TriBEL Registry: National Belgian Registry of Percutaneous Tricuspid Valve Repair Using a Transcatheter Edge-to-edge Repair Technique
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Number of patients with a reduction in tricuspid regurgitation score by at least one grade
研究概览
简要总结
In this study, patients who have undergone or will undergo a transcatheter edge-to-edge repair (TEER) for tricuspid valve regurgitation (TR) will be followed up for 5 years. The goal of this prospective and retrospective, observational, non-randomized, multicenter registry is to confirm that TEER is a feasible, safe and effective treatment option for TR and to evaluate the long-term efficacy and safety of TEER.
The main endpoints are:
- Change in tricuspid regurgitation grade: number of patients with a reduction in tricuspid regurgitation score by at least one grade
- Composite of major adverse event: number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia)
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old
- •Eligible for TEER procedure
- •Informed consent signed
排除标准
- •Unwilling to provide informed consent
结局指标
主要结局
Number of patients with a reduction in tricuspid regurgitation score by at least one grade
时间窗: 30 days
Number of patients with a reduction in tricuspid regurgitation score by at least one grade 30 days post-procedure
Composite of major adverse event
时间窗: 1 year
Number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia)
次要结局
- Composite of major adverse event at discharge(5 days)
- Number of patients with a reduction in tricuspid regurgitation score by at least one grade 1 year post-procedure(1 year)
- Number of patients with a reduction in tricuspid regurgitation score by at least one grade 3 years post-procedure(3 years)
- Number of patients with a reduction in tricuspid regurgitation score by at least one grade 4 years post-procedure(4 years)
- Number of patients with a reduction in tricuspid regurgitation score by at least one grade 5 years post-procedure(5 years)
- Number of patients with a reduction in tricuspid regurgitation score by at least one grade at 6 months post-procedure(6 months)
- Number of patients with a reduction in tricuspid regurgitation score by at least one grade 2 years post-procedure(2 years)
- Composite of major adverse event at 5 years post-procedure(5 years)
研究者
Jan Van der Heyden
Principal Investigator
AZ Sint-Jan AV