A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip® Devices (EXPAND)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,041
- 试验地点
- 57
- 主要终点
- Safety Measure: Number of Participants With Major Adverse Events (MAE)
研究概览
简要总结
The MitraClip EXPAND Study (A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices) is designed to confirm the safety and performance of the MitraClip NTR System and MitraClip XTR System.
详细描述
The data collected in this study will be used to evaluate device outcomes and characterize trends in patient selection for MitraClip therapy in contemporary real-world use. Moreover, the data will be assessed to identify patient or mitral valve anatomical characteristics that may be most appropriate for these next generation devices.
The MitraClip EXPAND Study will be conducted on commercial MitraClip NTR System and MitraClip XTR System that have received CE Mark and/or FDA approval as required.
Up to 1,000 subjects at a maximum of 60 sites in Europe and the US were initially planned to enroll in the MitraClip EXPAND Study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subjects who give consent for their participation
- •Subjects scheduled to receive the MitraClip per the current approved indications for use
- •Subjects with Symptomatic MR (≥3+)
排除标准
- •Subjects participating in another clinical study that may impact the follow-up or results of this study
结局指标
主要结局
Safety Measure: Number of Participants With Major Adverse Events (MAE)
时间窗: At 30 Days
MAE was defined as a composite of all-cause Death, Myocardial Infarction, Stroke, or non-elective Cardiovascular (CV) surgery for device related complications (CEC adjudicated).
Performance Measure: Number of Participants With Mitral Regurgitation (MR) Reduction to ≤2+
时间窗: At 30 days
The performance was measured by Mitral Regurgitation (MR) Reduction to ≤2+ at 30-day visits.
次要结局
未报告次要终点