Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post-Market Clinical Follow up
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 27
- 主要终点
- Change in tricuspid regurgitation severity (scale of 0-5) by echocardiography
研究概览
简要总结
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter tricuspid valve repair.
详细描述
The objectives of this clinical study are to collect data on the safety and effectiveness of the PASCAL System and PASCAL Precision System in improving TR, functional status, and quality of life in a post-market setting.
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
- •Patient is a candidate for transcatheter tricuspid valve repair as determined by a Heart Team
- •TR grade ≥3+ (5 grade classification)
- •Patient is eligible to receive the PASCAL device per the current approved indications for use
排除标准
- •Tricuspid valve anatomic contraindications, including previous tricuspid valve replacement
- •Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation
- •Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
- •Any patient considered to be part of a vulnerable population
结局指标
主要结局
Change in tricuspid regurgitation severity (scale of 0-5) by echocardiography
时间窗: Discharge: defined as discharge or 7 days post-procedure, whichever comes first
Reduction in TR severity as assessed by TEE pre and post-implant in the procedure room. TR severity compared to baseline will be assessed by TR grade at each follow-up interval.
Number of patients with major adverse events (MAE rates)
时间窗: 30 days
The primary safety endpoint is the proportion of patients with major adverse events (MAEs) at 30 days
次要结局
- Volume overload assessed by serial measurements(baseline, 30 days, 6 months, 12 months, annually up to 5 years)
- Functional class, functional status, and Quality of life as assessed(baseline, 30 days, 6 months, 12 months, annually up to 5 years)