Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 9
- 主要终点
- Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE
研究概览
简要总结
The study is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and development efforts of the Edwards FORMA Tricuspid Transcatheter Repair System.
详细描述
The early feasibility study of the Edwards FORMA Tricuspid Transcatheter Repair System is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and development efforts of the Edwards FORMA Tricuspid Transcatheter Repair System.
Data collected in this clinical study will include safety and function of the investigational system as well as up to 3 year clinical outcomes.
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
- •≥ 18 years old
- •Clinically significant, symptomatic, functional, tricuspid regurgitation (per applicable guidelines) requiring transcatheter tricuspid valve repair as assessed by the local Heart Team
排除标准
- •Tricuspid valve/right heart anatomy not suitable for the study device
- •Moderate or greater tricuspid valve stenosis
- •Severe RV dysfunction
结局指标
主要结局
Major Adverse Event Rate : Count and Percentage of Patients Who Experienced at Least One MAE
时间窗: 30 days
Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction, new need for renal replacement therapy, severe bleeding, re-intervention for study device related complications or on the previously implanted study device, and major access site and vascular complications requiring intervention at 30 days.
次要结局
- Clinical Success: Count and Percentage of Patients Who Experienced Clinical Success(30 days)
- Device Success : Count and Percentage of Patients Who Experienced Device Success(Intraprocedural)
- Procedure Success: Count and Percentage of Patients Who Experienced Procedural Success(Discharge (2-8 days))