NCT00833014Unknown2 期
Dynamic Annuloplasty System With Activation for the Treatment of Mitral Regurgitation
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 130
- 试验地点
- 9
- 主要终点
- Freedom from major complications and SAM (Systolic Anterior Motion)
研究概览
简要总结
The device is a dynamic annuloplasty ring/band that is able to be adjusted in order to correct for mitral regurgitation intraoperatively or postoperatively, off-pump.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This patient requires mitral valve repair with or without concomitant procedures such as coronary artery bypass or another valve reconstruction or replacement.
- •This patient has been diagnosed with a diseased natural valve, based on echocardiography and is a candidate for mitral valve repair.
- •This patient is in satisfactory condition, based on the physical exam and investigator's experience, to be an average or better operative risk. (i.e., likely to survive one year postoperatively).
- •This patient is geographically stable and willing to return to the implant center for follow-up visits.
- •This patient has been adequately informed of his/her participation in the clinical study, and of what will be required of him/her, in order to comply with the protocol.
排除标准
- •This patient is less than eighteen (18) years of age.
- •This patient has a non-cardiac major or progressive disease, which in the investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than twelve months.
- •This patient has an ejection fraction < 30%.
- •This patient has a heavily calcified annulus or leaflets.
- •This patient presents with active endocarditis or has had active endocarditis in the last 3 months.
- •This patient is pregnant (urine HCG test result positive) or lactating.
- •This patient is an intravenous drug abuser or alcohol abuser.
- •This patient has a previously implanted prosthetic mitral valve.
- •This patient requires mitral valve replacement.
- •This patient has a creatinine level > 2.0 mg/dl
- •This patient has had congestive heart failure within the past 6 months requiring surgical treatment.
- •This patient has had a coronary artery ischemic event within the past 6 months.
- •This patient has a known life threatening, non-cardiac disease that will limit the patient's life expectancy to less than one year.
- •This patient is unable to take Coumadin.
- •This patient has a known untreatable allergy to contrast media or nickel.
- •This patient has had a cerebral vascular event within the past 6 months.
- •This patient is a prisoner (U.S.A. Only).
- •This patient is participating in concomitant research studies of investigational products.
- •This patient will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up.
结局指标
主要结局
Freedom from major complications and SAM (Systolic Anterior Motion)
时间窗: 6 months
次要结局
- Ability to adjust annuloplasty ring off-pump post implantation to correct for residual regurgitation, reduction of mitral valve regurgitation at follow-up visits (discharge, 30 days, 6 months)(6 months)
研究者
研究点 (9)
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