干预措施
SJM® Rigid Saddle Ring
Other
The SJM® Rigid Saddle Ring is an annuloplasty ring comprised of a titanium core surrounded by a double-velour, polyester fabric sewing cuff.
干预措施: mitral valve repair (SJM® Rigid Saddle Ring) (Device)
结局指标
主要结局
NYHA class
时间窗: 6 months
Change in ERO (Effective Regurgitant Orifice) in cm2 calculated with PISA method at 6 months and at patient discharge compared to baseline (pre-operative).
时间窗: 6 months
次要结局
- adverse events rates(6 months)
研究者
研究点 (2)
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