An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip™ Device
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 511
- 试验地点
- 34
- 主要终点
- Acute Procedural Success (APS)
研究概览
简要总结
The bRIGHT EU PAS study is an observational real-world study evaluating severe tricuspid regurgitation patients treated with the Abbott TriClip™ device (bRIGHT EU Post-Approval Study).
详细描述
The TriClip™ bRIGHT EU post-approval study (PAS) study is designed to confirm the safety and performance of the TriClip™ device in a contemporary real-world setting. The bRIGHT PAS study is a prospective, single arm, open-label, multi-center, post market registry, conducted to satisfy condition of CE Marking for the TriClip™.
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
- •Subjects (>=18 years age) have severe tricuspid regurgitation and are symptomatic despite medical therapy.
- •Subjects eligible to receive the TriClip™ per the current approved Indications for Use.
- •Subject must provide written informed consent prior to study procedure.
排除标准
- •1. 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
Acute Procedural Success (APS)
时间窗: up to 30 days
The primary endpoint is Acute Procedural Success (APS) defined as successful implantation of the TriClip™ device with resulting TR reduction at least 1 grade at discharge (30-day echocardiogram will be used if discharge is unavailable or uninterpretable). Subjects who die or undergo tricuspid valve surgery before discharge are considered to be an APS failure.
次要结局
- Composite endpoint of all-cause mortality or TR re-intervention(at 1 year follow-up)