NCT01074671已完成4 期
Colvin-Galloway Future® Annuloplasty Ring/Band Clinical Trial: Interventional Multi-center Prospective Clinical Outcome Study
Medtronic Cardiac Rhythm and Heart Failure16 个研究点 分布在 5 个国家目标入组 77 人开始时间: 2009年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 16
- 主要终点
- The level of mitral valve regurgitation
研究概览
简要总结
The primary goal of the study is to document the number of patients that are successfully implanted and benefit from the implantation of both a CG Future Annuloplasty ring or a band.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated the Patient Informed Consent (PIC);
- •Indicated to have a surgical repair for a given degree of moderate to severe mitral valve regurgitation;
- •Willing to return to the implanting hospital for a 9 month follow-up visit
排除标准
- •Unwilling or inability to sign the PIC;
- •Already participating in another investigational device study, if this would create bias and jeopardize scientific appropriate assessment of the current study endpoints;
- •Life expectancy of less than one year;
- •Pregnant or desire to be pregnant within 12 months of the study treatment;
- •Less than 18 years and more than 85 years of age.
研究组 & 干预措施
No control arm
Other
There is no control arm as part of the study design.
干预措施: CG Future Annuloplasty Ring/Band (Device)
结局指标
主要结局
The level of mitral valve regurgitation
时间窗: Within 3 months prior to implantation and at 9 month follow-up
Identification of the patient population for which a CG Future Annuloplasty Ring or Band is chosen to repair the mitral valve insufficiency
时间窗: Within 3 months prior to implantation
The percentage of patients that are chronically relieved from mitral valve insufficiency
时间窗: Within 3 months prior to implantation and at 9 month follow-up
次要结局
未报告次要终点
研究者
研究点 (16)
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