Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation (CLASP TR) Early Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 28
- 主要终点
- Composite Major Adverse Event (MAE) Rate
研究概览
简要总结
Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation
详细描述
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System
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
- •Severe functional or degenerative TR
- •Symptomatic despite medical therapy
- •The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve repair
排除标准
- •Unsuitable anatomy
- •Previous tricuspid valve repair or replacement
- •Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
研究组 & 干预措施
Treatment
Treatment with the Edwards PASCAL Transcatheter Valve Repair System
干预措施: Edwards PASCAL Transcatheter Valve Repair System (Device)
结局指标
主要结局
Composite Major Adverse Event (MAE) Rate
时间窗: 30 days
Number and percentage of patients who experienced at least one major adverse event (MAE). Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction (MI), stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency re-intervention related to the device, and major access site and vascular complications requiring intervention at 30 days.
次要结局
- Device Success(Intraprocedural)
- Procedural Success(Discharge (2-7 days))
- Clinical Success(30 days)