Transcatheter Treatment of Severe Tricuspid Regurgitation Using the MitraClip System
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- MACCE
研究概览
简要总结
The aim of this study was to investigate the procedural feasibility and 30-day results of transcatheter tricuspid valve repair using the MitraClip® system (Abbott Vascular) in selected, highly symptomatic patients with severe tricuspid regurgitation (TR).
详细描述
The primary objectives of this prospective analysis were to determine the feasibility in terms of success rate and short-term clinical follow-up at 30 days. In this context procedural success was defined as reduction of at least one TR grade. At 30-days after the procedure, a clinical follow up was performed in the heart failure outpatient clinic of our department including transthoracic echocardiography for the evaluation of TR grades. Furthermore, the investigators determined NYHA functional class and the incidence of major adverse cardiac and cerebrovascular events (MACCE).
Secondary objectives were the assessment of right ventricular function, the 6-minute walk distance, NT-proBNP as well as quality of life as assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) score at 30-days follow up.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •right-sided heart failure due to moderate-to-severe tricuspid regurgitation
- •patients deemed inoperable by the heart Team
排除标准
- •poor Echo-image quality
结局指标
主要结局
MACCE
时间窗: 1-12 months
TR grade, Echo (grade 0-4)
时间窗: 1-12 months
grade 0-4: 0: no tricuspid regurgitation, 4: massive TR
次要结局
- 6 Minute walk distance(1-12 months)
- NT-proBNP(1-12 months)
- NYHA status(1-12 months)
- MLHFQ(1-12 months)
研究者
Daniel Braun, MD
MD, Attending Physician
LMU Klinikum