Edwards PASCAL Transcatheter Valve Repair System Registry: A Multicenter Observational Registry With the Edwards PASCAL Transcatheter Valve Repair System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 14
- 主要终点
- Major Adverse Events (MAEs)
研究概览
简要总结
This registry will collect prospective and retrospective clinical data on patients treated with the Edwards PASCAL Transcatheter Valve Repair System outside of the Post-Market Clinical Follow-up (PMCF) study.
详细描述
Patients treated per standard of care at their medical facilities and a written informed consent will be collected to allow the data to be collected. This registry intends to enroll patients under commercial usage and will serve as a mechanism to collect clinical data to further characterize the safety, performance and effectiveness of the PASCAL Transcatheter Valve Repair System.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 signs informed consent to participate in the registry
- •Patient is intended to or has received the PASCAL device
排除标准
- •Patient does not consent to participate
- •Patient is part of an ongoing Edwards Pre or Post Market Clinical study for the PASCAL Transcatheter Valve Repair System.
结局指标
主要结局
Major Adverse Events (MAEs)
时间窗: 30 days
Composite rate of all-cause death, myocardial infarction, stroke, heart failure hospitalization, or complication requiring transcatheter or surgical intervention (repeat transcatheter edge-to-edge repair \[TEER\] or mitral valve surgery)
Mitral Regurgitation (MR) Reduction to <=2+
时间窗: 30 days, 12 months
MR severity assessed by sites using a 5-grade scale: none/trace (0-1+), mild (1+), mild to moderate (2+), moderate to severe (3+), and severe (4+).
次要结局
- 6-Minute Walk Test (6MWT)(Baseline, 30 days, 12 months)
- New York Heart Association (NYHA) Functional Classification(Baseline, 30 days, 12 months)
- Quality of Life, as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Scores(Baseline, 30 days, 12 months)
- Quality of Life, as Assessed by EQ-5D Visual Analog Scale (VAS)(Baseline, 30 days, 12 months)