A Post-Market Study Assessment of the Safety and Performance of the MitraClip G4 System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,164
- 试验地点
- 63
- 主要终点
- Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days
研究概览
简要总结
This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.
详细描述
This is a post-market, multi-center, single-arm, prospective study to assess the safety and performance of the next generation MitraClip G4 System. The current protocol describes the design of this post-market study.
Up to 1,100 post-market, consented patients will be treated with a MitraClip G4 device according to local guidelines and IFU from the Europe and Middle East, the United States, Canada and Japan, and will be included in the analysis for the MitraClip EXPAND G4 Study. Follow-up echocardiograms will be collected at Discharge, 30 days and 1 year and 5 year at post-procedure visits. Additional clinical follow-up visits will be at 6 months (phone call), 2, 3, 4 year (office visits). Cardiovascular adverse events will be reported through 5 years to confirm safety of the MitraClip G4 System.
During the Phase 1 of the study 100 subjects were enrolled at 15 sites in the United States with the goal of evaluating the early safety and procedural outcomes associated with the MitraClip G4. The follow up duration was 30 days. Phase I was completed August 2020.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects scheduled to receive the MitraClip per the current approved indications for use
- •Subjects who give consent for their participation
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
Number of Participants With Mitral Valve Regurgitation Severity ≤2+ at 30 Days
时间窗: At 30 days
Mitral Valve Regurgitation (MR) Severity of 2+ or less at 30 days
Occurrence of Major Adverse Events (MAE) at 30 Days
时间窗: At 30 days
MAE is defined as a composite of all-cause Death, Myocardial Infarction, Stroke, or non-elective Cardiovascular (CV) surgery for device related complications.
次要结局
未报告次要终点